NCT06852560

A Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors

GEM: A Single-Arm Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study's overall objective is to test the effects of a culturally tailored gratitude, exercise, and mindfulness/emotional freedom techniques (GEM) psychosocial intervention on allostatic load and atherosclerotic cardiovascular disease risk in black women breast Cancer survivors. Allostatic load refers to the cumulative physiological burden of chronic stress, which is a major contributor to CVD risk, impaired immune function, and worse cancer outcomes. Atherosclerotic cardiovascular disease risk encompasses factors such as blood pressure, cholesterol, and glucose control that predict long-term cardiovascular health. Among survivors of breast cancer in the U.S., black women have the highest rates of mortality from breast cancer, cardiometabolic disease, and all causes. These disparities are likely due to complex interactions between socioeconomic, psychosocial, and biological risk factors. A higher prevalence of cardiometabolic risk factors among black women breast cancer survivors is one critical disparity associated with poorer breast cancer outcomes and increased cardiometabolic risk, including that driven by cardiotoxicity from breast cancer treatment. Engagement in physical activity, which reduces cardiometabolic risk, is associated with significant reductions in all-cause and cancer mortality in breast cancer survivors. However, black breast cancer survivors report lower levels of physical activity compared to their white counterparts, and most interventions targeting this behavior have not effectively engaged black women. Interventions that effectively increase physical activity in black women breast cancer survivors hold promise as a means for reducing these persistent disparities in survival outcomes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Gratitude, exercise, and mindfulness program	Participants will be enrolled in an 8-week GEM (Gratitude, Exercise, and Mindfulness) program conducted entirely in person at Blossoming Butterfly in Gainesville, Florida. Participants will attend weekly group sessions combining gratitude journaling, mindfulness-based stress reduction/emotional freedom technique, and physical activity goal-setting. Participants will also be provided with a toolkit to support at-home practices, including gratitude journaling, physical activity tracking, and mindfulness meditation. Blood, saliva and urine will be collected from each participant at baseline and post-intervention to measure the following allostatic load biomarkers: fasting glucose or hemoglobin A1c; lipid panel (total cholesterol, LDL, HDL); C-reactive protein; dehydroepiandrosterone sulfate; cortisol; glomerular filtration rate; and albumin-to-creatinine ratio.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2025-02-28
• Last updated: 2025-06-26