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BREAST CANCER RESILIENCY THROUGH EXERCISE PROGRAM (B-REP): PILOT STUDY

Primary Investigator
Fong, Angela
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT06100263
UM Number
2023.092
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Breast Oncology
ID (Protocol)
50439
Secondary Protocol No
HUM00244376
Scope
Unspecified
Sponsor Type
National
Disease Site
Breast
Summary
The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and a health education control among 60 Black breast cancer survivors.

Eligibility: Inclusion Criteria
  •   Women will be eligible if they meet the following criteria:
  •   * self-identify as Black or African American or Afro-Latina/e;
  •   * are >=18 years old;
  •   * have a confirmed diagnosis of breast cancer, Stage I to IIIA;
  •   * have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable;
  •   * are not meeting current cancer-specific resistance exercise guidelines of >= 2 times per week; and
  •   * are able to speak and understand English.
Exclusion Criteria
  •   * metastatic disease;
  •   * medical reason that precludes them from increasing current exercise levels;
  •   * planned elective surgery during study period;
  •   * pregnant or plans to become pregnant during the study period;
  •   * plans to move out of United States during the study period; (the rationale for this exclusion is that it will be difficult to conduct the in-person assessments if a participant leaves the United States);
  •   * current enrollment in another exercise trial; and/or
  •   * inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.