ABSTRACT
Human papillomavirus (HPV) infection is the leading cause of over 36,000 new cancer cases of cervical, ano- genital, and oropharyngeal cancers in the United States each year. While multi-valent vaccinations to prevent HPV infections have been available since 2006, uptake of the vaccine is well below national Healthy People 2030 targets (80% of adolescents at ages 13-15 years up-to-date with HPV vaccination). Adolescent vaccination rates are especially low in rural areas (about 11% lower than in urban areas). Compared to urban residents, rural residents have a higher incidence of HPV-related cancers and face unique barriers to HPV vaccination, including limited access to providers, fewer vaccine reminders, longer travel time to clinics, and less favorable societal norms about HPV vaccination. Moreover, rural adolescents are less likely than their urban counterparts to receive a provider recommendation for the HPV vaccine. Rural healthcare teams are often limited by a lack of systematic methods to identify and track eligible patients and/or their parents for outreach. While much is known about clinic-based approaches to improve HPV vaccination among urban residents, less is known about their effectiveness among rural residents, including rural Hispanic populations, the fastest growing sub-population in rural settings. The proposed study is designed to address these barriers by adapting and testing approaches to effectively communicate the importance of vaccination to improve HPV vaccination rates for rural populations, and the sub-populations within (e.g. Hispanic persons). Our study includes a randomized controlled trial of adapted reminders to address the needs of rural populations. We will create clinic systems to prompt vaccination for eligible children/adolescents and deliver messages to parents/caregivers, whose mode and content is specifically tailored for rural and rural Hispanic populations. Our study, Practice-based Approaches to Promote HPV Vaccination in the Safety Net (PREVENT), incorporates formative patient- and clinic-informed research to design and evaluate an automated data-driven reminder intervention using low-cost approaches (automated phone calls and text messages). We will compare usual care to Automated Patient Reminders, and to a higher-intensity intervention arm using automated messages plus linguistically and culturally tailored interventions to deliver live reminders, Automated Plus Live Patient Reminders. PREVENT’s design and evaluation will involve tailoring message mode and content for parents and caregivers of rural patients. This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among rural patients in the Mountain West. Our strong research team demonstrates successful partnerships with primary care practices in rural populations. Once implemented into practice, our intervention could reduce rural/urban disparities in HPV-associated cancers in the US.
PROJECT SUMMARY – COMMUNITY OUTREACH AND ENGAGEMENT (COE)
The Ohio State University Comprehensive Cancer Center (OSUCCC) is a national and international leader in translational research, with a reputation for delivering high-quality patient care, effective outreach and education programs to residents of the state of Ohio - our catchment area (CA) - and beyond. The CA includes all 88 counties in Ohio, which have different populations (e.g., some that have poor outcomes) as well as urban, rural, and Appalachian communities. Electra PaskettCC, PhD, Deputy Director for Population Sciences and Community Outreach is Founding Director of the Center for Community Outreach and Engagement (CCOE). The CCOE team leads the Community Outreach and Engagement (COE) efforts and supports the OSUCCC mission to address the cancer burden throughout the CA. The CCOE is dedicated to facilitating COE by increasing cancer awareness, access to care and screening with an emphasis on fostering research in the CA. CCOE is co-led by Cheryl LeeTT, MD, who oversees the COE initiatives related to Clinical Engagement, interacting with the Clinical Trials Office to continually assess and modify the effectiveness of strategies to facilitate accrual of those historically not enrolled, as well as persons across the lifespan to clinical trials, and support the work of COE in connecting all populations to screening, outreach, and engagement services. Dr. Paskett works closely with the OSUCCC Senior Leadership Team (SLT) and research Program Leaders (PL) to cultivate interests in CA-focused research as well as working with the Government Relations team and key faculty across the OSUCCC to pursue policy initiatives that address the cancer burden. COE efforts and activities are developed and implemented with guidance from our Community Advisory Board (CAB), Community Champions, and Patient Champions across Research Programs. These entities provide ongoing feedback to the SLT through Dr. Paskett, as well as to the PLs, and program members through the COE Research Program liaisons. The high priority cancers for the OSUCCC were identified in conjunction with our CAB and community partners and include lung, breast, colorectal, prostate, liver, endometrial, cervical, and thyroid cancers, and leukemia. OSUCCC research and outreach efforts are ongoing to address these priority cancers and related risk factors via partnerships between the COE, Research Program members, and the community. To assess the impact of COE efforts, we use and update a logic model that includes activities, short-term, intermediate, and long-term outputs. The metrics of COE success include expanded reach; new initiatives and collaborations; and increases in screening services facilitated and clinical trial accrual. Over the last five years, we have had significant impact on patient navigation to screening, accrual of populations historically not enrolled to clinical trials, and fostering research to address the cancer burden in the CA. In the next five years, we propose to expand our patient navigation efforts, increase mobile screening capacity and support of research including emerging topics impacting the CA.
PROJECT SUMMARY
The overall goal of The Ohio State University (OSU) Accrual to Clinical Trials (ACTs) project is to increase the referral and accrual of participants to NCI’s National Clinical Trials Network (NCTN) prevention/control and treatment trials at the OSU Comprehensive Cancer Center (OSUCCC). This research is grounded in the socioecologic model developed by the Centers for Population Health and Health Disparities (Warnecke, et al. Am J Public Health 2008) and utilizes the theoretical model, Accrual to Clinical Trials (Paskett, et al. Clin Adv Hematol Oncol 2003). The OSUCCC serves the catchment area of the state of Ohio where over 95% of our patients with cancer reside. Working closely with the OSUCCC Center Community and Engagement (CCOE), OSUCCC National Outreach Network, community partner organizations, community providers in the OSUCCC referral area, James Hospital Network sites, NCI Community Oncology Research Program (NCORP) sites in Ohio, and the OSUCCC Clinical Trials Office, our goal will be accomplished by completing the following specific aims: 1) Conduct a baseline assessment of referral patterns and accrual of participants to clinical trials at OSUCCC by cancer disease group (breast, gastrointestinal, genitourinary, thoracic, hematologic, and others) and examine factors at the system (i.e., eligible clinical trial protocol, clinic context and culture), provider (trial discussed with patient), and patient level (agreed or refused participation) that influence referral and accrual (Phase I); 2) Implement a multi-level intervention in a stepped wedge design in referring practices in 9 counties with high counts of cancer cases in the OSUCCC catchment area using the Accrual to Clinical Trials framework (Paskett, et al. Clin Adv Hematol Oncol 2003), in Phase II. The intervention will include an outreach component, directed at community members and community practices, and an in-reach component, involving patients, providers, and the hospital system (at both referral centers and the OSUCCC) that directly addresses problems identified in Phase I; and 3) to evaluate the impact of the intervention on referral (primary outcome) and accrual patterns (secondary outcomes) in Phase III to clinical trials. Both qualitative and quantitative methods will be used. Dissemination of the key findings of our multi-level intervention is a high priority of this project.
