Distance-Based Exercise to Preserve Function and Prevent Disability

Last updated: April 6, 2026
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

Electronic Health Record Review

Dumbbell Exercise Intervention

Questionnaire Administration

Clinical Study ID

NCT07059884
A222302
NCI-2025-01495
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologicallyconfirmed cancer

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiatingoutpatient cytotoxic chemotherapy for curative intent (for any malignancy) of atleast 10 weeks duration (with or without concurrent radiation, immunotherapy, orother targeted therapy). Patients must be enrolled and baseline measures collectedon or before administration of their second cycle of cytotoxic therapy. Patientsreceiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvantor adjuvant setting for solid tumors are eligible. Patients receiving outpatientcytotoxic chemotherapy given for curative intent for hematologic malignancies, aswell as patients receiving definitive chemoradiation for solid tumors, are alsoeligible. 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 inthe medical record of severe cardiovascular, respiratory or musculoskeletal diseaseor joint problems that preclude moderate physical activity. Examples would includeunstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease,and osteoarthritis requiring imminent joint replacement. Moderate arthritis thatdoes not preclude physical activity is not a reason for ineligibility

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, becausethis study involves remotely delivered exercise, and cannot be breast-feeding aspatients must be receiving cytotoxic chemotherapy, during which breast-feeding iscontraindicated

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation inthe medical record of current alcohol or substance abuse

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employmentof at least 30 hours per week at the time of cancer diagnosis

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagementin competitive sports (e.g. not training for running races, triathlons, etc) AND noself-report of twice weekly progressive resistance exercise training within the pastyear

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6minutes (use of assistive devices will be allowed)

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weightloss, physical activity, or dietary intervention clinical trial

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 450 meters orless

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment orsupportive care trials (other than those focused on weight loss or exercise) isallowed with the permission of the Alliance Executive Officer and both studies'study chairs

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individualswho can comprehend and read English given that participation in the study willrequire the ability to read intervention materials and work with a coach throughtelehealth sessions

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate theneeds of deaf or blind participants as the study relies on language andvisualization of exercise through telehealth sessions

  • CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff fromenrolling sites who meet following criterion will be deemed eligible to participateas a clinical stakeholder:

  • Providing clinical care for participating patients on this study
  • CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 104
Treatment Group(s): 8
Primary Treatment: Electronic Health Record Review
Phase:
Study Start date:
February 11, 2026
Estimated Completion Date:
February 18, 2027

Study Description

PRIMARY OBJECTIVES:

I. To establish the feasibility of implementing a virtual exercise intervention trial in a diverse cohort of cancer patients undergoing chemotherapy.

SECONDARY OBJECTIVE:

I. To establish feasibility of enrolling and retaining a diverse patient population.

EXPLORATORY OBJECTIVES:

I. Evaluate changes in 6 Minute Walk Test (6MWT) distance in the study population between baseline and the post-chemotherapy time point.

II. Evaluate changes in grip strength in the study population between baseline and the post-intervention time point.

III. Evaluate objective (accelerometer) and self-reported changes (7-Day Physical Activity Recall Interview) in physical activity in the study population between baseline and the post-intervention time point.

IV. Explore the relationship between the predicted 6MWT and the baseline 6MWT. V. Explore changes in patient reported outcomes between baseline, end of intervention, and 3-months post intervention in the study population.

VI. Explore employment status over time in the study population.

OUTLINE:

Patients complete supervised TH exercise sessions consisting of progressive resistance exercise twice a week (BIW) and complete unsupervised aerobic exercise sessions over 30 minutes three times per week (TIW) until the end of standard of care (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.

After completion of study intervention, patients are followed up at 4 weeks and 3 months.

Connect with a study center

  • Kaiser Permanente Dublin

    Dublin, California 94568
    United States

    Active - Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California 94538
    United States

    Active - Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California 93720
    United States

    Active - Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California 95356
    United States

    Active - Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California 94611
    United States

    Active - Recruiting

  • Kaiser Permanente-South Sacramento

    Sacramento, California 95823
    United States

    Active - Recruiting

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California 95119
    United States

    Active - Recruiting

  • Kaiser San Rafael-Gallinas

    San Rafael, California 94903
    United States

    Active - Recruiting

  • Kaiser Permanente-Vallejo

    Vallejo, California 94589
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina 27284
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Mount Airy

    Mount Airy, North Carolina 27030
    United States

    Active - Recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania 16001
    United States

    Active - Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania 15701
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania 16105
    United States

    Active - Recruiting

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania 16346
    United States

    Active - Recruiting

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