Telehealth exercise program for rural cancer survivors with fatigue
Official title: 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
Run by University of Colorado, Denver · NCT07001241 · Data updated 2026-11-12
This 12-week program will test whether guided telehealth exercise helps rural breast and prostate cancer survivors reduce cancer-related fatigue and improve physical function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | August 2028 |
| Study ends | December 2030 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07001241 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18–89) with a history of breast or prostate cancer who completed curative-intent treatment 3 months to 5 years earlier, live in an HRSA-defined rural area, report at least moderate fatigue (>3/10), and have high-speed internet plus a smartphone or laptop are ideal candidates.
✕Probably not a fit
People who only had surgery (no systemic or radiation/hormonal therapy), those without moderate fatigue, or those lacking reliable internet or compatible devices are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized phase 2 trial compares a 12-week remotely delivered exercise program to a wait-list control in rural breast and prostate cancer survivors with moderate fatigue. The intervention combines scheduled telehealth sessions with cancer exercise specialists, individualized exercise programming via a smartphone/internet app, and symptom monitoring by emailed surveys. Every two weeks participants complete brief virtual physical function assessments and mail in dried blood spot samples to measure metabolic markers including fatty acid oxidation. A subset of up to 40 participants who can travel to study sites will undergo in-person lab testing of acute exercise responses and noninvasive body composition measures.
Why it matters
Potential benefit: If successful, the program could reduce fatigue and improve mobility and daily functioning for rural cancer survivors while being deliverable remotely.
How similar studies have gone: Exercise has been shown in prior trials to reduce cancer-related fatigue and telehealth delivery is feasible, but combining remote metabolic monitoring with a randomized wait-list design in rural survivors is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2. 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.
Where it's running
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting -
University of Montana
Missoula, Montana, United States Recruiting
Study contacts
- Principal investigator: Ryan J Marker, PhD, DPT — University of Colorado, Denver
- Study coordinator: Jared Scorsone
- Email: Jared.Scorsone@cuanschutz.edu
- Phone: 720-724-9601
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.