Breast Cancer Resiliency Through Exercise Program (B-REP)

Breast Cancer Female Clinical Trial

— B-REP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100263
• Other study ID #: UMCC 2023.092
• Secondary ID: HUM00244376
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Cancer AnswerLine
• Phone: 1-800-865-1125
• Email: CancerAnswerLine[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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 0I 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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Individualized exercise program
guided exercise program for 12 weeks
• Control Arm
American Cancer Society Physical Activity and the Person with Cancer summary for patients will be provided

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the exercise program (Retention)	Percent of patients that complete the intervention	up to 24 weeks after start of intervention
Primary	Feasibility of the exercise program (Adherence)	Percent of patients that complete the exercise sessions	12 weeks after start of intervention
Primary	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
Primary	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
Primary	Affective attitude	36-item scale assessing views, attitude, and experiences in exercise87	up to 24 weeks after start of intervention
Primary	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
Primary	Outcome expectation	15-item scale assessing physical, social, and self-evaluative outcomes of exercise	up to 24 weeks after start of intervention