Alisa Boyd

DEPARTMENT –

Epidemiology and Biostatistics

STUDY NAME –

Heart ACT

RESEARCH QUESTION -

In the pilot study phase, we aim to test a multi-disciplinary health behavior intervention in breast cancer survivors. We will recruit 50 people from Zuckerberg San Francisco General (ZSFG) who have been treated for breast cancer to participate in a pilot study of the program. We will measure the acceptability of the language-concordant program and health outcomes in participants, including change in exercise capacity, change in quality of life, change in risk factors, and adverse events.

SPECIFIC AIMS (1/2 page)

In previous work, we developed a multi-disciplinary health behavior intervention in people with a history of breast cancer to reduce heart disease risk after cancer treatment. We developed the intervention using patient- and community-engaged approaches to human-centered design. The primary aim of this research is to determine feasibility of delivering the intervention in a pilot study. Since this is a pilot study, the primary hypotheses are related to feasibility. We hypothesize that we will be able to calculate change in six-minute walk distance (6MWD) and change in quality of life (PROMIS Global Health Mental and Physical Scales) at 12 months in at least 75% of participants. We hypothesize that at least 60% of participants will complete the 12-week program. Rationale: Approximately 60% completion has been achieved in other randomized trials of cardiac rehabilitation. Secondary aims include establishing preliminary data on changes in objective and patient-reported measures including 6MWD, quality of life, health behaviors (medication adherence, physical activity, healthy eating), cognitive function, and potential mechanisms of action of the intervention including self-efficacy, social isolation, and optimism.

STUDY PROCEDURES AND TIMEPOINTS (1/2 page)

Enrollment: Month 1 to Month 12. Baseline study visit (Program Intake visit) will include a medical record review and chart abstraction for the following data: Breast cancer history, Total cholesterol, LDL, HDL, Triglycerides and date of test, Hemoglobin A1c and date of test, Echocardiogram results in the past 5 years.  At this baseline visit, participants will meet be asked to complete the following self-reported questionnaires: Demographics, Medical conditions, Tobacco/Cannabis/Alcohol use, PROMIS-Global Health, Chronic Disease Self-Efficacy, Medication adherence, PROMIS-Cognitive Function, Health literacy, Digital literacy, Hunger vital signs, International Physical Activity Questionnaire, REAP-S dietary questionnaire, PROMIS-Social Isolation, and Life Orientation Test (Optimism). At this baseline visit, participants will be asked to complete the following measurements: Blood pressure, Weight, Height, Six Minute Walk Test (6MWT). Participants will be given a Participant Results Report with these measurements. Intervention will be a 12-week multi-disciplinary health behavior program which will alternate between group and individual sessions each week.

Follow-up: Month 4 to Month 24. Patients will repeat the same questionnaires and measurements at the end of the 12-week program, at the 6-month, and 12-month follow-up visits. Patients will have a celebratory ceremony to graduate from the program in-person. For those who graduate, an exit interview will be conducted for feedback on the intervention and used to improve the following sessions.

FEASIBILITY (1 paragraph) – Please comment on the feasibility of using Eureka for this study and feasibility of executing the study once built.

This study will include the collection of survey data and device data (FitBit), which can be accomplished through Eureka. The Eureka platform will serve as the study data collection platform for a study that is anticipated to start Fall 2024 (initial IRB review has occurred; we are answering final stipulations prior to approval).

FUNDABILITY (1 paragraph) – What is your current funding for this project, or if currently unfunded, how will this support funding applications?

This project is fully funded by a gift to the University. After completing the pilot study, the data will be used as preliminary data to apply for grants to support a multi-center randomized trial of the intervention.

PROFESSIONAL DEVELOPMENT (1 paragraph) – How will this project support the professional development of the team leader and/or team members?

This project will contribute to the professional development of a multi-disciplinary team, including two nurse clinicians and a clinical research coordinator, who collectively identify as BIPOC women driven by a shared passion for advancing their research careers. Through active engagement in the project's multidisciplinary research initiatives, they'll gain exposure to new methodologies, collaborate with experienced researchers, and contribute to generating insights in the field. This immersive experience will not only amplify their technical adeptness but also foster a network of peers and mentors. By harmonizing efforts with diverse experts and making meaningful contributions to innovative research outcomes, both team leader and members will authentically broaden their connections, grow their technological skills, access invaluable mentorship, and fortify their journey towards impactful research careers.

IMPACT (1 paragraph) – What improvements will result if your research succeeds (e.g., what are the public health implications or community benefits)?

If this research succeeds, it will bring about improvements with far-reaching public health implications for breast cancer survivors. Firstly, the successful implementation of the multi-disciplinary health behavior intervention among breast cancer survivors will pave the way for enhanced offering of tailored, patient-centered cardiac rehabilitation programs. These programs will be more accessible, catering to a diverse range of individuals, including women, individuals from racial/ethnic minority backgrounds, and those with lower socioeconomic status. By integrating telehealth technology, fitness wearables like FitBit, and personalized exercise equipment, the intervention will empower healthcare organizations to address barriers to cost, attendance and participation. As a result, individuals who might have previously faced challenges accessing cardiac rehabilitation due to factors like program design, health literacy, and accessibility will now have a more tailored and engaging pathway to improving their heart health. This research success will not only contribute to individual well-being but also generate ripple effects in communities, leading to reduced cardiovascular disease risk and improved overall health outcomes.