Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07474090
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Breast Carcinoma
  • Breast Inflammatory Carcinoma
  • Locally Recurrent Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise Intervention — OTHER
    Attend virtual personalized exercise sessions
  • Educational Intervention — OTHER
    Attend organized health workshops
  • Supportive Care — OTHER
    Receive Fitbit device, resistance bands, and/or loaner tablet
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo CMR
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo ExeCMR
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Accelerometry — PROCEDURE
    Ancillary Studies
  • Electronic Health Record Review — OTHER
    Ancillary Studies
  • Cardiopulmonary Exercise Testing — OTHER
    Undergo CPET

Study Details

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.

Key Dates

Start date
May 27, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Peak oxygen consumption (VO2) [ Time Frame: At baseline and 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Wake Forest NCORP RBWinston-SalemNorth Carolina27157
Glenn Lesser, MD
[email protected]
336-716-0891
Karen Craver, MHA
[email protected]
336-716-0891
Wake Forest NCORP Research BaseWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Wake Forest NCORP RB· Winston-Salem, NCWake Forest NCORP Research Base· Winston-Salem, NC

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