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Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a healthy lifestyle during chemotherapy. The PAI in this study consists of virtual exercise sessions personalized to the needs of the patient, which may make it easier for patients to stay active during chemotherapy. HLI with PAI may be a more effective way to help maintain ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \[if prior treatment received ≥ 2 years prior\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \[ER\], progesterone receptor \[PR\], human epidermal growth factor receptor 2 \[HER2\], etc.) are acceptable

• Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy

• Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group

• Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report

• Able to hold breath for 8 seconds

• Must be able to read and understand English language

• Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program

• Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program

• Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed

Locations
United States
North Carolina
Wake Forest NCORP RB
RECRUITING
Winston-salem
Wake Forest NCORP Research Base
ACTIVE_NOT_RECRUITING
Winston-salem
Contact Information
Primary
Karen Craver, MT, MHA
NCORP@wfusm.edu
336-716-0891
Time Frame
Start Date: 2026-05-27
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 120
Treatments
Experimental: Arm 1 (PAI+HLI)
Within three weeks or less of chemotherapy start date, patients access the Trainerize app and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24 in the absence of unacceptable toxicity. Patients also receive a Fitbit device, resistance bands, and a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.
Active_comparator: Arm 2 (HLI)
Within three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov