Recruiting
Phase 2

Exercise Program

Sponsor:

University of Colorado, Denver

Code:

NCT07001241

Conditions

Cancer-related Fatigue

Breast Cancer

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Telehealth Exercise Program

Study Details

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 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.

Conditions

Cancer-related Fatigue

Breast Cancer

Prostate Cancer

Study ID

NCT07001241

Start date

Oct 8, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Telehealth Exercise Program

The BfitBwell-TP (Telehealth Program) intervention is designed specifically for rural cancer survivors with cancer-related fatigue (CRF). It is personalized to each participant, addresses known barriers to exercise participation in rural survivors, and incorporates the experience and infrastructure of the established clinical BfitBwell Cancer Exercise Program. BfitBwell-TP is delivered completely via existing and accessible telehealth technologies including: videoconference sessions with a cancer exercise specialist, exercise programming and text communication using a personal training smartphone/internet application, and emailed surveys. CRF is assessed throughout the program with additional telehealth sessions initiated if it does not improve as predicted based on a reference chart developed with BfitBwell data.

no intervention: Waitlist Control Group

This group will be instructed to not change their current physical activity and exercise routines while completing all study assessments (including brief assessments every two weeks). After completing a final assessment following the 12-week wait period, they will receive the full exercise intervention (see Experimental Arm for description).

Interventions

Telehealth 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.

Primary outcome measure

  • Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12 [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Ryan J Marker, PhD, DPT

University of Montana

Recruiting

Missoula, Montana, United States, 59812

Contacts

Principal Investigator:

John C Quindry, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Prostate Cancer
  • Exercise
  • Telehealth
  • Breast Cancer
  • Metabolism
  • Physical function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-05.