Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth Exercise Program
BehavioralBfitBwell-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.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Telehealth Exercise ProgramExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline, Week 12Secondary outcomes
1
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 24
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.
Time frame
Baseline, Week 242
Change from Baseline in FACT-G (quality of life) score at Week 12
The Functional Assessment of Cancer Treatment - General scale (FACTG-G) is a common standardized measure of quality of life in cancer survivors. It contains 27 items with total score ranging from 0 to 108, with higher scores indicating better quality of life.
Time frame
Baseline, Week 123
Pattern of change in FACIT-Fatigue (cancer-related fatigue) score during exercise intervention or wait period
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. Scores will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Time frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 124
Change from Baseline in FACT-G (quality of life) score at Week 24
The Functional Assessment of Cancer Treatment - General scale (FACTG-G) is a common standardized measure of quality of life in cancer survivors. It contains 27 items with total score ranging from 0 to 108, with higher scores indicating better quality of life.
Time frame
Baseline, Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov