Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors
Recruiting · NCT07001241 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 physical function will be collected throughout the program. The main questions it aims to answer are: * Does the exercise program improve CRF in rural cancer survivors? * How do CRF, metabolism, and physical function change during the exercise program? Researchers will compare the program to a wait-list control group. This group will complete all study measures without without changing current physical activity before receiving the full exercise program. Participants will: * Complete a virtual physical assessment before and after the program. * Complete brief virtual assessments and collect dried blood samples (at home and mailed in) every two weeks during the program. * Receive a personalized exercise program including virtual sessions and remote exercise programming with a cancer exercise specialist (after a 12-week wait period in the wait-list control group). * Optional: Willing participants will visit a study site for a laboratory-based exercise assessment before and after the program.
Who can take part
Inclusion criteria
- \. 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.
- b. Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible.
- c. Individuals diagnosed with breast cancer currently receiving maintenance hormonal therapy, with no planned treatment changes in the next six months, are eligible.
- \. Home zip code meeting Health Resources \& Services Administration (HRSA) definition of rural (data.hrsa.gov/tools/rural-health).
- \. Presence of at least moderate fatigue (\>3/10 per National Comprehensive Cancer Network guidelines).
- \. 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.
- \. Able and willing to provide contact information for a local support individual to assist with any possible adverse events.
- \. Able and willing to provide contact information for a local primary care provider to address medical issues potentially arising during study activities.
- \. 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 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
- Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
- a. 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.
- \. 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).
- a. These conditions are identified in the PAR-Q+. 5. Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
- a. Participants with pre-diabetes, metabolic syndrome, or diabetes managed with metformin only will be eligible, with this variable tracked for later analysis.
- \. Current participation in another exercise oncology program.
Where it is running
4 locations listed across 2 US states.
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States
- University of Montana - Missoula, Montana, United States
- University of Montana - Missoula, Montana, United States