Breast CancerRESETNCT07101861
Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
A study testing Survivors RESET in people with Breast Cancer and Obesity, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The overall object of this project is to test the feasibility and acceptability of an adapted stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Obesity
- What is being tested?
- Survivors RESET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2024to 1 Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as non-Hispanic Black
- Self-identify as cisgendered female.
- Are ≥ age 18.
- Have a history of stage 0-3 breast cancer diagnosis treated for curative intent.
- Have completed all adjuvant or neoadjuvant chemotherapy, radiation, and surgery at least 21 days prior to study registration but may continue on hormonal therapy and Abemaciclib therapy.
- Have a measured BMI ≥ 30 kg/m2.
- Willing to participate for the entire 4-month duration.
Who cannot join
- Are pregnant or are planning to become pregnant during the study period.
- Have a known major medical or psychological condition known to influence weight loss [e.g., medicated or poorly controlled diabetes (HbA1c > 8%), uncontrolled hypertension (BP>160 mm Hg systolic or BP>100 mm Hg diastolic), cardiovascular event in the past 12 months, history of gastric bypass or bariatric surgery].
- History of psychiatric hospitalization in past 2 years.
- History of substance abuse or eating disorder.
- Any other condition by which a medical professional has suggested diet modification, physical activity, and/or weight loss would be contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
The overall object of this project is to test the feasibility and acceptability of an adapted stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress. We will also conduct pre- and post-intervention assessments of weight, allostatic load, and patient reported outcomes among study participants.
- Conditions
- Breast Cancer, Obesity
- Being tested
- Survivors RESET
- Medical subject headings
- Breast Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivors RESETBehavioural
16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
| Study group | Role | What they receive |
|---|---|---|
| Survivors RESET intervention | Experimental | Not described Receives: Behavioral: Survivors RESET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Percentage of participants who are contacted and enroll in the study.
Measured: Baseline
Retention Rate
Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).
Measured: Baseline to Month 4
Adherence
Adherence will be assessed by the number of treatment sessions attended.
Measured: Baseline to Month 4
Secondary outcomes (2)
4-month mean change in weight
Weight change as measured by a SECA scale in kilograms at baseline and month 4 will be calculated and averaged
Measured: Baseline to Month 4
4-month mean change in allostatic load score
Allostatic load score will be calculated using a validated equation. Change from baseline to month 4 will be calculated and averaged.
Measured: Baseline to Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start20 Jan 2024
- Primary completion7 Jun 2025
- Study completion1 Aug 2025
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 H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Carson, PhD, MPH, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101861
- Sponsor's protocol ID
- MCC-22616
- Acronym
- RESET
- Status last verified
- May 2026
- First submitted
- 28 Jul 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
- ClinicalTrials.gov ID
- NCT07101861
- Acronym / sponsor ID
- RESET / MCC-22616
- Conditions
- Breast Cancer, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 3 Aug 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.
The overall object of this project is to test the feasibility and acceptability of an adapted stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress. We will also conduct pre- and post-intervention assessments of weight, allostatic load, and patient reported outcomes among study participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors RESET intervention | Experimental | Behavioral: Survivors RESET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identify as non-Hispanic Black
- Self-identify as cisgendered female.
- Are ≥ age 18.
- Have a history of stage 0-3 breast cancer diagnosis treated for curative intent.
- Have completed all adjuvant or neoadjuvant chemotherapy, radiation, and surgery at least 21 days prior to study registration but may continue on hormonal therapy and Abemaciclib therapy.
Key exclusion criteria (5 listed)
- Are pregnant or are planning to become pregnant during the study period.
- Have a known major medical or psychological condition known to influence weight loss [e.g., medicated or poorly controlled diabetes (HbA1c > 8%), uncontrolled hypertension (BP>160 mm Hg systolic or BP>100 mm Hg diastolic), cardiovascular event in the past 12 months, history of gastric bypass or bariatric surgery].
- History of psychiatric hospitalization in past 2 years.
- History of substance abuse or eating disorder.
- Any other condition by which a medical professional has suggested diet modification, physical activity, and/or weight loss would be contraindicated.
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 |
|---|---|---|
| Survivors RESET16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training | Behavioural | Survivors RESET intervention |
Primary outcome
Enrollment Rate
Time frame: Baseline
Percentage of participants who are contacted and enroll in the study.
Retention Rate
Time frame: Baseline to Month 4
Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).
Adherence
Time frame: Baseline to Month 4
Adherence will be assessed by the number of treatment sessions attended.
2 secondary outcomes
4-month mean change in weight
Time frame: Baseline to Month 4
4-month mean change in allostatic load score
Time frame: Baseline to Month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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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.
Tiffany Carson, PhD, MPH principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivors RESET in people with Breast Cancer and Obesity, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enrollment Rate (time frame: Baseline). The study lists 3 primary outcomes in all. 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 18 May 2026.