Distance-Based Exercise to Preserve Function and Prevent Disability

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.

• Exercise intervention (Other): Complete supervised TH aerobic and progressive resistance exercise sessions
• Telemedicine (Other), also known as Telehealth: Complete supervised TH aerobic and progressive resistance exercise sessions
• Aerobic Exercise Intervention (Other): Complete unsupervised aerobic exercise
• Exercise Intervention (Other): Receive stationary bike, workbook, gloves, and resistance bands
• Accelerometry (Procedure): Wear accelerometer
• Questionnaire Administration (Other): Ancillary studies
• Interview (Other): Ancillary studies
• Electronic Health Record Review (Other): Ancillary studies

Primary outcomes

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

Secondary outcomes

• 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]: Feasibility of enrolling a diverse patient population will be defined by: Enrolling 80 patients over a 58-week time period, from the date that the study is activated at all 4 enrolling sites and the first patient is enrolled. Descriptive statistics (mean, standard deviation) will be reported for weekly recruitment, along with graphical representations of recruitment trends over time.
• 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]: Descriptive statistics (percentages) will be summarized for patients who meet at least one of the following criteria: Racial or ethnic minority status (African American, Hispanic, Native American, Pacific Islander), low socioeconomic status (defined as residing in an area in one of the top two quintiles of the Neighborhood Deprivation Index), residing in a rural area (Rural-Urban Continuum Codes or Rural-Urban Commuting Area Code, code 4-10).

Other outcomes

• 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]: Descriptive statistics (mean, standard deviation) will be used to summarize changes in 6MWT distance in the study population between baseline and the post-intervention time point.
• 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]: Descriptive statistics (mean, standard deviation) will be used to summarize changes in grip strength in the study population between baseline and the post-intervention time point
• 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]: Descriptive statistics (mean, standard deviation) will be used to summarize changes in objectively measured physical activity using the accelerometer, including average daily step count, average daily minutes of sedentary time, light activity, and moderate-to-vigorous activity.
• Self-reported 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]: Descriptive statistics (mean, standard deviation) will be used to summarize self-reported changes (7-Day Physical Activity Recall Interview) in physical activity in the study population between baseline and the post-intervention time point.
• Relationship between predicted 6MWT and baseline 6MWT [At baseline]: Person correlation coefficient will be used to summarize the relationship between the predicted 6MWT and the baseline 6MWT.
• Changes in patient reported outcomes [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]: Descriptive statistics (mean, standard deviation) will be used to summarize changes in patient reported outcomes between baseline, end of intervention, and 3-months post intervention in the study population.
• Employment status [Up to 3-months post-intervention]: Descriptive statistics (frequency table) histogram will be used to explore the employment status over time in the study population.

Sex: All, ages: 18 Years to any

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:

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• Jennifer Ligibel, MD, Study chair, Alliance for Clinical Trials in Oncology
• Kathryn Schmitz, MD, Study chair, Alliance for Clinical Trials in Oncology