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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00244376 | Other Identifier | University of Michigan |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Supervised exercise) | Experimental | The individualized program is based on participants' baseline 5-repetition maximum muscular strength assessment and is aligned with current cancer-specific exercise recommendations. The resistance program will follow the FITT principle (frequency, intensity, time, and type): Frequency. Participants will aim for 3 resistance exercise sessions per week. Intensity. Resistance exercise intensity will have a schedule for increased progression by both load via increased weight and volume via increased repetitions and sets. If participants are not able to increase resistance loads as scheduled, they will remain at their current load and volume until the next scheduled increase. 50% of 5-repetition maximum for upper and lower body. 3 sets of 8 to 12 repetitions. 60% of 5-repetition maximum for upper and lower body. 3 sets of 8 to 12 repetitions. 70% of 5-repetition maximum for upper and lower body. 4 sets of 8 to 12 repetitions. |
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| Control (waitlist) | Active Comparator | Participants randomized to the waitlist control condition will be on a waiting list for 24 weeks. Participants in waitlist control condition will complete measures on the same schedule as intervention participants. After 24 weeks, participants will be offered to participate in the online sessions with an exercise trainer using Zoom twice per week for 12- weeks. The sessions will be 30 to 45minutes in length. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized exercise program | Other | guided exercise program for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the exercise program (Retention) | Percent of patients that complete the intervention | up to 24 weeks after start of intervention |
| Feasibility of the exercise program (Adherence) | Percent of patients that complete the exercise sessions | 12 weeks after start of intervention |
| Feasibility of the exercise program (fidelity) | 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.. | 12 weeks after start of intervention |
| Satisfaction of program | 14-item scale measuring ease of use, convenience, engagement, enjoyment, and privacy elements of the intervention. | up to 24 weeks after start of intervention |
| Affective attitude | 36-item scale assessing views, attitude, and experiences in exercise87 | up to 24 weeks after start of intervention |
| Perceived burden | 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.) | up to 24 weeks after start of intervention |
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Inclusion Criteria:
Women will be eligible if they meet the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer AnswerLine | Contact | 1-800-865-1125 | CancerAnswerLine@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Fong, PhD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Control Arm | Other | Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks |
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| Outcome expectation |
15-item scale assessing physical, social, and self-evaluative outcomes of exercise |
| up to 24 weeks after start of intervention |