Breast CancerGEMNCT06852560
A Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors
A study testing Gratitude, exercise, and mindfulness program in people with Breast Cancer, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gratitude, exercise, and mindfulness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Gratitude, exercise, and mindfulness program
- Keywords
- Black breast cancer survivors, allostatic load, atherosclerotic cardiovascular disease
- Medical subject headings
- Breast Neoplasms, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude, exercise, and mindfulness programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Gratitude, exercise and mindfulness program | Experimental | Not described Receives: Behavioral: Gratitude, exercise, and mindfulness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
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.
Measured: 8 months
Secondary outcomes (16)
Difference in fasting glucose
Determine the difference in blood fasting glucose between baseline and post-intervention.
Measured: 8 weeks
Difference in hemoglobin A1c
Determine the difference in blood hemoglobin A1c between baseline and post-intervention.
Measured: 8 weeks
Difference in total cholesterol
Determine the difference in blood total cholesterol between baseline and post-intervention.
Measured: 8 weeks
Difference in LDL
Determine the difference in blood LDL between baseline and post-intervention.
Measured: 8 weeks
Difference in HDL
Determine the difference in blood HDL between baseline and post-intervention.
Measured: 8 weeks
Difference in C-reactive protein
Determine the difference in blood C-reactive protein between baseline and post-intervention.
Measured: 8 weeks
Difference in cortisol
Determine the difference in saliva cortisol between baseline and post-intervention.
Measured: 8 weeks
Difference in glomerular filtration rate
Determine the difference in blood glomerular filtration rate between baseline and post-intervention.
Measured: 8 weeks
Difference in albumin to creatinine ratio
Determine the difference in urine albumin to creatinine ratio between baseline and post-intervention.
Measured: 8 weeks
Difference in Gratitude Questionnaire-6 score
Determine the difference in Gratitude Questionnaire-6 score between baseline and post-intervention.
Measured: 8 months
Difference in International Physical Activity Questionnaire score
Determine the difference in International Physical Activity Questionnaire score between baseline and post-intervention.
Measured: 8 months
Difference in The Gratitude Questionnaire-Six Item Form score
Determine the difference in The Gratitude Questionnaire-Six Item Form score between baseline and post-intervention.
Measured: 8 months
Difference in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACTIT-Sp) score
Determine the difference in FACTIT-Sp score between baseline and post-intervention.
Measured: 8 months
Difference in General Self-Efficacy Scale score
Determine the difference in General Self-Efficacy Scale score between baseline and post-intervention.
Measured: 8 months
Difference in Superwoman Schema score
Determine the difference in Superwoman Schema score between baseline and post-intervention.
Measured: 8 months
Difference in Perceived Stress Scale score
Determine the difference in Perceived Stress Scale score between baseline and post-intervention.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: PI has left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lakeshia Cousin, PhD, APRN, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852560
- Sponsor's protocol ID
- UF-CCPS-0XX
- Acronym
- GEM
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEM: A Single-Arm Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06852560
- Acronym / sponsor ID
- GEM / UF-CCPS-0XX
- Conditions
- Breast Cancer
- Keywords
- Black breast cancer survivors, allostatic load, atherosclerotic cardiovascular disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gratitude, exercise and mindfulness program | Experimental | Behavioral: Gratitude, exercise, and mindfulness program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gratitude, exercise, and mindfulness programParticipants 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. | Behavioural | Gratitude, exercise and mindfulness program |
Primary outcome
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.
16 secondary outcomes
Difference in fasting glucose
Time frame: 8 weeks
Difference in hemoglobin A1c
Time frame: 8 weeks
Difference in total cholesterol
Time frame: 8 weeks
Difference in LDL
Time frame: 8 weeks
Difference in HDL
Time frame: 8 weeks
Difference in C-reactive protein
Time frame: 8 weeks
Difference in cortisol
Time frame: 8 weeks
Difference in glomerular filtration rate
Time frame: 8 weeks
Difference in albumin to creatinine ratio
Time frame: 8 weeks
Difference in Gratitude Questionnaire-6 score
Time frame: 8 months
Difference in International Physical Activity Questionnaire score
Time frame: 8 months
Difference in The Gratitude Questionnaire-Six Item Form score
Time frame: 8 months
Difference in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACTIT-Sp) score
Time frame: 8 months
Difference in General Self-Efficacy Scale score
Time frame: 8 months
Difference in Superwoman Schema score
Time frame: 8 months
Difference in Perceived Stress Scale score
Time frame: 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lakeshia Cousin, PhD, APRN principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude, exercise, and mindfulness program in people with Breast Cancer, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.