Breast Cancer Female
Conditions
Brief 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 waitlist control among 30 Black breast cancer survivors
Detailed description
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.
Interventions
guided exercise program for 12 weeks
OTHERControl Arm
Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the exercise program (Retention) | up to 24 weeks after start of intervention | Percent of patients that complete the intervention |
| Feasibility of the exercise program (Adherence) | 12 weeks after start of intervention | Percent of patients that complete the exercise sessions |
| Feasibility of the exercise program (fidelity) | 12 weeks after start of intervention | Upon completion of the trial, a random sample of 10 recorded sessions will be analyzed for fidelity. Research staff who did not conduct the intervention will use a "fidelity checklist" of specific exercises and intervention characteristics (e.g., allowing time for questions, cueing for proper posture and form, etc.) required for each exercise session.. |
| Satisfaction of program | up to 24 weeks after start of intervention | 14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention. |
| Affective attitude | up to 24 weeks after start of intervention | 36-item scale assessing views, attitude, and experiences in exercise87 |
| Perceived burden | up to 24 weeks after start of intervention | Single item, "Now that you've completed this part of the study, how burdensome or difficult did you find the experience. Select the response that best represents your experience." (1= Very burdensome to 5= Not too burdensome.) |
| Outcome expectation | up to 24 weeks after start of intervention | 15-item scale assessing physical, social, and self-evaluative outcomes of exercise |
Countries
United States
Contacts
CONTACTCancer AnswerLine
PRINCIPAL_INVESTIGATORAngela Fong, PhD
University of Michigan Rogel Cancer Center
Outcome results
None listed