Breast Cancer Resiliency Through Exercise Program (B-REP)

Официальное название

Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study

Обзор

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 waitlist control among 30 Black breast cancer survivors

Подробное описание

14AUG2025- The sample size was updated, and the questionnaire was split into 2 questionnaires, as a planned solution in response to a low accrual

28OCT2025- Amendment was processed to update design and intervention items. The exercise threshold was changed from a 1-repeition maximum (1RM) to a 5-repeptition maximum (5RM). Since the intervention includes functional exercises, so we elected to use a functional strength (5RM) outcome rather than a maximal strength outcome (1RM) to better align with the intervention. The control condition was changed to a waitlist design. A waitlist control is more engaging, and there is a higher likelihood of retaining control participants.

Вмешательства

• Другое Individualized exercise program
  guided exercise program for 12 weeks
• Другое Control Arm
  Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks

Первичные конечные точки

• Feasibility of the exercise program (Retention) [Срок оценки: up to 24 weeks after start of intervention]
• Feasibility of the exercise program (Adherence) [Срок оценки: 12 weeks after start of intervention]
• Feasibility of the exercise program (fidelity) [Срок оценки: 12 weeks after start of intervention]
• Satisfaction of program [Срок оценки: up to 24 weeks after start of intervention]
• Affective attitude [Срок оценки: up to 24 weeks after start of intervention]
• Perceived burden [Срок оценки: up to 24 weeks after start of intervention]
• Outcome expectation [Срок оценки: up to 24 weeks after start of intervention]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06100263 · UMCC 2023.092 · HUM00244376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