Clinical trial NCT06852560: A Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors
Official title: GEM: A Single-Arm Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Black breast cancer survivors
allostatic load
atherosclerotic cardiovascular disease
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: 8 months
Secondary outcomes:
measure: Difference in fasting glucose
timeFrame: 8 weeks
measure: Difference in hemoglobin A1c
timeFrame: 8 weeks
measure: Difference in total cholesterol
timeFrame: 8 weeks
measure: Difference in LDL
timeFrame: 8 weeks
measure: Difference in HDL
timeFrame: 8 weeks
measure: Difference in C-reactive protein
timeFrame: 8 weeks
measure: Difference in cortisol
timeFrame: 8 weeks
measure: Difference in glomerular filtration rate
timeFrame: 8 weeks
measure: Difference in albumin to creatinine ratio
timeFrame: 8 weeks
measure: Difference in Gratitude Questionnaire-6 score
timeFrame: 8 months
measure: Difference in International Physical Activity Questionnaire score
timeFrame: 8 months
measure: Difference in The Gratitude Questionnaire-Six Item Form score
timeFrame: 8 months
measure: Difference in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACTIT-Sp) score
timeFrame: 8 months
measure: Difference in General Self-Efficacy Scale score
timeFrame: 8 months
measure: Difference in Superwoman Schema score
timeFrame: 8 months
measure: Difference in Perceived Stress Scale score
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Lakeshia Cousin, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References: