Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors
NCT ID: NCT07001241
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
134 participants
INTERVENTIONAL
2025-12-31
2030-12-31
Brief Summary
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* 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.
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Detailed Description
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Possible mechanisms of action are assessed throughout the program (every two weeks) using accessible methods (Aim 2). Fatty acid oxidation is measured via dried blood spots collected remoted and mailed to the primary study site. Physical function is measured via brief telehealth assessments.
Changes in molecular responses to acute exercise and changes in body composition will be explored in a controlled laboratory assessment in participants able and willing to travel to participating sites (N=40, Aim 3). Small blood samples are collected before and after a standardized treadmill exercise session. Body composition is measured non-invasively in a small chamber using air displacement. This laboratory assessment occurs before and after the program (or wait period).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Telehealth Exercise Program
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.
Telehealth Exercise Program
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.
Waitlist Control Group
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).
No interventions assigned to this group
Interventions
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Telehealth Exercise Program
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
89 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Ryan J Marker, PhD, DPT
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Montana
Missoula, Montana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-1398.cc
Identifier Type: -
Identifier Source: org_study_id
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