Distance-Based Exercise to Preserve Function and Prevent Disability (DEFEND)

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 * Note: We are using the 6MWT to identify a group of individuals who are at risk of experiencing a decline in functional status that would result in the patient being unable to participate in gainful employment. Although the threshold of disability differs across individuals, physical functional ability consistent with the ability to perform activities of daily living (such as doing laundry, playing with children, cleaning, sweeping, walking 2.5 miles per hour, carrying or putting groceries away) is demonstrated by the ability to walk 396 meters in a 6MWT. Although not well-defined for individuals with cancer, a threshold of 370 meters identifies patients with the capacity for disability-free survival after major noncardiac surgery. We will thus enroll patients to this study who achieve < 450 m at baseline on the 6MWT, given that they will be at elevated risk for loss of independent function with the typical decrement of walking distance experienced during chemotherapy (at least 54 meters). We have thus set an upper bound of 450 meters on the 6MWT as patients with an estimated 6MWT distance greater than 450 m would not be expected to experience a decline in function sufficient to interfere with their ability to work
• 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