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

NCT06852560 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Lakeshia Cousin, PhD, APRN · University of Florida

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-07-31
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06852560 on ClinicalTrials.gov