Distance-Based Exercise to Preserve Function and Prevent Disability

NCT07059884 | Recruiting DMC

• 2 other identifiers: A222302NCI-2025-01495
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Localized Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Percentage of completed exercise sessions (Feasibility)

  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.

  Up to 6 months

• Intervention attrition rate (Feasibility)

  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.

  Up to 6 months

Secondary Outcomes (2)

• Weekly recruitment rate

  From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks

• Retaining a diverse patient population

  From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks

Other Outcomes (7)

• Change in 6 Minute Walk Test (6MWT) distance

  From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first

• Change in grip strength

  From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first

• Objective changes in physical activity

  From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first

Study Arms (1)

Supportive care (DEFEND)

EXPERIMENTAL

Patients complete supervised TH exercise sessions consisting of progressive resistance exercise BIW and complete unsupervised aerobic exercise sessions over 30 minutes TIW until the end of SOC chemotherapy or up to a total of 6 months, whichever comes first, in the absence of disease progression or unacceptable toxicity. Patients also receive adjustable-weight dumbbells on study and wear an accelerometer throughout the study.

Other: Exercise intervention; Other: Telemedicine; Other: Aerobic Exercise Intervention; Other: Dumbbell Exercise Intervention; Procedure: Accelerometry; Other: Questionnaire Administration; Other: Interview; Other: Electronic Health Record Review

Interventions

Exercise intervention OTHER

Complete supervised TH progressive resistance exercise sessions

Supportive care (DEFEND)

Telemedicine OTHER

Complete supervised TH progressive resistance exercise sessions

Also known as: Telehealth

Supportive care (DEFEND)

Accelerometry PROCEDURE

Wear accelerometer

Supportive care (DEFEND)

Aerobic Exercise Intervention OTHER

Complete unsupervised aerobic exercise sessions

Supportive care (DEFEND)

Dumbbell Exercise Intervention OTHER

Receive adjustable-weight dumbbells

Supportive care (DEFEND)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (DEFEND)

Interview OTHER

Ancillary studies

Supportive care (DEFEND)

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (DEFEND)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed cancer
• REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent (for any malignancy) 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 for solid tumors are eligible. Patients receiving outpatient cytotoxic chemotherapy given for curative intent for hematologic malignancies, as well as patients receiving definitive chemoradiation for solid tumors, 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 or substance abuse
• 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 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 450 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Alliance for Clinical Trials in Oncology: lead

Study Sites (14)

Kaiser Permanente Dublin

Dublin, California, 94568, United States

RECRUITING

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

RECRUITING

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, 93720, United States

RECRUITING

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, 16001, United States

RECRUITING

IRMC Cancer Center

Indiana, Pennsylvania, 15701, United States

RECRUITING

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, 16105, United States

RECRUITING

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346, United States

RECRUITING

MeSH Terms

Interventions

Telemedicine; Accelerometry; Interviews as Topic

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennifer Ligibel, MD

  Alliance for Clinical Trials in Oncology

  STUDY CHAIR

• Kathryn Schmitz, MD

  Alliance for Clinical Trials in Oncology

  STUDY CHAIR

Central Study Contacts

Lilli Johnson

CONTACT

773-834-4091; cancercontrolprotocols@alliancenctn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 18, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (14)