Distance-Based Exercise to Preserve Function and Prevent Disability

Обзор

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.

Подробное описание

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.

VII. Explore differences intervention adherence and attrition by:

1. Duration of chemotherapy regimen (12 weeks or less vs more than 12 weeks) 2. Administration of chemotherapy in adjuvant vs neoadjuvant setting 3. Administration of cytotoxic chemotherapy alone vs in combination with radiation 4. Administration of cytotoxic chemotherapy alone vs in combination with immunotherapy or other targeted agent (monoclonal antibody, small molecule inhibitor, etc)

OUTLINE:

Patients complete supervised TH exercise sessions consisting of aerobic exercise over 20 minutes and progressive resistance exercise twice a week (BIW) and complete unsupervised aerobic exercise for a total of 50 minutes per week 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 a stationary bike, workbook, gloves, and resistance bands on study and wear an accelerometer throughout the study.

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

Вмешательства

• Другое Exercise intervention
  Complete supervised TH aerobic and progressive resistance exercise sessions
• Другое Telemedicine
  Complete supervised TH aerobic and progressive resistance exercise sessions
• Другое Aerobic Exercise Intervention
  Complete unsupervised aerobic exercise
• Другое Exercise Intervention
  Receive stationary bike, workbook, gloves, and resistance bands
• Процедура Accelerometry
  Wear accelerometer
• Другое Questionnaire Administration
  Ancillary studies
• Другое Interview
  Ancillary studies
• Другое Electronic Health Record Review
  Ancillary studies

Первичные конечные точки

• Percentage of completed exercise sessions (Feasibility) [Срок оценки: Up to 6 months]
• Intervention attrition rate (Feasibility) [Срок оценки: Up to 6 months]

Вторичные конечные точки (2)

• Weekly recruitment rate [Срок оценки: 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 [Срок оценки: From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 18 центров

• Kaiser Permanente Dublin — Dublin
• Kaiser Permanente-Fremont — Fremont
• Kaiser Permanente Fresno Orchard Plaza — Fresno
• Kaiser Permanente-Modesto — Modesto
• Kaiser Permanente-Oakland — Oakland
• Kaiser Permanente-South Sacramento — Sacramento
• Kaiser Permanente-Santa Teresa-San Jose — San Jose
• Kaiser San Rafael-Gallinas — San Rafael
• … и ещё 10 центров

Идентификаторы

NCT: NCT07059884 · A222302 · NCI-2025-01495

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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