Virtual exercise program to preserve function and prevent disability during chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility trial delivering a telehealth-based exercise program to adults undergoing outpatient cytotoxic chemotherapy with curative intent. Participants receive twice-weekly supervised resistance sessions via video with trained staff, unsupervised 30-minute aerobic sessions three times per week, adjustable dumbbells for home use, and continuous activity monitoring by accelerometer, continuing until chemotherapy completion or up to six months. Primary objectives are to establish implementation feasibility and to enroll and retain a diverse patient population, with exploratory outcomes including 6-minute walk distance, grip strength, accelerometer-measured activity, patient-reported outcomes, and employment status. The intervention is run at Kaiser Permanente sites in California and uses remote supervision to try to make exercise accessible during treatment.

Why it matters

Who can join: the full rules

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:

\-

Where it's running

• Kaiser Permanente Dublin
  Dublin, California, United States Recruiting
• Kaiser Permanente-Fremont
  Fremont, California, United States Recruiting
• Kaiser Permanente Fresno Orchard Plaza
  Fresno, California, United States Recruiting
• Kaiser Permanente- Modesto MOB II
  Modesto, California, United States Recruiting
• Kaiser Permanente-Oakland
  Oakland, California, United States Recruiting
• Kaiser Permanente-South Sacramento
  Sacramento, California, United States Recruiting

Study contacts

• Study coordinator: Lilli Johnson
• Email: cancercontrolprotocols@alliancenctn.org
• Phone: 773-834-4091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A resource for collecting cancer data and biospecimens

  This study is creating a resource to collect health information and samples from cancer patients and healthy individuals to help improve cancer prevention and treatment strategies.

  Recruiting at 42 sites University of Nebraska · Greenwood Village, Colorado and 41 other locations · NCT02012699

• Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors

  This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.

  Recruiting at 18 sites AstraZeneca · Birmingham, Alabama and 17 other locations · NCT07124000

• Testing MDX2001 for advanced solid tumors

  This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.

  Recruiting at 6 sites Phase 1/2 ModeX Therapeutics, An OPKO Health Company · Denver, Colorado and 5 other locations · NCT06239194

• Using brodalumab to treat immune-related side effects from cancer therapy

  This study is testing if brodalumab can help cancer patients who are having immune-related side effects from their immunotherapy treatment feel better.

  Recruiting Phase 1 Columbia University · New York, New York · NCT06673329

• Validation of a blood test for early cancer detection and monitoring

  This study is testing a blood test to see if it can help find different types of cancer early and monitor patients after treatment.

  Recruiting at 3 sites Adela, Inc · Duarte, California and 16 other locations · NCT05366881

• Using Riluzole to Help Breast Cancer Survivors with Cognitive Issues

  This study is testing if the medication riluzole can help breast cancer survivors who are having trouble with thinking and memory feel better.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT06580002

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.