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups, serves as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP) Research Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical and translational research as well as database studies – all of which address important questions relevant to cancer prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts clinically important quality of life studies that are embedded within cancer treatment trials. Alliance committees and protocols focus on all patients at risk for or diagnosed with cancer, and on building strong collegial relationships across all NCORP Community sites. The Alliance NCORP committee membership includes rich representation from both community-based and academic medical centers, as well as patient representatives thus generating research results relevant to cancer patients across the United States. The Alliance NCORP also emphasizes mentorship and training of junior investigators. Over this past grant cycle, i.e., since August 2014, the Alliance NCORP has published over 240 manuscripts and abstracts. This work has included practice-changing research in such areas as the prevention of chemotherapy-induced nausea and vomiting, the prevention of skeletal-related events from osseous metastases, the management of brain metastases, and the integration of patient-reported outcomes into cancer clinical trials. The Alliance NCORP conducts translational research that requires the collection of tumor tissue, premalignant tissue samples, blood, and other human biospecimens; and shares data and biospecimens for pooled analyses and other scientific collaborations. These biospecimens create an invaluable repository for understanding clinical observations from a mechanistic standpoint. The Alliance NCORP also collaborates broadly with other NCI- funded investigators and consortia, as well as with investigators supported through non-NCI sources. This practice-changing research and the scientific questions answered by the Alliance NCORP provide meaningful and innovative contributions to clinical and translational oncology, which can be conducted only within a publicly- funded research network.
ABSTRACT
Human papillomavirus (HPV) infection is the leading cause of over 36,000 new cancer cases of cervical, ano-
genital, and oropharyngeal cancers in the United States each year. While multi-valent vaccinations to prevent
HPV infections have been available since 2006, uptake of the vaccine is well below national Healthy
People 2030 targets (80% of adolescents at ages 13-15 years up-to-date with HPV vaccination). Adolescent
vaccination rates are especially low in rural areas (about 11% lower than in urban areas). Compared to urban
residents, rural residents have a higher incidence of HPV-related cancers and face unique barriers to HPV
vaccination, including limited access to providers, fewer vaccine reminders, longer travel time to clinics, and
less favorable societal norms about HPV vaccination. Moreover, rural adolescents are less likely than their
urban counterparts to receive a provider recommendation for the HPV vaccine. Rural healthcare teams are
often limited by a lack of systematic methods to identify and track eligible patients and/or their parents for
outreach. While much is known about clinic-based approaches to improve HPV vaccination among urban
residents, less is known about their effectiveness among rural residents, including rural Hispanic populations,
the fastest growing sub-population in rural settings. The proposed study is designed to address these
barriers by adapting and testing approaches to effectively communicate the importance of vaccination
to improve HPV vaccination rates for rural populations, and the sub-populations within (e.g. Hispanic
persons). Our study includes a randomized controlled trial of adapted reminders to address the needs of
diverse rural populations. We will create clinic systems to prompt vaccination for eligible children/adolescents
and deliver messages to parents/caregivers, whose mode and content is specifically tailored for rural and rural
Hispanic populations. Our study, Practice-based Approaches to Promote HPV Vaccination in the Safety Net
(PREVENT), incorporates formative patient- and clinic-informed research to design and evaluate an automated
data-driven reminder intervention using low-cost approaches (automated phone calls and text messages). We
will compare usual care to Automated Patient Reminders, and to a higher-intensity intervention arm using
automated messages plus linguistically and culturally tailored interventions to deliver live reminders,
Automated Plus Live Patient Reminders. PREVENT’s design and evaluation will involve tailoring message
mode and content for parents and caregivers of rural and ethnically diverse rural patients. This study will serve
as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among
diverse rural patients in the Mountain West. Our strong research team demonstrates successful partnerships
with primary care practices in rural populations. Once implemented into practice, our intervention could reduce
rural/urban disparities in HPV-associated cancers in the US.
PROJECT SUMMARY - COMMUNITY OUTREACH AND ENGAGEMENT (COE)
The Ohio State University Comprehensive Cancer Center (OSUCCC) is a national and international leader in
translational research, with a reputation for delivering high-quality patient care and effective outreach and
education programs to residents of the state of Ohio - our catchment area (CA) - and beyond. The CA includes
all 88 counties in Ohio, which have very diverse populations, with many underserved communities as well as
urban, rural and Appalachian communities. Electra Paskett, PhD, MSPH (CC) Associate Director for Population
Science and Community Outreach and Director of the Center for Cancer Health Equity (CCHE) leads the
Community Outreach and Engagement (COE) efforts for the OSUCCC. The CCHE is at the core of our COE
efforts supporting the OSUCCC mission to reduce cancer health disparities throughout the CA. The CCHE is co-
led by Darrell Gray II, MD, MPH, FACG (CC), who oversees the COE initiatives with the Clinical Trials Office to
improve the accrual of women and minorities to clinical trials. COE works in the CA to connect minority
populations to screening, outreach and engagement services. They also work with basic, clinical and population
science program leaders in the OSUCCC to cultivate interest in CA-focused research including working with the
Government Relations team and key faculty across the Center to pursue policy initiatives that address the cancer
burden. COE efforts are supported by two Community Advisory Boards (rural and urban) that inform the focus
and scope of CCHE activities and provide ongoing feedback to the OSUCCC leadership and Program leaders.
The high priority cancers for the OSUCCC include lung, breast, colorectal, prostate, endometrial, cervical cancer,
thyroid, and leukemia, as well as tobacco use, obesity and HPV vaccination. OSUCCC research and/or outreach
and engagement efforts are ongoing to address these priority areas, via partnerships between the COE,
OSUCCC research program members, and the community. To assess the impact of COE and OSUCCC efforts
we have developed a logic model that includes short-term metrics of COE success: expanded reach (community
members, patients); impact (services provided, time to diagnosis); collaborations (community partners,
researchers); initiatives (grants funded); and clinical trial accrual (especially of underrepresented populations);
and long-term metrics success including: reduced prevalence of risk factors and cancer rates, and longevity and
impact of community partnerships. Over the last five years, we have had significant impact on HPV vaccination
rates, accrual of minorities to clinical trials, breast cancer detection rates, navigation to screening and treatment,
implementing translation for non-English speaking patients, fostering research to address the cancer burden in
the CA. COE future plans focus on the priority cancers/risk behaviors of the OSUCCC as well as on 1) ensuring
adequate communication between the community and the OSUCCC researchers as it relates to addressing the
cancer burden in the catchment area and 2) a focus across the lifespan and expand to populations we are just
beginning to work with (Asian, pediatric, rural clinics, LGBTQ) in order to reduce the cancer burden in our CA.
