TIP66 Feasibility of the THRIVE Wellness Program for Young Breast Cancer Survivors: A Multicenter Pilot Trial

Background

Advances in breast cancer detection and treatment have led to a significant increase in survival. Over 90% of women diagnosed between 2015 and 2021 survive 5 years post diagnosis. Young breast cancer survivors diagnosed younger than or equal to 40 years of age represent a unique and underserved population that faces persistent psychosocial and physical challenges—including disrupted body image, fertility concerns, fatigue, anxiety, and fear of recurrence—that are not fully addressed by standard follow-up care. Existing survivorship guidelines emphasize the need for interventions targeting health behaviors and emotional well-being. However, few studies focus on this young demographic, and no lifestyle medicine interventions have been evaluated exclusively in breast cancer survivors younger than or equal to 40 years of age. Survivorship programs are needed to fill this gap. The THRIVE Wellness Program is a novel 6-week group intervention grounded in lifestyle medicine pillars designed to empower young survivors with strategies in physical activity, nutrition, sleep, and psychosocial well-being. This study aims to assess the feasibility, acceptability, and survivorship impact of THRIVE in a young breast cancer survivor population across multiple treatment centers within the same health system.

Materials and Methods

This randomized, multicenter clinical trial will recruit, screen, and enroll 24 young female breast cancer survivors who meet key inclusion criteria: younger than or equal to 45 years, diagnosed at younger than or equal to 40 years with stage I to III disease within the past 5 years, not on active chemotherapy, ECOG performance status of 0 to 1, and English proficient. Once informed consent is obtained, participants will be randomly assigned to either the intervention or a control group that will receive the program in the future (Figure). The intervention will consist of 6 weekly 90-minute in-person group sessions led by clinicians, focusing on selected lifestyle medicine domains: physical activity, sleep, nutrition, psychosocial coping with a growth mindset, managing late effects, and optimizing long-term survivorship through behavioral changes. Sessions will be facilitated using the shared medical appointment model for insurance coverage and reimbursement. All participants will complete validated, comprehensive surveys at baseline and post intervention to assess lifestyle behaviors, coping abilities, emotional well-being, and quality of life. The intervention arm will additionally provide feedback on program satisfaction. Feasibility outcomes, defined as greater than or equal to 70% enrollment, attendance, and survey completion will be assessed. Data will be analyzed with descriptive and inferential statistics. Within-group pre- and post statistical comparisons in the THRIVE vs control arms will evaluate the intervention’s effects relative to control. The intervention will consist of 6 weekly 90-minute in-person group sessions led by clinicians, focusing on selected lifestyle medicine domains: physical activity, sleep, nutrition, psychosocial coping with a growth mindset, managing late effects, and optimizing long-term survivorship through behavioral changes. Sessions will be facilitated using the shared medical appointment model for insurance coverage and reimbursement. All participants will complete validated, comprehensive surveys at baseline and post intervention to assess lifestyle behaviors, coping abilities, emotional well-being, and quality of life. The intervention arm will additionally provide feedback on program satisfaction. Feasibility outcomes, defined as greater than or equal to 70% enrollment, attendance, and survey completion will be assessed. Data will be analyzed with descriptive and inferential statistics. Within-group pre- and post statistical comparisons in the THRIVE vs control arms will evaluate the intervention’s effects relative to control.

Status

The institutional review board is currently under review. After approval, the investigators will begin to screen and enroll 24 patients to be randomly assigned to either the intervention or control group.