Recruiting

Exercise ProgramDistance-Based Exercise to Preserve Function and Prevent Disability

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT07059884

Conditions

Localized Malignant Solid Neoplasm

Anal Cancer

Bladder (Urothelial, Transitional Cell) Cancer

Breast Cancer

Cervical Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise intervention

Telemedicine

Aerobic Exercise Intervention

Exercise Intervention

Accelerometry

Study Details

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

Localized Malignant Solid Neoplasm

Anal Cancer

Bladder (Urothelial, Transitional Cell) Cancer

Breast Cancer

Cervical Cancer

Study ID

NCT07059884

Start date

Feb 11, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

\-

Study Design

Enrollment

104 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (DEFEND)

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.

Interventions

Exercise intervention

Complete supervised TH aerobic and progressive resistance exercise sessions

Telemedicine

Complete supervised TH aerobic and progressive resistance exercise sessions

Aerobic Exercise Intervention

Complete unsupervised aerobic exercise

Exercise Intervention

Receive stationary bike, workbook, gloves, and resistance bands

Accelerometry

Wear accelerometer

Questionnaire Administration

Ancillary studies

Interview

Ancillary studies

Electronic Health Record Review

Ancillary studies

Primary outcome measure

Percentage of completed exercise sessions (Feasibility) [ Time Frame: Up to 6 months ]
Intervention attrition rate (Feasibility) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Lilli Johnson

773-834-4091 cancercontrolprotocols@alliancenctn.org

Locations

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Modesto

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Jennifer M. Suga

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Jennifer A. Ligibel

Novant Health Cancer Institute - Kernersville

Recruiting

Kernersville, North Carolina, United States, 27284

Contacts

Site Public Contact

336-718-8335 asmarrs@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Cancer Institute - Mount Airy

Recruiting

Mount Airy, North Carolina, United States, 27030

Contacts

Site Public Contact

336-718-8335 asmarrs@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Site Public Contact

336-718-8335 pjordan@novanthealth.org

Principal Investigator:

Judith O. Hopkins

UPMC Hillman Cancer Center at Butler Health System

Recruiting

Butler, Pennsylvania, United States, 16001

Contacts

Site Public Contact

412-389-5208 haneydl@upmc.edu

Principal Investigator:

Kathryn Schmitz

IRMC Cancer Center

Recruiting

Indiana, Pennsylvania, United States, 15701

Contacts

Site Public Contact

412-389-5208 haneydl@upmc.edu

Principal Investigator:

Kathryn Schmitz

UPMC Hillman Cancer Center - New Castle

Recruiting

New Castle, Pennsylvania, United States, 16105

Contacts

Site Public Contact

412-389-5208 haneydl@upmc.edu

Principal Investigator:

Kathryn Schmitz

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Kathryn Schmitz

UPMC Cancer Center at UPMC Northwest

Recruiting

Seneca, Pennsylvania, United States, 16346

Contacts

Site Public Contact

814-676-7900

Principal Investigator:

Kathryn Schmitz

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-08-05.