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Telehealth Exercise Program to Improve Cancer Related Fatigue for Rural Breast or Prostate Cancer Survivors
Trial Status: active
This clinical trial tests how well a telehealth exercise program works to improve cancer related fatigue in rural breast or prostate cancer survivors. Cancer-related fatigue (CRF) is one of the most common and functionally limiting symptoms reported by cancer survivors. Clinically supervised exercise is among the best-known interventions for CRF. Telehealth has enabled the delivery of high-quality exercise interventions with mechanistic assessments to rural populations. The telehealth exercise program may improve CRF for rural breast prostate cancer survivors.
Inclusion Criteria
Age ≥ 18 and < 90 years of age
Diagnosis of breast or prostate cancer
Completion of treatment with curative intent > 3 months prior to and < 5 years from study initiation
Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible
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
Presence of at least moderate fatigue (> 3/10 per National Comprehensive Cancer Network guidelines)
Access to high-speed home internet
Possession of smartphone or laptop with front-facing camera
Capable and willing to give informed consent
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
Exclusion Criteria
Eastern Cooperative Oncology Group (ECOG) performance status grade ≥ 2
Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
* 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
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).
* These conditions are regularly screened for in cancer survivors joining the BfitBwell Cancer Exercise Program and are identified in the PAR-Q+
Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
* 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07001241.
I. Investigate the efficacy of BfitBwell-TP on CRF in rural cancer survivors.
SECONDARY OBJECTIVES:
I. Examine the influence of objective physical function and fatty acid oxidation (FAOx) on CRF remediation during the intervention.
II. Examine the effects of BfitBwell-TP on select patient-reported outcomes (PROs) (quality of life [QoL], anxiety, depression).
III. Examine the effects of BfitBwell-TP on sub-domains of CRF.
TERTIARY/EXPLORATORY:
I. Explore additional biomarkers of CRF remediation through a dynamic exercise metabolic profile.
II. Explore influence of body composition on biomarkers and CRF remediation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive resistance bands and a personalized exercise "prescription" based on activities they enjoy and resources that they have at home. Patients complete personalized exercise sessions via Zoom, over 1 hour, on week 1 and 6. Patients receive access to the TrueCoach application (app) and complete personalized exercise sessions, over 30-60 minutes, for a total of 2 resistance sessions per week and 3 aerobic sessions per week for 12 weeks. Patients receive access to text communication with a cancer exercise specialist via the TrueCoach app for 12 weeks. Patients wear a fitness tracker on study and undergo self collected blood samples and may optionally undergo in-person blood sample collection throughout the study.
ARM II: Patients receive usual care and continue their usual physical activity and exercise habits for 12 weeks. Patients then receive care as described in arm I.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUCHealth University of Colorado Hospital