PROJECT SUMMARY/ABSTRACT
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups, serves
as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP) Research
Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical and
translational research as well as database studies – all of which address important questions relevant to cancer
prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts clinically
important quality of life studies that are embedded within cancer treatment trials. It places special emphasis on
minority, underserved and older patients at risk for or diagnosed with cancer, and on building strong collegial
relationships with NCORP Community sites and Minority/Underserved Community sites. The Alliance NCORP
committee membership includes rich representation from both community-based and academic medical centers,
as well as patient advocates, thus generating research results relevant to cancer patients across the United
States. The Alliance NCORP also emphasizes mentorship and training of junior investigators. Over this past
grant cycle, i.e., since August 2014, the Alliance NCORP has published over 240 manuscripts and abstracts.
This work has included practice-changing research in such areas as the prevention of chemotherapy-induced
nausea and vomiting, the prevention of skeletal-related events from osseous metastases, the management of
brain metastases, and the integration of patient-reported outcomes into cancer clinical trials. The Alliance
NCORP conducts translational research that requires the collection of tumor tissue, premalignant tissue
samples, blood, and other human biospecimens; and shares data and biospecimens for pooled analyses and
other scientific collaborations. These biospecimens create an invaluable repository for understanding clinical
observations from a mechanistic standpoint. The Alliance NCORP also collaborates broadly with other NCI-
funded investigators and consortia, as well as with investigators supported through non-NCI sources. This
practice-changing research and the scientific questions answered by the Alliance NCORP provide meaningful
and innovative contributions to clinical and translational oncology, which can be conducted only within a publicly-
funded research network.
PROJECT SUMMARY/ABSTRACT
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups, serves
as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP) Research
Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical and
translational research as well as database studies – all of which address important questions relevant to cancer
prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts clinically
important quality of life studies that are embedded within cancer treatment trials. It places special emphasis on
minority, underserved and older patients at risk for or diagnosed with cancer, and on building strong collegial
relationships with NCORP Community sites and Minority/Underserved Community sites. The Alliance NCORP
committee membership includes rich representation from both community-based and academic medical centers,
as well as patient advocates, thus generating research results relevant to cancer patients across the United
States. The Alliance NCORP also emphasizes mentorship and training of junior investigators. Over this past
grant cycle, i.e., since August 2014, the Alliance NCORP has published over 240 manuscripts and abstracts.
This work has included practice-changing research in such areas as the prevention of chemotherapy-induced
nausea and vomiting, the prevention of skeletal-related events from osseous metastases, the management of
brain metastases, and the integration of patient-reported outcomes into cancer clinical trials. The Alliance
NCORP conducts translational research that requires the collection of tumor tissue, premalignant tissue
samples, blood, and other human biospecimens; and shares data and biospecimens for pooled analyses and
other scientific collaborations. These biospecimens create an invaluable repository for understanding clinical
observations from a mechanistic standpoint. The Alliance NCORP also collaborates broadly with other NCI-
funded investigators and consortia, as well as with investigators supported through non-NCI sources. This
practice-changing research and the scientific questions answered by the Alliance NCORP provide meaningful
and innovative contributions to clinical and translational oncology, which can be conducted only within a publicly-
funded research network.
PROJECT SUMMARY
The overall goal of The Ohio State University (OSU) Connecting Underrepresented Populations to Clinical Trials
(CUSP2CT) is to increase the referral and accrual of racial/ethnic minorities to NCI's National Clinical Trials
Network (NCTN) prevention/control and treatment trials at the OSU Comprehensive Cancer Center (OSUCCC).
This research is grounded in the socioecologic model developed by the Centers for Population Health and Health
Disparities (Warnecke, et al. Am J Public Health 2008) and utilizes the theoretical model, Accrual to Clinical
Trials (Paskett, et al. Clin Adv Hematol Oncol 2003). The OSUCCC serves the catchment area of the state of
Ohio where over 95% of our patients with cancer reside. Working closely with the OSUCCC Center for Cancer
Health Equity (CCHE), OSUCCC National Outreach Network, community partner organizations, community
providers in the OSUCCC referral area, James Hospital Network sites, NCI Community Oncology Research
Program (NCORP) sites in Ohio, and the OSUCCC Clinical Trials Office, our goal will be accomplished by
completing the following specific aims: 1) Conduct a baseline assessment of referral patterns and accrual of
racial and ethnic minorities to clinical trials at OSUCCC by cancer disease group (breast, gastrointestinal,
genitourinary, thoracic, hematologic, and others) and examine factors at the system (i.e., eligible clinical trial
protocol, clinic context and culture), provider (trial discussed with patient), and patient level (agreed or refused
participation) that influence referral and accrual (Phase I); 2) Implement a multi-level intervention in a stepped
wedge design in referring practices in 9 counties with high counts of minority cancer cases in the OSUCCC
catchment area using the Accrual to Clinical Trials framework (Paskett, et al. Clin Adv Hematol Oncol 2003), in
Phase II. The intervention will include an outreach component, directed at community members and community
practices, and an in-reach component, involving patients, providers, and the hospital system (at both referral
centers and the OSUCCC) that directly addresses problems identified in Phase I; and 3) to evaluate the impact
of the intervention on referral (primary outcome) and accrual patterns (secondary outcomes) in Phase III to
clinical trials. Both qualitative and quantitative methods will be used. Dissemination of the key findings of our
multi-level intervention is a high priority of this project.
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups, serves as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP) Research Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical and translational research as well as database studies – all of which address important questions relevant to cancer prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts clinically important quality of life studies that are embedded within cancer treatment trials. Alliance committees and protocols focus on all patients at risk for or diagnosed with cancer, and on building strong collegial relationships across all NCORP Community sites. The Alliance NCORP committee membership includes rich representation from both community-based and academic medical centers, as well as patient representatives thus generating research results relevant to cancer patients across the United States. The Alliance NCORP also emphasizes mentorship and training of junior investigators. Over this past grant cycle, i.e., since August 2014, the Alliance NCORP has published over 240 manuscripts and abstracts. This work has included practice-changing research in such areas as the prevention of chemotherapy-induced nausea and vomiting, the prevention of skeletal-related events from osseous metastases, the management of brain metastases, and the integration of patient-reported outcomes into cancer clinical trials. The Alliance NCORP conducts translational research that requires the collection of tumor tissue, premalignant tissue samples, blood, and other human biospecimens; and shares data and biospecimens for pooled analyses and other scientific collaborations. These biospecimens create an invaluable repository for understanding clinical observations from a mechanistic standpoint. The Alliance NCORP also collaborates broadly with other NCI- funded investigators and consortia, as well as with investigators supported through non-NCI sources. This practice-changing research and the scientific questions answered by the Alliance NCORP provide meaningful and innovative contributions to clinical and translational oncology, which can be conducted only within a publicly- funded research network.
