Multiple Principal Investigators: Maria D. Thomson, Ph.D. & Vanessa B. Sheppard, Ph.D.

The objective of this research project is to establish a research registry dedicated to collecting information on key cancer risk reducing behaviors and stimulate dedicated cancer prevention and control research among members of Massey Comprehensive Cancer Center and other NCI-Designated Centers.

Where you live can have important influences on the types of risks that are important to you and your health. For example, we know that some areas in Virginia have higher than expected rates of cancer. The information that we gather in this research will allow us to better understand which behaviors and environmental factors may be contributing to high cancer rates in these areas. From this information, we can develop better cancer prevention and control information, programs and services.

Multiple Principal Investigator: Jessica G. LaRose, PhD

Funding Source: National Cancer Institute R01CA270111

Project Summary: Survivors of adolescent and young adult cancers (AYAs) are a vulnerable and underserved subgroup of survivors at increased risk for long-term health effects, including obesity, diabetes, cardiovascular disease, additional cancers, and frailty. Furthermore, over half of AYAs already have overweight or obesity and obesogenic lifestyle behaviors are common among AYAs, which exacerbates their cardiometabolic risk. Given that obesity is associated with poorer outcomes in cancer survivors, there is a critical need for weight management interventions—yet, no weight loss interventions have been developed to meet the unique needs of AYAs. Extant research, including our own preliminary data, indicate that AYAs prefer tailored interventions (both with respect to developmental stage and cancer context) that are delivered remotely via website or app. Thus, we propose to develop a 6-month mHealth weight management intervention designed specifically for AYA cancer survivors and test its efficacy in a randomized controlled trial. The intervention will be rooted in self-determination theory in order to bolster intrinsic motivation for health behavior change by enhancing perceived competence, relatedness, and autonomy. It will include evidence-based behavioral weight loss strategies adapted for AYA survivors (e.g., simplified dietary self-monitoring, adaptive goal-setting, tailored feedback on progress) as well as personalized dietary and physical activity goals. The intervention will be paired with digital monitoring tools (wireless scale and activity tracker), as well as access to a closed Facebook group to foster peer support. AYA survivors nationwide (N=240, diagnosed between ages 15-39 [current age 18-39], posttreatment, body mass index [BMI] 25-50kg/m2) will be randomized to one of two arms: 1) mHealth intervention as described above, or 2) self-guided (digital tools + health education + Facebook). Randomization will be stratified by BMI, sex, and race/ethnicity. Assessments will occur at 0, 3, 6, and 12 months. Percent weight change at 6 months (primary outcome) will be assessed using a remote collection protocol via video weigh-in and wireless scale to facilitate enhanced reach across the US. Secondary outcomes in the full sample include frailty (frailty index), objectively measured physical activity (ActiGraph GT9X Link), dietary intake (ASA24), and quality of life (SF-36), as well as questionnaires assessing hypothesized psychosocial mediators targeted by the intervention. A subsample of participants (n=80) will complete in-person visits at each clinical site at 0, 6, and 12 months to assess changes in body composition, waist circumference, frailty, and biomarkers of aging and cardiometabolic disease. We hypothesize that compared to the self-guided arm, AYAs in the intervention arm will manifest greater percent weight loss at 6 months and better maintenance of weight loss from 6 to 12 months. We also will examine the psychological and behavioral mechanisms of action to inform future optimization efforts, and explore demographic and clinical-related moderators of intervention response. Our findings will accelerate the development of effective remotely-delivered mHealth weight loss interventions to improve outcomes and reduce the burden of morbidity in AYAs.

Site Principal Investigator: Richard Brown, Ph.D.

Funding Source: UVA/NINR

Project Summary: Many patients with advanced prostate cancer along with their decision partners/proxies (DPP) struggle with complex treatment decisions, such as when to start, change or stop cancer directed treatment. Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers.

The study's primary aim is to test the effects of a theory-based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY) and less regret at the time of making an anti-cancer treatment decision. The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and DPPs' perspective.

Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans vs. others in the primary and secondary aims will also be explored. This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University and Virginia Commonwealth University Massey Cancer Center.

The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment. A qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study. Stratification by race (African American and Caucasian/other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used. There will be two groups: the control (enhanced usual care [EUC]) group and the decision intervention (DI) group. The DI group will receive an interactive seven-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with DI.

The primary outcome measures are:

• Decisional conflict (uncertainty)
• Decisional regret
• HRQL-PSY
• Decision-making participation preference

Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention. This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components. This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.

Principal Investigator: Vanessa Sheppard, Ph.D.

