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RECRUITING Not applicable ClinicalTrials.gov

Distance-Based Exercise to Preserve Function and Prevent Disability

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT07059884

Registry updated: 2026-10-02
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Description

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

Interventions

  • Exercise intervention (Other)
    Complete supervised TH aerobic and progressive resistance exercise sessions
  • Telemedicine (Other)
    Complete supervised TH aerobic and progressive resistance exercise sessions
  • Aerobic Exercise Intervention (Other)
    Complete unsupervised aerobic exercise
  • Exercise Intervention (Other)
    Receive stationary bike, workbook, gloves, and resistance bands
  • Accelerometry (Procedure)
    Wear accelerometer
  • Questionnaire Administration (Other)
    Ancillary studies
  • Interview (Other)
    Ancillary studies
  • Electronic Health Record Review (Other)
    Ancillary studies

Eligibility criteria

Inclusion Criteria: * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon/rectum, endometrium, esophagus, gallbladder, head/neck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed) * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions * CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder: \* Providing clinical care for participating patients on this study * CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English Exclusion Criteria: \-

Conditions

Localized Malignant Solid Neoplasm Anal Cancer Bladder (Urothelial, Transitional Cell) Cancer Breast Cancer Cervical Cancer Colon Cancer Endometrial Cancer Esophageal Cancer Gall Bladder Cancer Gastric Cancer Kidney Cancer Liver Cancer Lung Cancer Head and Neck Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Rectal Cancer Sarcoma

Locations

  • Kaiser Permanente Dublin — Dublin, California, United States
  • Kaiser Permanente-Fremont — Fremont, California, United States
  • Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States
  • Kaiser Permanente- Modesto MOB II — Modesto, California, United States
  • Kaiser Permanente-Modesto — Modesto, California, United States
  • Kaiser Permanente-Oakland — Oakland, California, United States
  • Kaiser Permanente-South Sacramento — Sacramento, California, United States
  • Kaiser Permanente-San Francisco — San Francisco, California, United States
  • Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
  • Kaiser San Rafael-Gallinas — San Rafael, California, United States
  • Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
  • Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States
  • Kaiser Permanente-Vallejo — Vallejo, California, United States
  • Kaiser Permanente-Walnut Creek — Walnut Creek, California, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Novant Health Cancer Institute - Kernersville — Kernersville, North Carolina, United States
  • Novant Health Cancer Institute - Mount Airy — Mount Airy, North Carolina, United States
  • Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
  • UPMC Hillman Cancer Center at Butler Health System — Butler, Pennsylvania, United States
  • IRMC Cancer Center — Indiana, Pennsylvania, United States
  • UPMC Hillman Cancer Center - New Castle — New Castle, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Northwest — Seneca, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record