ABSTRACT
Human papillomavirus (HPV) infection is the leading cause of over 36,000 new cancer cases of cervical, ano-
genital, and oropharyngeal cancers in the United States each year. While multi-valent vaccinations to prevent
HPV infections have been available since 2006, uptake of the vaccine is well below national Healthy
People 2030 targets (80% of adolescents at ages 13-15 years up-to-date with HPV vaccination). Adolescent
vaccination rates are especially low in rural areas (about 11% lower than in urban areas). Compared to urban
residents, rural residents have a higher incidence of HPV-related cancers and face unique barriers to HPV
vaccination, including limited access to providers, fewer vaccine reminders, longer travel time to clinics, and
less favorable societal norms about HPV vaccination. Moreover, rural adolescents are less likely than their
urban counterparts to receive a provider recommendation for the HPV vaccine. Rural healthcare teams are
often limited by a lack of systematic methods to identify and track eligible patients and/or their parents for
outreach. While much is known about clinic-based approaches to improve HPV vaccination among urban
residents, less is known about their effectiveness among rural residents, including rural Hispanic populations,
the fastest growing sub-population in rural settings. The proposed study is designed to address these
barriers by adapting and testing approaches to effectively communicate the importance of vaccination
to improve HPV vaccination rates for rural populations, and the sub-populations within (e.g. Hispanic
persons). Our study includes a randomized controlled trial of adapted reminders to address the needs of
diverse rural populations. We will create clinic systems to prompt vaccination for eligible children/adolescents
and deliver messages to parents/caregivers, whose mode and content is specifically tailored for rural and rural
Hispanic populations. Our study, Practice-based Approaches to Promote HPV Vaccination in the Safety Net
(PREVENT), incorporates formative patient- and clinic-informed research to design and evaluate an automated
data-driven reminder intervention using low-cost approaches (automated phone calls and text messages). We
will compare usual care to Automated Patient Reminders, and to a higher-intensity intervention arm using
automated messages plus linguistically and culturally tailored interventions to deliver live reminders,
Automated Plus Live Patient Reminders. PREVENT’s design and evaluation will involve tailoring message
mode and content for parents and caregivers of rural and ethnically diverse rural patients. This study will serve
as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among
diverse rural patients in the Mountain West. Our strong research team demonstrates successful partnerships
with primary care practices in rural populations. Once implemented into practice, our intervention could reduce
rural/urban disparities in HPV-associated cancers in the US.
PROJECT SUMMARY - COMMUNITY OUTREACH AND ENGAGEMENT (COE)
The Ohio State University Comprehensive Cancer Center (OSUCCC) is a national and international leader in
translational research, with a reputation for delivering high-quality patient care and effective outreach and
education programs to residents of the state of Ohio - our catchment area (CA) - and beyond. The CA includes
all 88 counties in Ohio, which have very diverse populations, with many underserved communities as well as
urban, rural and Appalachian communities. Electra Paskett, PhD, MSPH (CC) Associate Director for Population
Science and Community Outreach and Director of the Center for Cancer Health Equity (CCHE) leads the
Community Outreach and Engagement (COE) efforts for the OSUCCC. The CCHE is at the core of our COE
efforts supporting the OSUCCC mission to reduce cancer health disparities throughout the CA. The CCHE is co-
led by Darrell Gray II, MD, MPH, FACG (CC), who oversees the COE initiatives with the Clinical Trials Office to
improve the accrual of women and minorities to clinical trials. COE works in the CA to connect minority
populations to screening, outreach and engagement services. They also work with basic, clinical and population
science program leaders in the OSUCCC to cultivate interest in CA-focused research including working with the
Government Relations team and key faculty across the Center to pursue policy initiatives that address the cancer
burden. COE efforts are supported by two Community Advisory Boards (rural and urban) that inform the focus
and scope of CCHE activities and provide ongoing feedback to the OSUCCC leadership and Program leaders.
The high priority cancers for the OSUCCC include lung, breast, colorectal, prostate, endometrial, cervical cancer,
thyroid, and leukemia, as well as tobacco use, obesity and HPV vaccination. OSUCCC research and/or outreach
and engagement efforts are ongoing to address these priority areas, via partnerships between the COE,
OSUCCC research program members, and the community. To assess the impact of COE and OSUCCC efforts
we have developed a logic model that includes short-term metrics of COE success: expanded reach (community
members, patients); impact (services provided, time to diagnosis); collaborations (community partners,
researchers); initiatives (grants funded); and clinical trial accrual (especially of underrepresented populations);
and long-term metrics success including: reduced prevalence of risk factors and cancer rates, and longevity and
impact of community partnerships. Over the last five years, we have had significant impact on HPV vaccination
rates, accrual of minorities to clinical trials, breast cancer detection rates, navigation to screening and treatment,
implementing translation for non-English speaking patients, fostering research to address the cancer burden in
the CA. COE future plans focus on the priority cancers/risk behaviors of the OSUCCC as well as on 1) ensuring
adequate communication between the community and the OSUCCC researchers as it relates to addressing the
cancer burden in the catchment area and 2) a focus across the lifespan and expand to populations we are just
beginning to work with (Asian, pediatric, rural clinics, LGBTQ) in order to reduce the cancer burden in our CA.
PROJECT SUMMARY/ABSTRACT
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups, serves
as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP) Research
Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical and
translational research as well as database studies – all of which address important questions relevant to cancer
prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts clinically
important quality of life studies that are embedded within cancer treatment trials. It places special emphasis on
minority, underserved and older patients at risk for or diagnosed with cancer, and on building strong collegial
relationships with NCORP Community sites and Minority/Underserved Community sites. The Alliance NCORP
committee membership includes rich representation from both community-based and academic medical centers,
as well as patient advocates, thus generating research results relevant to cancer patients across the United
States. The Alliance NCORP also emphasizes mentorship and training of junior investigators. Over this past
grant cycle, i.e., since August 2014, the Alliance NCORP has published over 240 manuscripts and abstracts.
This work has included practice-changing research in such areas as the prevention of chemotherapy-induced
nausea and vomiting, the prevention of skeletal-related events from osseous metastases, the management of
brain metastases, and the integration of patient-reported outcomes into cancer clinical trials. The Alliance
NCORP conducts translational research that requires the collection of tumor tissue, premalignant tissue
samples, blood, and other human biospecimens; and shares data and biospecimens for pooled analyses and
other scientific collaborations. These biospecimens create an invaluable repository for understanding clinical
observations from a mechanistic standpoint. The Alliance NCORP also collaborates broadly with other NCI-
funded investigators and consortia, as well as with investigators supported through non-NCI sources. This
practice-changing research and the scientific questions answered by the Alliance NCORP provide meaningful
and innovative contributions to clinical and translational oncology, which can be conducted only within a publicly-
funded research network.
PROJECT SUMMARY
The overall goal of The Ohio State University (OSU) Connecting Underrepresented Populations to Clinical Trials
(CUSP2CT) is to increase the referral and accrual of racial/ethnic minorities to NCI's National Clinical Trials
Network (NCTN) prevention/control and treatment trials at the OSU Comprehensive Cancer Center (OSUCCC).
