RecruitingPhase 2NCT07001241

Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors

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

Sponsor

University of Colorado, Denver

Enrollment

134 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Prostate Cancer Cancer-related Fatigue

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 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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria9

\. 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 Criteria7

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.

Interventions

BEHAVIORALTelehealth Exercise Program

BfitBwell-TP is a 12-week telehealth exercise intervention. Exercise prescriptions are created, personalized, and delivered by Cancer Exercise Specialists. Exercise content is delivered using a combination of videoconference sessions and a commercial personal training application (accessible via smartphone or internet browser). Patient-reported symptoms (specifically cancer-related fatigue) are assessed every two weeks via emailed surveys. Survey scores are compared to a reference chart of predicted improvements during the program, developed from an established clinical exercise oncology program. Additional videoconference sessions are initiated for participants demonstrating lower than expected symptom improvement, with the goal of adapting the current exercise prescription to improve symptom response.