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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06852560
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-05
• Primary Completion: 2026-07
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Participants must identify as Black women who have survived breast cancer
• Participants must have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) at least 6 months prior to enrollment
• Adults ≥ 18 years old
• Capable of completing study requirements
• Informed consent obtained from the participant and documentation of participant agreement to comply with all study-related processes

Exclusion Criteria

• Females who are pregnant or breastfeeding
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• Impaired cognition (i.e., inability to follow and respond appropriately during screening).
• Participants currently enrolled in other lifestyle, exercise, or psychosocial interventions will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility	8 months	Determine the feasibility of collecting a comprehensive panel of allostatic load biomarkers and atherosclerotic cardiovascular disease risk components. This will be measured by the number of subjects who successfully complete the baseline assessments, which include self-reported questionnaires and biomarker collection, participate in a minimum number of 6 of 8 intervention sessions, and complete the post-intervention assessments, including follow-up questionnaires and biomarker collection.

Secondary Outcome Measures

Name	Time	Method
Difference in fasting glucose	8 weeks	Determine the difference in blood fasting glucose between baseline and post-intervention.
Difference in hemoglobin A1c	8 weeks	Determine the difference in blood hemoglobin A1c between baseline and post-intervention.
Difference in total cholesterol	8 weeks	Determine the difference in blood total cholesterol between baseline and post-intervention.
Difference in LDL	8 weeks	Determine the difference in blood LDL between baseline and post-intervention.
Difference in HDL	8 weeks	Determine the difference in blood HDL between baseline and post-intervention.
Difference in C-reactive protein	8 weeks	Determine the difference in blood C-reactive protein between baseline and post-intervention.
Difference in cortisol	8 weeks	Determine the difference in saliva cortisol between baseline and post-intervention.
Difference in glomerular filtration rate	8 weeks	Determine the difference in blood glomerular filtration rate between baseline and post-intervention.
Difference in albumin to creatinine ratio	8 weeks	Determine the difference in urine albumin to creatinine ratio between baseline and post-intervention.
Difference in Gratitude Questionnaire-6 score	8 months	Determine the difference in Gratitude Questionnaire-6 score between baseline and post-intervention.
Difference in International Physical Activity Questionnaire score	8 months	Determine the difference in International Physical Activity Questionnaire score between baseline and post-intervention.
Difference in The Gratitude Questionnaire-Six Item Form score	8 months	Determine the difference in The Gratitude Questionnaire-Six Item Form score between baseline and post-intervention.
Difference in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACTIT-Sp) score	8 months	Determine the difference in FACTIT-Sp score between baseline and post-intervention.
Difference in General Self-Efficacy Scale score	8 months	Determine the difference in General Self-Efficacy Scale score between baseline and post-intervention.
Difference in Superwoman Schema score	8 months	Determine the difference in Superwoman Schema score between baseline and post-intervention.
Difference in Perceived Stress Scale score	8 months	Determine the difference in Perceived Stress Scale score between baseline and post-intervention.