This research is grounded in the socioecologic model developed by the Centers for Population Health and Health
Disparities (Warnecke, et al. Am J Public Health 2008) and utilizes the theoretical model, Accrual to Clinical
Trials (Paskett, et al. Clin Adv Hematol Oncol 2003). The OSUCCC serves the catchment area of the state of
Ohio where over 95% of our patients with cancer reside. Working closely with the OSUCCC Center for Cancer
Health Equity (CCHE), OSUCCC National Outreach Network, community partner organizations, community
providers in the OSUCCC referral area, James Hospital Network sites, NCI Community Oncology Research
Program (NCORP) sites in Ohio, and the OSUCCC Clinical Trials Office, our goal will be accomplished by
completing the following specific aims: 1) Conduct a baseline assessment of referral patterns and accrual of
racial and ethnic minorities to clinical trials at OSUCCC by cancer disease group (breast, gastrointestinal,
genitourinary, thoracic, hematologic, and others) and examine factors at the system (i.e., eligible clinical trial
protocol, clinic context and culture), provider (trial discussed with patient), and patient level (agreed or refused
participation) that influence referral and accrual (Phase I); 2) Implement a multi-level intervention in a stepped
wedge design in referring practices in 9 counties with high counts of minority cancer cases in the OSUCCC
catchment area using the Accrual to Clinical Trials framework (Paskett, et al. Clin Adv Hematol Oncol 2003), in
Phase II. The intervention will include an outreach component, directed at community members and community
practices, and an in-reach component, involving patients, providers, and the hospital system (at both referral
centers and the OSUCCC) that directly addresses problems identified in Phase I; and 3) to evaluate the impact
of the intervention on referral (primary outcome) and accrual patterns (secondary outcomes) in Phase III to
clinical trials. Both qualitative and quantitative methods will be used. Dissemination of the key findings of our
multi-level intervention is a high priority of this project.
SUMMARY/ABSTRACT
There are 16 million cancer survivors in the United States, and approximately 60% are age 65 years and over.
By 2040, it is estimated that the number of cancer survivors will grow to 26 million with 73% age 65 and older
and almost 50% age 75 and older. Despite this so-called silver tsunami of older cancer survivors, there are
significant knowledge gaps regarding how cancer and cancer treatment impacts the aging process. There is
also a growing consensus regarding the need for studies of cancer in older adults because of the prevalence of
comorbidities, functional losses, cognitive impairment, and frailty, and particularly for those age ≥ 75 for whom
there are virtually no data. Studies are needed to better understand how cancer and its treatment interact with
underlying vulnerabilities, which in turn impacts the feasibility, safety, and efficacy of interventions in this
population. The Life and Longevity After Cancer (LILAC) project is a cancer survivor cohort embedded within
the Women’s Health Initiative to support studies of cancer survivorship in an aging population. During the initial
funding period, we developed the LILAC cohort of 13,453 WHI cancer survivors who were diagnosed with one
of eight LILAC designated cancers: invasive breast, colorectal, endometrial, melanoma, leukemia, lung,
lymphoma, melanoma, or ovarian. We collected information on first course of treatment, clinical and patient
reported outcomes, as well as archival tissue from 4351 solid tumors. With a minimum of 20 years of data on
these women and a current age-range of 70 to101 years, the LILAC population is poised to provide key
information on cancer and aging to advance our cancer and aging research agenda. To accomplish this we
propose to enhance the LILAC resource through several mechanisms designed to support analyses of
emerging questions. Specifically, we propose: 1) To fill critical gaps in knowledge regarding the self-reported
physical, mental and social health of older female cancer survivors by continuing to enroll newly diagnosed
survivors (N=2685) and follow the LILAC cohort; 2) To develop the analytic framework to assess trajectories of
aging, including an accelerated aging phenotype in the WHI/LILAC database; 3) To establish cohorts of age-
matched WHI participants with similar data who have remained cancer free, to help us understand the
diagnosis of cancer and its treatment on the trajectories of aging, the accelerated aging phenotype and age-
related comorbidities; 4) To obtain performance-based measures of physical function and new post-treatment
blood samples to assess potential biomarkers of accelerated aging; and 5) To maximize the use and impact of
this resource. Given the aging of the US population, the increase in the number of cancer survivors and the
association between cancer and aging, these strategic and timely investments in the LILAC infrastructure will
help to fill many of these critical research gaps.
Alliance NCORP Research Base
Project Summary/Abstract
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups,
serves as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP)
Research Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical
and translational research as well as database studies – all of which address important questions relevant to
cancer prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts
clinically important quality of life studies that are embedded within cancer treatment trials. It places special
emphasis on minority, underserved and older patients at risk for or diagnosed with cancer, and on building
strong collegial relationships with NCORP Community sites and Minority/Underserved Community sites. The
Alliance NCORP committee membership includes rich representation from both community-based and
academic medical centers, as well as patient advocates, thus generating research results relevant to cancer
patients across the United States. The Alliance NCORP also emphasizes mentorship and training of junior
investigators. Over this past grant cycle, i.e., since August 2014, the Alliance NCORP has published 148
manuscripts and abstracts. This work has included practice-changing research in such areas as the
prevention of chemotherapy-induced nausea and vomiting, the prevention of skeletal-related events from
osseous metastases, the management of brain metastases, and the integration of patient-reported outcomes
into cancer clinical trials. The Alliance NCORP conducts translational research that requires the collection of
tumor tissue, premalignant tissue samples, blood, and other human biospecimens; and shares data and
biospecimens for pooled analyses and other scientific collaborations. These biospecimens create an
invaluable repository for understanding clinical observations from a mechanistic standpoint. The Alliance
NCORP also collaborates broadly with other NCI-funded investigators and consortia, as well as with
investigators supported through non-NCI sources. This practice-changing research and the scientific
questions answered by the Alliance NCORP provide meaningful and innovative contributions to clinical and
translational oncology, which can be conducted only within a publicly-funded research network.
PROJECT SUMMARY - ADMINISTRATIVE CORE (AC)
The overall goal of the Administrative Core (AC) is to provide a structure to facilitate effective interactions toward
accomplishment of the aims of this Program Project. To accomplish this goal, the AC will be structured into a
Steering Committee and a Project Management Team. These groups will work together to accomplish the
following specific aims: 1) Provide research direction by setting the research agenda focused on addressing
cervical cancer disparities in Appalachia and promoting transdisciplinary research; 2) Ensure operational
efficiency for all components of the Program by providing centralized grant administration, information
dissemination, budget data processing, and seamless exchange of information and services; and 3) Promote
integration of the Projects and Cores (Survey and Data Collection, Intervention and Consortium, and
Biostatistics and Evaluation) to promote interaction among the four Universities, the investigators, the
Appalachian communities, the participating community clinics/health systems; and relevant external entities. The
proposed AC builds upon the successful experience of the structure of the Appalachian Community Cancer
Network (P30 CA016058), in which the Multiple Principal Investigators (MPIs) worked together for over 10 years.
