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

Alliance for Clinical Trials in Oncology

Status

Not yet enrolling

Conditions

Hematopoietic and Lymphatic System Neoplasm

Localized Malignant Solid Neoplasm

Treatments

Procedure: Accelerometry

Other: Exercise intervention

Other: Telemedicine

Other: Questionnaire Administration

Other: Interview

Other: Dumbbell Exercise Intervention

Other: Aerobic Exercise Intervention

Other: Electronic Health Record Review

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07059884

A222302

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

104 participants in 1 patient group

Supportive care (DEFEND)

Experimental group

Description:

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.

Treatment: