Actively Recruiting

Phase 2
Age: 18Years - 89Years
All Genders
NCT07001241

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

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

134

Participants Needed

2

Research Sites

268 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

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

Official 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 years or older and under 90 years of age.
  • Diagnosis of breast or prostate cancer.
  • Completed cancer treatment with curative intent more than 3 months and less than 5 years before study start.
  • Cancer treatment includes hormonal, radiation, chemotherapy, and/or immunotherapy; surgery only is not eligible.
  • Breast cancer patients currently on maintenance hormonal therapy with no planned treatment changes in the next 6 months are eligible.
  • Home zip code meets HRSA definition of rural.
  • Have at least moderate 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 give 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 information for a local support person.
  • Able and willing to provide contact information 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 (ECOG) Performance Status Grade 2 or higher.
  • Current or planned cancer-related treatments in the next 6 months, except maintenance hormonal therapies.
  • Prostate cancer patients currently receiving androgen deprivation therapy (ADT) or with prior ADT treatment lasting 12 months or more are not eligible.
  • Plans to move to a non-rural area within the next 6 months.
  • Presence of any disease or condition that makes exercise unsafe, such as recent cardiac event or chronic obstructive pulmonary disease.
  • Presence or history of metabolic disease like diabetes or uncontrolled thyroid disorders.
  • Participation in another exercise oncology program at this time.

AI-Screening

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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

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Research Team

J

Jared Scorsone

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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