The proposed structure will be led by a Headquarters unit located at The Ohio State University and be directed
by MPIs, Drs. Paskett, Anderson, Dignan and Kennedy. The members of this team are well acquainted and
have a track record of conducting research projects together, as well as each has substantial experience with
conducting community based research in Appalachia. We have designed an organizational and administrative
structure that defines and preserves clear responsibilities and facilitates interactive dependence among projects
and cores. The MPIs will be responsible for day-to-day oversight of the important milestones, and integration
among all Program components. The AC will also oversee the operation of the Steering Committee, an External
Scientific Advisory Committee, comprised of four scientists from outside institutions, and will also work with the
Intervention and Consortium Core to facilitate input from and meetings with members of the Community Advisory
Board and the Clinical Partners, assuring Community-Based Participatory Research in all the aspects of the
Program, and be responsible for regular meetings of the Data and Safety Monitoring Board, in conjunction with
the Biostatistics and Evaluation Core. The Program also has two consultants – Drs. Mack Ruffin and Jaimie
Ostroff – to advise on clinical issues and Implementation Science, respectively. Lastly, the AC will ensure that
all components of the Program work seamlessly together to accomplish the Overall and specific project goals of
the Program Project and that the two conceptual models which underlie the research – the Multi-Level Model for
Addressing Health Disparities (for intervention and assessment) and the Proctor Implementation Framework (for
implementation and evaluation of the interventions) are fully embraced and integrated.
Alliance NCORP Research Base
Project Summary/Abstract
The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups,
serves as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP)
Research Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical
and translational research as well as database studies – all of which address important questions relevant to
cancer prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts
clinically important quality of life studies that are embedded within cancer treatment trials. It places special
emphasis on minority, underserved and older patients at risk for or diagnosed with cancer, and on building
strong collegial relationships with NCORP Community sites and Minority/Underserved Community sites. The
Alliance NCORP committee membership includes rich representation from both community-based and
academic medical centers, as well as patient advocates, thus generating research results relevant to cancer
patients across the United States. The Alliance NCORP also emphasizes mentorship and training of junior
investigators. Over this past grant cycle, i.e., since August 2014, the Alliance NCORP has published 148
manuscripts and abstracts. This work has included practice-changing research in such areas as the
prevention of chemotherapy-induced nausea and vomiting, the prevention of skeletal-related events from
osseous metastases, the management of brain metastases, and the integration of patient-reported outcomes
into cancer clinical trials. The Alliance NCORP conducts translational research that requires the collection of
tumor tissue, premalignant tissue samples, blood, and other human biospecimens; and shares data and
biospecimens for pooled analyses and other scientific collaborations. These biospecimens create an
invaluable repository for understanding clinical observations from a mechanistic standpoint. The Alliance
NCORP also collaborates broadly with other NCI-funded investigators and consortia, as well as with
investigators supported through non-NCI sources. This practice-changing research and the scientific
questions answered by the Alliance NCORP provide meaningful and innovative contributions to clinical and
translational oncology, which can be conducted only within a publicly-funded research network.
ABSTRACT
Human papillomavirus (HPV) infection is the leading cause of over 36,000 new cancer cases of cervical, ano-
genital, and oropharyngeal cancers in the United States each year. While multi-valent vaccinations to prevent
HPV infections have been available since 2006, uptake of the vaccine is well below national Healthy
People 2030 targets (80% of adolescents at ages 13-15 years up-to-date with HPV vaccination). Adolescent
vaccination rates are especially low in rural areas (about 11% lower than in urban areas). Compared to urban
residents, rural residents have a higher incidence of HPV-related cancers and face unique barriers to HPV
vaccination, including limited access to providers, fewer vaccine reminders, longer travel time to clinics, and
less favorable societal norms about HPV vaccination. Moreover, rural adolescents are less likely than their
urban counterparts to receive a provider recommendation for the HPV vaccine. Rural healthcare teams are
often limited by a lack of systematic methods to identify and track eligible patients and/or their parents for
outreach. While much is known about clinic-based approaches to improve HPV vaccination among urban
residents, less is known about their effectiveness among rural residents, including rural Hispanic populations,
the fastest growing sub-population in rural settings. The proposed study is designed to address these
barriers by adapting and testing approaches to effectively communicate the importance of vaccination
to improve HPV vaccination rates for rural populations, and the sub-populations within (e.g. Hispanic
persons). Our study includes a randomized controlled trial of adapted reminders to address the needs of
diverse rural populations. We will create clinic systems to prompt vaccination for eligible children/adolescents
and deliver messages to parents/caregivers, whose mode and content is specifically tailored for rural and rural
Hispanic populations. Our study, Practice-based Approaches to Promote HPV Vaccination in the Safety Net
(PREVENT), incorporates formative patient- and clinic-informed research to design and evaluate an automated
data-driven reminder intervention using low-cost approaches (automated phone calls and text messages). We
will compare usual care to Automated Patient Reminders, and to a higher-intensity intervention arm using
automated messages plus linguistically and culturally tailored interventions to deliver live reminders,
Automated Plus Live Patient Reminders. PREVENT’s design and evaluation will involve tailoring message
mode and content for parents and caregivers of rural and ethnically diverse rural patients. This study will serve
as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among
diverse rural patients in the Mountain West. Our strong research team demonstrates successful partnerships
with primary care practices in rural populations. Once implemented into practice, our intervention could reduce
rural/urban disparities in HPV-associated cancers in the US.
PROJECT SUMMARY – CANCER CONTROL (CC)
The Cancer Control (CC) Program at The Ohio State University Comprehensive Cancer Center (OSUCCC), led
by Electra Paskett, PhD, and Theodore Wagener, PhD, has 53 members from 21 Departments and 7 OSU
Colleges (Arts & Sciences, Dentistry, Education & Human Ecology, Law, Medicine, Nursing, and Public Health).
The overall goal of the CC Program is to conduct research to reduce the incidence, mortality and morbidity of
cancer in our catchment area, the state of Ohio, and beyond. The CC Program conducts research across the
cancer control continuum, from etiology through survivorship, and across the lifespan. Crosscutting themes unite
the aims of the program and include policy and underserved/minority populations, with a focus on the priority
cancers of the OSUCCC. Our research also capitalizes on our members’ strengths, such as epidemiology,
biology and behavior, and includes trans-disciplinary research teams to address research aims. The Specific
Aims of the CC Program are to: 1) Identify molecular, genetic, and behavioral factors related to cancer incidence
and mortality at a population level; 2) Develop and test behavioral interventions that prevent cancer development
or facilitate early detection; and, 3) Assess and intervene on issues of cancer survivorship (including active
cancer patients and survivors). CC Program members published 1,028 cancer-relevant manuscripts between
12/01/14 and 11/30/19. Of these, 17% were intra-programmatic (multiple authors from CC Program), 22% were
inter-programmatic (authors from multiple OSUCCC Programs), and 74% were multi-institutional (authors from
both CC and another institution). The total collaborative publications is 87%. CC Program funding stands at
$7.7M in overall direct, cancer-focused funding, of which $6.7M is peer-reviewed, including $6.2M direct funding
from NIH ($3.6M from NCI). Over the last 5 years, CC Program members have accrued 21,450 participants to
trials; 4,807 to non-therapeutic/interventional trials and 16,643 to non-therapeutic/ non-interventional trials.
