Actively Recruiting
Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation
Led by University of Colorado, Denver · Updated on 2026-02-05
134
Participants Needed
2
Research Sites
121 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a telehealth exercise program designed for rural cancer survivors experiencing cancer-related fatigue (CRF). This study aims to determine if the program improves CRF and how fatigue, metabolism, and physical function change during the intervention. The study is a randomized controlled trial comparing the exercise program with a wait-list control group, which will receive the program after a 12-week waiting period. The program focuses on breast and prostate cancer survivors who have completed treatment with curative intent within the last five years. The 12-week intervention is delivered entirely remotely through videoconference sessions with cancer exercise specialists and a personal training smartphone or internet application. Participants complete regular symptom monitoring via emailed surveys every two weeks. If fatigue symptoms do not improve as expected, additional telehealth sessions are provided to adjust exercise plans. The wait-list control group maintains their usual physical activity during the initial 12 weeks before receiving the full exercise program. Optional laboratory assessments including treadmill exercise tests and body composition analysis are available at specific study sites before and after the program. Participants will complete virtual physical assessments and provide dried blood samples at home every two weeks throughout the study. These assessments include measures of physical function and fatty acid oxidation. Those able and willing may attend laboratory visits for more detailed exercise and body composition testing. The primary outcome is the change in cancer-related fatigue measured at 12 weeks. Secondary outcomes include quality of life, anxiety and depression, physical function, daily activity, sleep time, and metabolic profiles. The total study duration includes the 12-week intervention or wait period with ongoing monitoring and assessments.
CONDITIONS
Brief Title
Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 90 years
- Diagnosis of breast or prostate cancer
- Completed cancer treatment with curative intent more than 3 months and less than 5 years before starting the study
- Cancer treatment included hormonal, radiation, chemotherapy, and/or immunotherapy (surgery only not eligible)
- For breast cancer, currently receiving maintenance hormonal therapy with no planned changes in next 6 months
- Home zip code classified as rural by HRSA
- Moderate or greater fatigue (greater than 3 out of 10)
- Access to high-speed home internet
- Own a smartphone or laptop with a front-facing camera
- Able and willing to provide informed consent
- Willing to participate in a 12-week telehealth exercise program or 12-week wait period with remote assessments every 2 weeks
- Able and willing to provide contact info for a local support person
- Able and willing to provide contact info for a local primary care provider
- Able to provide signed physician clearance for exercise if indicated by screening questionnaires
You will not qualify if you...
- Eastern Cooperative Oncology Group Performance Status Grade 2 or higher
- Current or planned cancer treatments in next 6 months (except maintenance hormonal therapy)
- For prostate cancer, currently receiving or previously received 12 or more months of androgen deprivation therapy
- Plans to move out of a rural area within next 6 months
- Presence of medical conditions that prevent safe exercise participation (e.g., recent heart event, COPD)
- History of metabolic diseases like diabetes or uncontrolled thyroid problems (pre-diabetes or diabetes managed only with metformin allowed)
- Currently participating in another exercise oncology program
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person) for eligibility assessment and physician clearance if needed
Duration - 12 weeks
Participants engage in a 12-week telehealth exercise program designed for rural cancer survivors with cancer-related fatigue. Exercise sessions are delivered remotely via videoconferencing and a personal training app. Symptoms are monitored every two weeks by emailed surveys, and additional telehealth sessions may be scheduled if symptom improvement is below expectations.
Videoconference exercise sessions and emailed symptom surveys every 2 weeks, with additional telehealth sessions as needed
Duration - Additional 12 weeks for waitlist control group after initial wait period
Participants complete remote assessments every two weeks to monitor physical function and symptom changes throughout the study period, including waitlist control participants who receive the intervention after 12 weeks.
Remote assessments every 2 weeks
Trial Site Locations
Total: 2 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Montana
Missoula, Montana, United States, 59812
Actively Recruiting
Research Team
J
Jared Scorsone
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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