Funding Source: American Cancer Society 133800-RSG-19-182-01-CPPB

Project Summary: Black breast cancer (BC) survivors experience the worst mortality outcomes. Most are recommended effective systemic therapies (chemotherapy or adjuvant hormonal therapy), but adherence is often suboptimal. Patient-centered communication (PCC) is central to high-quality care and to treatment adherence. Unfortunately, Black patients experience lower PCC with providers. Improving communication in black survivors around systemic treatment adherence may reduce disparities. Our preliminary data found that black breast cancer survivors wanted: more involvement in their cancer care, communication support, peer-based strategies, streamlined treatment information, and culturally relevant materials.

This study is responsive to research priorities and national recommendations to empower cancer patients in their medical encounters. Guided by an integrative theoretical framework and our promising preliminary data we will employ a two-arm RCT to test whether SIS (N=230) vs. enhanced usual care (EUC N=230) improves communication with providers and systemic therapy adherence in newly diagnosed black BC patients. The EUC arm consists of a low-literacy treatment recommendation summary form. To our knowledge this will be the first study to rigorously test a multifaceted intervention to address communication disparities and cancer treatment adherence.

If successful, with the help of key stakeholders (e.g. community partners, clinicians), we will disseminate and implement our intervention and materials in various settings including NIH's Research Tested Intervention Programs (RTIPs) and oncology clinics.

Principal Investigator: Maria D. Thomson, Ph.D.

Funding Source: National Cancer Institute R01 #5R01CA196576

Project Summary: As health systems and insurers emphasize increased system efficiencies and reduced hospital stays, the responsibility of care for cancer patients is shifting to informal caregivers (CGs) in the home.

The overall goal of this study is to understand CG objective burden, a key and understudied contributor to overall CG burden and how it affects both health and economic outcomes of CGs and to identify potentially modifiable factors impacting CG overall burden.

This multi-site cohort study employs a prospective, longitudinal design that will follow CGs of patients with life-limiting cancer for up to 6 months or until one month after patient death. Data is collected bi-weekly and in person from CGs in their homes using qualitative interviews, quantitative surveys, CG diaries and structured observation.

Principal Investigator: Vanessa Sheppard, Ph.D.

Funding Source: National Cancer Institute R21CA236496

Project Description: Breast cancer is the most diagnosed cancer for Black women. Black women suffer from more aggressive forms of breast cancer (e.g. triple-negative breast cancer) and higher mortality and recurrence rates than their White counterparts. Additionally, Black women, specifically young Black women, have the highest prevalence of BRCA1 or BRCA2 gene mutations, which significantly increases their lifetime risk of developing hereditary breast and ovarian cancer (HBOC). While genetic cancer risk assessments for women at high risk of carrying a mutation inform treatment for survivors and risk management decisions in unaffected women, Black women underutilize this resource when compared to White women. The reasons for disparities in genetic counseling and testing are multifaceted (e.g. access, lack of knowledge); however, studies indicate that increasing access and awareness alone may be insufficient to address disparities. Addressing cultural and psychosocial factors may enhance uptake of genetic counseling and testing. Culturally appropriate information is needed.  

Our experienced multidisciplinary team will conduct a risk communication intervention designed to target emotions and cultural values. Guided by the two evidenced-based theories (Theory of Planned Behavior, Social Cognitive Theory) and our preliminary data, we will conduct a two-phase mixed methods study. In Phase I we will develop a narrative YouTube video intervention that will target key psychosocial factors. In Phase II we will pilot the intervention in Black women at risk of HBOC. Women will be randomized either the YouTube video arm (n=25) or a Print education arm (n=25); all women will be contacted by a scheduler to make an appointment for genetic counseling. Our primary outcome is genetic counseling at 3-months following the receipt of the intervention or print materials; secondary outcomes include psychosocial factors (e.g. knowledge, self-efficacy).

This study meets the Healthy People 2020 goals to enhance GCT in at-risk populations, and the national priorities to increase diversity in genetics research participation while incorporating emotions into cancer research.  Findings will inform new strategies for behavioral interventions targeting Black women at risk of hereditary breast and ovarian cancer and will inform a future multicenter trial.  

Principal Investigator: Vanessa Sheppard, Ph.D.

Funding Source: National Cancer Institute, Grant No. 1UG1CA189869-01

Project Summary: Massey Cancer Center (MCC) will serve as the primary component site for an NCORP Minority/Underserved Community Site award in partnership with nine collaborating community component sites. The overall objectives of this partnership are to extend novel, innovative and effective minority recruitment approaches to an expanded base of community component sites, increase opportunities for minority and medically underserved individuals to participate in cancer clinical trial research (CCTR) and to integrate cancer care delivery research (CCDR) into the overall MB-NCORP.

