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

June 24, 2025 updated by: University of Florida

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gratitude, exercise and mindfulness program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 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.
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Lakeshia Cousin, PhD, APRN, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF-CCPS-0XX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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