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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
104
Complete supervised TH aerobic and progressive resistance exercise sessions
Complete supervised TH aerobic and progressive resistance exercise sessions
Complete unsupervised aerobic exercise
Receive stationary bike, workbook, gloves, and resistance bands
Wear accelerometer
Ancillary studies
Ancillary studies
Ancillary studies
Kaiser Permanente Dublin
Dublin, California, United States
RECRUITINGKaiser Permanente-Fremont
Fremont, California, United States
RECRUITINGKaiser Permanente Fresno Orchard Plaza
Fresno, California, United States
RECRUITINGKaiser Permanente-Modesto
Modesto, California, United States
RECRUITINGKaiser Permanente-Oakland
Oakland, California, United States
RECRUITINGKaiser Permanente-South Sacramento
Sacramento, California, United States
RECRUITINGKaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
RECRUITINGKaiser San Rafael-Gallinas
San Rafael, California, United States
RECRUITINGKaiser Permanente-Vallejo
Vallejo, California, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITING...and 8 more locations
Percentage of completed exercise sessions (Feasibility)
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.
Time frame: Up to 6 months
Intervention attrition rate (Feasibility)
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.
Time frame: Up to 6 months
Weekly recruitment rate
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.
Time frame: 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
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).
Time frame: From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks
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