Future plans for the CC Program include increasing research in: 1) molecular and genetic epidemiology; 2)
patient outcomes; 3) survivorship, including the effects of immunotherapy on patient outcomes through
collaborations with the new OSUCCC Pelotonia Institute for Immuno-Oncology; and 4) tobacco use and related
health-effects through the new OSUCCC Center for Tobacco Research.
PROJECT SUMMARY
Survivors of childhood and young adult cancer have a substantial risk of developing a second cancer, including
Human Papillomavirus (HPV)-related cancers. Female childhood cancer survivors have 40% relative excess
and male survivors have 150% relative excess of HPV-associated malignancies compared to the general
population. Since 2009, the Children’s Oncology Group guidelines have recommended HPV vaccination to
reduce the risk for HPV-related cancers for all eligible childhood cancer survivors. The limited research to date
demonstrates low uptake and completion of the 3-dose HPV vaccination series among survivors of childhood
cancer. However, these studies have been focused on self-report assessments at single institutions among
female survivors. Evaluating HPV vaccination among survivors in Utah is of great public health importance as
Utah’s 3-dose HPV vaccine series completion is among the lowest in the nation for both female teens (49th
state) and male teens (43rd state). As many survivors of childhood cancer do not expeditiously transition back
to primary care at the end of their cancer treatment, it is likely that their rates of HPV vaccination completion
are even lower than the general population. We propose the first statewide assessment of HPV vaccination
among both female and male childhood cancer survivors and an age and sex-matched general population
comparison group from a largely rural state with low rates of HPV vaccination over a nine year time period
(2006-2015). Building on two statewide resources 1) the Utah Population Database, which is linked to clinical
data from Intermountain Healthcare, including Primary Children’s Hospital, where the majority of pediatric
cancers in Utah are treated, and the 2) Utah Statewide Immunization Information System, we will conduct the
first statewide evaluation of the rate of HPV vaccination among a sample of 1,863 childhood cancer survivors.
Using UPDB allows us to generate an age and sex-matched general population comparison group without
cancer to compare to the survivors. Our outcomes of interest are HPV vaccination initiation, receipt of 2 doses,
3-dose completion, and missed opportunities (defined as a healthcare visit when a patient received at least
one immunization, but not a HPV vaccine dose). In the first aim, we will compare HPV vaccination among
survivors of childhood cancer with the general population. In the second aim, we will identify high-risk groups of
survivors of childhood cancer, such as survivors who are Hispanic, publically-insured, rural, and living in a
health professional shortage area, who may be more likely to forego the HPV vaccine. At the end of the study,
we will have identified whether both male and female childhood cancer survivors are less likely to get the HPV
vaccine compared to adolescents and young adults without cancer. Also, we will establish at statewide level
whether certain childhood cancer survivors (e.g., Hispanic) are more likely to miss getting the HPV vaccine,
which is essential information to developing cancer prevention strategies for this growing population.
PROJECT SUMMARY
Survivors of childhood and young adult cancer have a substantial risk of developing a second cancer, including
Human Papillomavirus (HPV)-related cancers. Female childhood cancer survivors have 40% relative excess
and male survivors have 150% relative excess of HPV-associated malignancies compared to the general
population. Since 2009, the Children’s Oncology Group guidelines have recommended HPV vaccination to
reduce the risk for HPV-related cancers for all eligible childhood cancer survivors. The limited research to date
demonstrates low uptake and completion of the 3-dose HPV vaccination series among survivors of childhood
cancer. However, these studies have been focused on self-report assessments at single institutions among
female survivors. Evaluating HPV vaccination among survivors in Utah is of great public health importance as
Utah’s 3-dose HPV vaccine series completion is among the lowest in the nation for both female teens (49th
state) and male teens (43rd state). As many survivors of childhood cancer do not expeditiously transition back
to primary care at the end of their cancer treatment, it is likely that their rates of HPV vaccination completion
are even lower than the general population. We propose the first statewide assessment of HPV vaccination
among both female and male childhood cancer survivors and an age and sex-matched general population
comparison group from a largely rural state with low rates of HPV vaccination over a nine year time period
(2006-2015). Building on two statewide resources 1) the Utah Population Database, which is linked to clinical
data from Intermountain Healthcare, including Primary Children’s Hospital, where the majority of pediatric
cancers in Utah are treated, and the 2) Utah Statewide Immunization Information System, we will conduct the
first statewide evaluation of the rate of HPV vaccination among a sample of 1,863 childhood cancer survivors.
Using UPDB allows us to generate an age and sex-matched general population comparison group without
cancer to compare to the survivors. Our outcomes of interest are HPV vaccination initiation, receipt of 2 doses,
3-dose completion, and missed opportunities (defined as a healthcare visit when a patient received at least
one immunization, but not a HPV vaccine dose). In the first aim, we will compare HPV vaccination among
survivors of childhood cancer with the general population. In the second aim, we will identify high-risk groups of
survivors of childhood cancer, such as survivors who are Hispanic, publically-insured, rural, and living in a
health professional shortage area, who may be more likely to forego the HPV vaccine. At the end of the study,
we will have identified whether both male and female childhood cancer survivors are less likely to get the HPV
vaccine compared to adolescents and young adults without cancer. Also, we will establish at statewide level
whether certain childhood cancer survivors (e.g., Hispanic) are more likely to miss getting the HPV vaccine,
which is essential information to developing cancer prevention strategies for this growing population.
DESCRIPTION (provided by applicant): Adolescent marijuana use is a prominent public health concern. Indeed, exposure to marijuana during adolescence is correlated with drug abuse and addiction in adulthood and predicts future cocaine abuse. Changing national attitudes on marijuana use and the resultant push for the reform of marijuana laws (23 states and the District of Columbia currently have legalized marijuana in some form) highlight a need to examine the long-term neurobiological consequences of cannabinoid exposure. I have collected preliminary data showing that adolescent exposure to a cannabinoid agonist disrupts the experience of cocaine reward in adulthood and results in cocaine-induced conditioned place aversion. These data confirm the work of others showing that cannabinoid exposure in adolescence disturbs normal brain development and produces lasting effects on behavior. In this study, we intend to utilize cutting-edge electrochemical and optogenetic techniques to investigate the effects of cannabinoid exposure in adolescence on cocaine experience and reinforcement in adulthood. Specific aim 1 utilizes pharmacological manipulations to determine if cannabinoid exposure in adolescence exerts its effects on adult cocaine experience through actions at CB1 receptors. In the same animals we will employ the electrochemical technique fast-scan cyclic voltammetry to measure whether cannabinoid exposure during adolescence changes subsecond dopamine release evoked by cocaine and cocaine-associated contextual cues and assess how cannabinoid exposure affects the initiation and escalation of cocaine self-administration. Specific aim 2 uses optogenetic tools to test whether cannabinoids alter cocaine experience through disruption of dopaminergic function. Altogether these experiments will provide novel information concerning the neural mechanisms through which cannabinoid exposure in adolescence disturbs brain development and influences cocaine reward and reinforcement in adulthood.
