Distance-Based Exercise to Preserve Function and Prevent Disability

This study is looking at whether an exercise program delivered virtually (through video calls) can help cancer patients manage side effects like fatigue and weakness during treatment. Many cancer treatments can cause these side effects, making daily activities difficult. While exercise can help, it's often hard to start during treatment. This study provides supervised aerobic and resistance exercises through telehealth sessions, and also includes unsupervised aerobic exercise. You would receive equipment like a stationary bike and resistance bands. The main goals are to see how many exercise sessions participants complete and how many stay in the program, to understand if this virtual approach is practical for people with cancers such as breast, bladder, and anal cancer. The study aims to enroll 104 participants.

Study design
This is an interventional study with a planned enrollment of 104 participants. It is not specified if it is randomized or blinded.
What's involved
You would complete supervised aerobic and progressive resistance exercise sessions, and unsupervised aerobic exercise. You would also wear an accelerometer and participate for up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up to 3 months post-intervention for patient-reported outcomes.

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NCT07059884

Distance-Based Exercise to Preserve Function and Prevent Disability

Recruiting
NAAges 18+InterventionalSupportive care
Alliance for Clinical Trials in Oncology
~104 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Exercise interventionTelemedicineAerobic Exercise InterventionAccelerometryQuestionnaire AdministrationInterview

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of completed exercise sessions (Feasibility)
Measured over Up to 6 months
+1 more outcome measured
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
18 sites across 4 states
California9
Pennsylvania5
North Carolina3
Massachusetts1
  • Jennifer Ligibel, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology
  • Kathryn Schmitz, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology

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Eligibility criteria

Inclusion

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:
CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English
  • Percentage of completed exercise sessions (Feasibility)Up to 6 months

    Feasibility will be defined through intervention adherence. Will set a priori thresholds for this outcome to define success as detailed. For evaluating the uptake of the intervention, will assess the percentage of enrolled participants who complete at least 70% of prescribed exercise sessions. Will calculate the proportion of participants meeting this threshold and compare it to the predefined success criterion of 80%. Descriptive statistics (percentages) will be reported along with 95% confidence intervals.

  • Intervention attrition rate (Feasibility)Up to 6 months

    Feasibility will be defined through intervention attrition. Will set a priori thresholds for this outcome to define success as detailed. To examine attrition from the trial, will calculate the attrition rate by dividing the number of participants who drop out of the trial by the total number of enrolled participants. The a priori acceptable attrition rate is no greater than 20%. Descriptive statistics (attrition rate) will be presented, and a comparison with the predefined threshold will be made.