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

NCT07101861 | Completed

• 1 other identifier: MCC-22616
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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. We will also conduct pre- and post-intervention assessments of weight, allostatic load, and patient reported outcomes among study participants.

Conditions

Breast Cancer; Obesity

Outcome Measures

Primary Outcomes (3)

• Enrollment Rate

  Percentage of participants who are contacted and enroll in the study.

  Baseline

• Retention Rate

  Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).

  Baseline to Month 4

• Adherence

  Adherence will be assessed by the number of treatment sessions attended.

  Baseline to Month 4

Secondary Outcomes (2)

• 4-month mean change in weight

  Baseline to Month 4

• 4-month mean change in allostatic load score

  Baseline to Month 4

Study Arms (1)

Survivors RESET intervention

EXPERIMENTAL

Behavioral: Survivors RESET

Interventions

Survivors RESET BEHAVIORAL

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

Survivors RESET intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiffany Carson, PhD, MPH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: January 20, 2024
• Primary Completion: June 7, 2025
• Study Completion: August 1, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)