DESCRIPTION (provided by applicant): Adolescent marijuana use is a prominent public health concern. Indeed, exposure to marijuana during adolescence is correlated with drug abuse and addiction in adulthood and predicts future cocaine abuse. Changing national attitudes on marijuana use and the resultant push for the reform of marijuana laws (23 states and the District of Columbia currently have legalized marijuana in some form) highlight a need to examine the long-term neurobiological consequences of cannabinoid exposure. I have collected preliminary data showing that adolescent exposure to a cannabinoid agonist disrupts the experience of cocaine reward in adulthood and results in cocaine-induced conditioned place aversion. These data confirm the work of others showing that cannabinoid exposure in adolescence disturbs normal brain development and produces lasting effects on behavior. In this study, we intend to utilize cutting-edge electrochemical and optogenetic techniques to investigate the effects of cannabinoid exposure in adolescence on cocaine experience and reinforcement in adulthood. Specific aim 1 utilizes pharmacological manipulations to determine if cannabinoid exposure in adolescence exerts its effects on adult cocaine experience through actions at CB1 receptors. In the same animals we will employ the electrochemical technique fast-scan cyclic voltammetry to measure whether cannabinoid exposure during adolescence changes subsecond dopamine release evoked by cocaine and cocaine-associated contextual cues and assess how cannabinoid exposure affects the initiation and escalation of cocaine self-administration. Specific aim 2 uses optogenetic tools to test whether cannabinoids alter cocaine experience through disruption of dopaminergic function. Altogether these experiments will provide novel information concerning the neural mechanisms through which cannabinoid exposure in adolescence disturbs brain development and influences cocaine reward and reinforcement in adulthood.
DESCRIPTION (provided by applicant): While individual- and provider-level factors for low Human Papillomavirus (HPV) vaccination rates in the United States (U.S.) have been well examined, the role of community-level geographic factors in HPV vaccine initiation and 3-dose completion in the U.S. is unknown. Geographic and neighborhood factors could influence vaccination through several pathways linked to material resources of the neighborhood, availability and ease of access to health-care facilities and services, social capital (e.g., socia contagion, similar norms of behavior), and residential segregation. Using data from the National Immunization Survey-Teen (NIS-Teen), an annual survey conducted by the Centers for Disease Control and Prevention to monitor vaccination uptake in the U.S., associations between HPV vaccination among adolescent girls and boys and community-level geographic factors including poverty, rural/urban residence, and racial composition will be examined. Zip code and county- level geographic identifiers are not available in the public-use NIS-Teen datasets, and therefore these geographic identifiers will be accessed and linked via the restricted use NIS-Teen files to provide a novel examination of geographic factors' role in HPV vaccination. First, we will identify
community-level geographic factors that are independent predictors of both vaccine initiation and series completion, among U.S. teen girls and boys separately. Next, we will investigate how geographic and community level socioeconomic factors impact and interact with individual level factors associated with HPV vaccine initiation and completion. This will be the first study to provide much needed information on the influence of community-level geographic factors on HPV vaccine initiation and completion among a nationally representative sample of adolescents in the U.S. Given the low rates of HPV vaccination in the U.S., the results from the proposed study will help inform public health practice and the development of geographically targeted interventions to improve HPV vaccination in the United States.
DESCRIPTION (provided by applicant): Adolescent marijuana use is a prominent public health concern. Indeed, exposure to marijuana during adolescence is correlated with drug abuse and addiction in adulthood and predicts future cocaine abuse. Changing national attitudes on marijuana use and the resultant push for the reform of marijuana laws (23 states and the District of Columbia currently have legalized marijuana in some form) highlight a need to examine the long-term neurobiological consequences of cannabinoid exposure. I have collected preliminary data showing that adolescent exposure to a cannabinoid agonist disrupts the experience of cocaine reward in adulthood and results in cocaine-induced conditioned place aversion. These data confirm the work of others showing that cannabinoid exposure in adolescence disturbs normal brain development and produces lasting effects on behavior. In this study, we intend to utilize cutting-edge electrochemical and optogenetic techniques to investigate the effects of cannabinoid exposure in adolescence on cocaine experience and reinforcement in adulthood. Specific aim 1 utilizes pharmacological manipulations to determine if cannabinoid exposure in adolescence exerts its effects on adult cocaine experience through actions at CB1 receptors. In the same animals we will employ the electrochemical technique fast-scan cyclic voltammetry to measure whether cannabinoid exposure during adolescence changes subsecond dopamine release evoked by cocaine and cocaine-associated contextual cues and assess how cannabinoid exposure affects the initiation and escalation of cocaine self-administration. Specific aim 2 uses optogenetic tools to test whether cannabinoids alter cocaine experience through disruption of dopaminergic function. Altogether these experiments will provide novel information concerning the neural mechanisms through which cannabinoid exposure in adolescence disturbs brain development and influences cocaine reward and reinforcement in adulthood.
DESCRIPTION (provided by applicant): While individual- and provider-level factors for low Human Papillomavirus (HPV) vaccination rates in the United States (U.S.) have been well examined, the role of community-level geographic factors in HPV vaccine initiation and 3-dose completion in the U.S. is unknown. Geographic and neighborhood factors could influence vaccination through several pathways linked to material resources of the neighborhood, availability and ease of access to health-care facilities and services, social capital (e.g., socia contagion, similar norms of behavior), and residential segregation. Using data from the National Immunization Survey-Teen (NIS-Teen), an annual survey conducted by the Centers for Disease Control and Prevention to monitor vaccination uptake in the U.S., associations between HPV vaccination among adolescent girls and boys and community-level geographic factors including poverty, rural/urban residence, and racial composition will be examined. Zip code and county- level geographic identifiers are not available in the public-use NIS-Teen datasets, and therefore these geographic identifiers will be accessed and linked via the restricted use NIS-Teen files to provide a novel examination of geographic factors' role in HPV vaccination. First, we will identify
community-level geographic factors that are independent predictors of both vaccine initiation and series completion, among U.S. teen girls and boys separately. Next, we will investigate how geographic and community level socioeconomic factors impact and interact with individual level factors associated with HPV vaccine initiation and completion. This will be the first study to provide much needed information on the influence of community-level geographic factors on HPV vaccine initiation and completion among a nationally representative sample of adolescents in the U.S. Given the low rates of HPV vaccination in the U.S., the results from the proposed study will help inform public health practice and the development of geographically targeted interventions to improve HPV vaccination in the United States.