Accordingly, the specific aims of this proposal are to:

• Establish a research infrastructure that will further enable community component sites to conduct CCTR with an emphasis on trials relevant to minority and medically underserved populations
• Conduct NCI-approved CCTR at the MCC primary component site and throughout the community component sites
• Integrate CCDR into the overall MB-NCORP.

The research design of the MB-NCORP offers a full menu of cancer studies including those in cancer prevention and control, screening, treatment, imaging and CCDR. The proposed research is relevant to the mission of the NCI as MCC and the community component sites will bring cancer clinical trials and research to low-income, minority, and medically underserved individuals who otherwise would not have access to such studies. These studies will address many diverse factors from patient, provider, organizational, and policy perspectives that contribute to known disparities in cancer detection, treatment, and outcomes. Targeting the minority/underserved populations in their communities is a critical step toward alleviating the cancer care disparities prevalent in these populations.

Principal Investigator: Kathy Tossas, Ph.D.

Funding Source: Pfizer Inc. and American Cancer Society

Project Summary: Project COALESCE will facilitate the development and execution of quality improvement initiatives (QI) that address systemic barriers to colorectal (CRC) and cervical (CCa) cancer screening and diagnostic follow-up, prioritizing those that disproportionately impact Black populations. We propose to do this in the primary care settings of selected Federally Qualified Health Centers (FQHCs) located in some of the most underserved communities in southcentral and eastern Virginia. Uniquely, the QI initiatives will utilize community engagement approaches, executing dyadic partnerships between participating FQHCs and local community organizations identified by the FQHC. The purpose of such partnership is to increase the lay community’s input on the development and implementation of QI initiatives, beyond what is traditionally done through FQHC boards of directors, often inclusive of community members. Such closer involvement from the target community may lead to deeper understanding, higher trust, uptake, innovation, and sustainability of QI initiatives, and ensure that approaches chosen to truly represent what is critically needed.

Learn more about the project from VCU Massey Cancer Center.

Principal Investigator: Vanessa L. Sheppard, Ph.D.

Funding Source: National Cancer Institute, Grant No. 2T32CA093423-11

Project Summary: This application seeks continued support for the Training Program in Behavioral and Health Services Cancer Control Research (application # R25 CA093423-06A1) from the National Cancer Institute T32 mechanism. This training program is located within the Massey Cancer Center (MCC) of Virginia Commonwealth University (VCU) and provides transdisciplinary training for predoctoral and postdoctoral candidates in cancer prevention and control research.

The overall goal of this training program is to provide an environment that encourages the development of cancer prevention and control research at the highest levels. Training is targeted to individuals in the social sciences (psychology, sociology, economics, anthropology), public health, biostatistics and those who have completed their clinical requirements for specialty training in medicine and nursing. To accomplish this goal, a training program has been structured to foster transdisciplinary research, a precondition to conducting research in this field. The predoctoral training component aims to recruit potential future investigators to this research area at the earliest time in their careers. This is important if we are to speed up the development of focused cancer prevention and control research by creating a cadre of students who are focused on this research area at the outset of their research training.

The flexible two-year postdoctoral training component helps guide young investigators to this field of study and provides them with integrated but focused training to conduct fundamental and interventional studies in cancer prevention and control. This program will specifically and especially foster research that contributes to the understanding of the production of health disparities in cancer outcomes. VCU is uniquely positioned to provide this training because of its role as a safety net hospital, the population it serves and its standing as an NCI- designated cancer center. The goal of this program is to train the next generation of cancer prevention and control researchers.

To accomplish this goal we will do the following:

• Offer a multidisciplinary integrated research training program with a broad range of research opportunities
• Meet the needs for training in emerging research areas in cancer prevention and control
• Provide training to researchers from diverse academic and ethnic backgrounds and intensive mentoring
• Provide a specialized curriculum that coalesces cancer control strengths at our institution

Principal Investigator: Maria D. Thomson, Ph.D.

Funding Source: NIH/NCI 1P20CA264067-01 Pilot Project 9050

Project Summary: This project addresses colorectal cancer (CRC) screening among Black men within the Massey Comprehensive Cancer Center catchment area. Black men remain a dramatically underserved group that has not equally benefitted from existing CRC education or screening interventions. The objective of this translational science public health project is to design and pilot a CRC screening intervention that is theoretically and empirically informed by ours and others' NCI S2S implementation results, and by our community and clinic partners. The intervention is designed to increase CRC screening (any test) by Black men at 3 months using a scalable, community implemented and easily sharable mHealth platform.