RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-12

Study Completion:2030-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07001241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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. 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). 6. Current participation in another exercise oncology program.

Inclusion Criteria

Exclusion 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.
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.

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.
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).
6. Current participation in another exercise oncology program.

Contacts and Locations

Study Contact

Jared Scorsone

CONTACT

720-724-9601

Jared.Scorsone@cuanschutz.edu

Principal Investigator

Ryan J Marker, PhD, DPT

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

University of Montana

Missoula, Montana, 59812

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Ryan J Marker, PhD, DPT, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-12

Study Completion Date2030-12

Study Record Updates

Study Start Date2025-12

Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
Exercise
Telehealth
Breast Cancer
Metabolism
Physical function

Additional Relevant MeSH Terms

Cancer-related Fatigue
Breast Cancer
Prostate Cancer