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.
Eligibility criteria
This trial does not accept healthy volunteers
Qualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Exercise intervention
Other intervention
Complete supervised TH aerobic and progressive resistance exercise sessions
Telemedicine
Other intervention
Complete supervised TH aerobic and progressive resistance exercise sessions
Aerobic Exercise Intervention
Other intervention
Complete unsupervised aerobic exercise
Exercise Intervention
Other intervention
Receive stationary bike, workbook, gloves, and resistance bands
Accelerometry
Procedure/Surgery
Wear accelerometer
Questionnaire Administration
Other intervention
Ancillary studies
Interview
Other intervention
Ancillary studies
Electronic Health Record Review
Other intervention
Ancillary studies
Treatment groups
104 Participants
are divided into 1 treatment group
Group A: Supportive care (DEFEND)Experimental treatment 7 interventions
Trial outcomes
Primary outcomes
1
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
2
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
Secondary outcomes
1
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
2
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
Other outcomes
1
Change in 6 Minute Walk Test (6MWT) distance
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.
Time frame
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
2
Change in grip strength
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
Time frame
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
3
Objective changes in physical activity
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.
Time frame
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
4
Self-reported changes in physical activity
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.
Time frame
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
Sponsors and contacts
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