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Search / Trial NCT07001241

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

Launched by UNIVERSITY OF COLORADO, DENVER · May 23, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Prostate Cancer Exercise Telehealth Breast Cancer Metabolism Physical Function

ClinConnect Summary

This clinical trial is studying a telehealth exercise program aimed at helping cancer survivors living in rural areas who are experiencing cancer-related fatigue (CRF). The program will look at whether regular exercise can improve fatigue levels and physical function in these survivors, specifically those who have had breast or prostate cancer. Participants will be asked to complete a virtual physical assessment before and after the program and will also provide small dried blood samples every two weeks while taking part in the study. Some participants will start the exercise program right away, while others will wait for 12 weeks before beginning, allowing researchers to compare the results.

To be eligible for the trial, participants need to be between 18 and 90 years old, have been diagnosed with breast or prostate cancer, and have completed their treatment at least three months ago. They should also have access to high-speed internet and a device like a smartphone or laptop for virtual sessions. The program includes personalized exercise plans and support from a specialist, and participants will be monitored throughout the trial to ensure their safety. This study can provide valuable insights into how exercise might help improve the quality of life for rural cancer survivors dealing with fatigue.

Gender

ALL

Eligibility 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.

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Missoula, Montana, United States

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Ryan J Marker, PhD, DPT

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported