Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2026-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Obesity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Survivors RESET intervention

Group Type EXPERIMENTAL

Survivors RESET

Intervention Type BEHAVIORAL

16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Interventions

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Survivors RESET

16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No