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

NCT07001241 | Recruiting Phase 2 DMC

• 2 other identifiers: 24-1398.ccR01CA292482
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12

  The Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) is a common standardized measure of cancer-related fatigue. It contains 13 items with total score ranging from 0 to 52, with higher scores indicating less fatigue.

  Baseline, Week 12

Secondary Outcomes (27)

• Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 24

  Baseline, Week 24

• Change from Baseline in FACT-G (quality of life) score at Week 12

  Baseline, Week 12

• Pattern of change in FACIT-Fatigue (cancer-related fatigue) score during exercise intervention or wait period

  Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12

• Change from Baseline in FACT-G (quality of life) score at Week 24

  Baseline, Week 24

• Change from Baseline in HADS (anxiety and depression) scores at Week 12

  Baseline, Week 12

Study Arms (2)

Telehealth Exercise Program

EXPERIMENTAL

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.

Behavioral: Telehealth Exercise Program

Waitlist Control Group

NO INTERVENTION

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 BEHAVIORAL

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.

Also known as: BfitBwell Telehealth Program (BfitBwell-TP)

Telehealth Exercise Program

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• b. Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible.
• c. Individuals diagnosed with breast cancer currently receiving maintenance hormonal therapy, with no planned treatment changes in the next six months, are eligible.
• \. Home zip code meeting Health Resources \& Services Administration (HRSA) definition of rural (data.hrsa.gov/tools/rural-health).
• \. Presence of at least moderate fatigue (\>3/10 per National Comprehensive Cancer Network guidelines).
• \. 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.
• \. Able and willing to provide contact information for a local support individual to assist with any possible adverse events.
• \. Able and willing to provide contact information for a local primary care provider to address medical issues potentially arising during study activities.
• \. 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.

You may not qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
• Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
• a. 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.
• \. 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).
• a. These conditions are identified in the PAR-Q+. 5. Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
• a. Participants with pre-diabetes, metabolic syndrome, or diabetes managed with metformin only will be eligible, with this variable tracked for later analysis.
• \. Current participation in another exercise oncology program.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Ryan J Marker, PhD, DPT

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared Scorsone

CONTACT

720-724-9601; Jared.Scorsone@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to an intervention group or wait-list control group. Participants in both groups complete all study assessments (primary outcomes). Following all study assessments with no intervention, participants in the wait-list control group will receive the full exercise program.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Following publication of major investigation findings (approximately 2030) through required data storage (approximately 2037).
• Access Criteria: De-identified research data will be made available, upon request, following the publication of major investigation findings. Data will be stored on University of Colorado servers, and user registration will be required to access the data, in accordance with NIH Data Sharing Policy Guidelines. An agreement to the following conditions will be required: 1) data may only be used for research purposes, 2) no attempt will be made to identify research participants, 3) data will be destroyed following analysis completion, and 4) data will not be distributed to third parties. Access to data will be identified in all publications to maintain wide availability to the research community in accordance with University policies and the NIH Principles and Guidelines document.

Locations

US (2)