Distance-Based Exercise to Preserve Function and Prevent Disability

Summary

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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:

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Sites (18)

• Kaiser Permanente Dublin, Dublin, California · Recruiting
• Kaiser Permanente-Fremont, Fremont, California · Recruiting
• Kaiser Permanente Fresno Orchard Plaza, Fresno, California · Recruiting
• Kaiser Permanente-Modesto, Modesto, California · Recruiting
• Kaiser Permanente-Oakland, Oakland, California · Recruiting
• Kaiser Permanente-South Sacramento, Sacramento, California · Recruiting
• Kaiser Permanente-Santa Teresa-San Jose, San Jose, California · Recruiting
• Kaiser San Rafael-Gallinas, San Rafael, California · Recruiting
• Kaiser Permanente-Vallejo, Vallejo, California · Recruiting
• Dana-Farber Cancer Institute, Boston, Massachusetts · Recruiting
• Novant Health Cancer Institute - Kernersville, Kernersville, North Carolina · Recruiting
• Novant Health Cancer Institute - Mount Airy, Mount Airy, North Carolina · Recruiting
• Novant Health Forsyth Medical Center, Winston-Salem, North Carolina · Recruiting
• UPMC Hillman Cancer Center at Butler Health System, Butler, Pennsylvania · Recruiting
• IRMC Cancer Center, Indiana, Pennsylvania · Recruiting
• UPMC Hillman Cancer Center - New Castle, New Castle, Pennsylvania · Recruiting
• UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania · Recruiting
• UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania · Recruiting