Clinical Trial 22616

• Overview

  Study Title:

  Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels using Educational and Behavioral Tools): A pilot, feasibility study

  Summary:

  The purpose of the study is to assess the feasibility of a culturally-relevant, stress-management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress.

  Objective:

  The overall object of this project is to adapt and test the feasibility and acceptability of a 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

• Inclusion Criteria

  > Inclusion Criteria:
  • Participant self-identifies as non-Hispanic Black
  • Participant self-identifies as cisgendered female
  • Age 18 or older
  • Participant must have a history of Stage 0-3 Breast Cancer Diagnosis treated for curative intent
  • Participant must 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
  • Participant must have a measured Body Mass Index (BMI) of 30 kg/m2 or greater
  • Participant must be willing to participate for the entire 4-month duration.
  • Other criteria may apply

• Exclusion Criteria

  > Exclusion Criteria:
  • Participants will be ineligible if they: (a) are pregnant or are planning to become pregnant during the study period, (b) have a known major medical or psychological condition known to influence weight loss such as 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, (c) history of psychiatric hospitalization in past 2 years, (d) history of substance abuse or eating disorder, or (e) any other condition by which a medical professional has suggested diet modification, physical activity, and/or weight loss would be contraindicated.

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