Status:
RECRUITING
Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer-related Fatigue
Breast Cancer
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief Summary
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). Small dried blood samples and measures of phys...
Detailed Description
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). The 12-week program is designed to be delivere...
Eligibility Criteria
Inclusion
- 1\. Age ≥ 18 and \< 90 years of age. 2. Diagnosis of breast or prostate cancer. 3. Cancer treatment criteria: 3a. Completion of treatment with curative intent \> 3 months prior to and \< 5 years from study initiation.
- 3b. Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible.
- 3c. Individuals diagnosed with breast cancer currently receiving maintenance hormonal therapy, with no planned treatment changes in the next six months, are eligible.
- 4\. Home zip code meeting Health Resources \& Services Administration (HRSA) definition of rural (data.hrsa.gov/tools/rural-health).
- 5\. Presence of at least moderate fatigue (\>3/10 per National Comprehensive Cancer Network guidelines).
- 6\. Access to high-speed home internet. 7. Possession of smartphone or laptop with front-facing camera. 8. Capable and willing to give informed consent. 9. Willing to participate in a 12-week telehealth exercise intervention or 12-week waiting period prior to intervention with brief remote physical assessments and dried blood spot collection every 2 weeks.
- 10\. Able and willing to provide contact information for a local support individual to assist with any possible adverse events.
- 11\. Able and willing to provide contact information for a local primary care provider to address medical issues potentially arising during study activities.
- 12\. Able to provide signed physician clearance for exercise if indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) or National Comprehensive Cancer Network exercise safety screening questions.
Exclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
- Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
- 2a. For individuals with a prostate cancer diagnosis, those currently receiving androgen deprivation therapy (ADT), or those who have previously received ≥ 12 months of ADT, are not eligible.
- 3\. Plans to relocate to a non-rural location in the next six months. 4. Presence of a disease or condition that affects the ability of an individual to safely participate in an exercise intervention (e.g. recent cardiac event or chronic obstructive pulmonary disease).
- 4a. These conditions are identified in the PAR-Q+. 5. Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
- 5a. Participants with pre-diabetes, metabolic syndrome, or diabetes managed with metformin only will be eligible, with this variable tracked for later analysis.
- 6\. Current participation in another exercise oncology program.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT07001241
Start Date
December 1 2025
End Date
December 1 2030
Last Update
August 14 2025
Active Locations (2)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
University of Montana
Missoula, Montana, United States, 59812