Actively Recruiting

Phase 2
Age: 18Years - 89Years
All Genders
ID07001241

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

Led by University of Colorado, Denver · Updated on 2026-02-05

134

Participants Needed

2

Research Sites

121 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a telehealth exercise program designed for rural cancer survivors experiencing cancer-related fatigue (CRF). This study aims to determine if the program improves CRF and how fatigue, metabolism, and physical function change during the intervention. The study is a randomized controlled trial comparing the exercise program with a wait-list control group, which will receive the program after a 12-week waiting period. The program focuses on breast and prostate cancer survivors who have completed treatment with curative intent within the last five years. The 12-week intervention is delivered entirely remotely through videoconference sessions with cancer exercise specialists and a personal training smartphone or internet application. Participants complete regular symptom monitoring via emailed surveys every two weeks. If fatigue symptoms do not improve as expected, additional telehealth sessions are provided to adjust exercise plans. The wait-list control group maintains their usual physical activity during the initial 12 weeks before receiving the full exercise program. Optional laboratory assessments including treadmill exercise tests and body composition analysis are available at specific study sites before and after the program. Participants will complete virtual physical assessments and provide dried blood samples at home every two weeks throughout the study. These assessments include measures of physical function and fatty acid oxidation. Those able and willing may attend laboratory visits for more detailed exercise and body composition testing. The primary outcome is the change in cancer-related fatigue measured at 12 weeks. Secondary outcomes include quality of life, anxiety and depression, physical function, daily activity, sleep time, and metabolic profiles. The total study duration includes the 12-week intervention or wait period with ongoing monitoring and assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to less than 90 years
  • Diagnosis of breast or prostate cancer
  • Completed cancer treatment with curative intent more than 3 months and less than 5 years before starting the study
  • Cancer treatment included hormonal, radiation, chemotherapy, and/or immunotherapy (surgery only not eligible)
  • For breast cancer, currently receiving maintenance hormonal therapy with no planned changes in next 6 months
  • Home zip code classified as rural by HRSA
  • Moderate or greater fatigue (greater than 3 out of 10)
  • Access to high-speed home internet
  • Own a smartphone or laptop with a front-facing camera
  • Able and willing to provide informed consent
  • Willing to participate in a 12-week telehealth exercise program or 12-week wait period with remote assessments every 2 weeks
  • Able and willing to provide contact info for a local support person
  • Able and willing to provide contact info for a local primary care provider
  • Able to provide signed physician clearance for exercise if indicated by screening questionnaires
Not Eligible

You will not qualify if you...

  • Eastern Cooperative Oncology Group Performance Status Grade 2 or higher
  • Current or planned cancer treatments in next 6 months (except maintenance hormonal therapy)
  • For prostate cancer, currently receiving or previously received 12 or more months of androgen deprivation therapy
  • Plans to move out of a rural area within next 6 months
  • Presence of medical conditions that prevent safe exercise participation (e.g., recent heart event, COPD)
  • History of metabolic diseases like diabetes or uncontrolled thyroid problems (pre-diabetes or diabetes managed only with metformin allowed)
  • Currently participating in another exercise oncology program

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (remote or in-person) for eligibility assessment and physician clearance if needed

Treatment

Duration - 12 weeks

Participants engage in a 12-week telehealth exercise program designed for rural cancer survivors with cancer-related fatigue. Exercise sessions are delivered remotely via videoconferencing and a personal training app. Symptoms are monitored every two weeks by emailed surveys, and additional telehealth sessions may be scheduled if symptom improvement is below expectations.

Videoconference exercise sessions and emailed symptom surveys every 2 weeks, with additional telehealth sessions as needed

Follow-up

Duration - Additional 12 weeks for waitlist control group after initial wait period

Participants complete remote assessments every two weeks to monitor physical function and symptom changes throughout the study period, including waitlist control participants who receive the intervention after 12 weeks.

Remote assessments every 2 weeks

Trial Site Locations

Total: 2 locations

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

2

University of Montana

Missoula, Montana, United States, 59812

Actively Recruiting

Loading map...

Research Team

J

Jared Scorsone

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Similar Trials

Investigating The Role of Key Non-coding RNA(s) in Breast Ca...

Breast Cancer

Actively Recruiting

1 location

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With...

Prostate Cancer

Actively Recruiting

1 location

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Direc...

Metastatic Prostate Cancer

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here