Telehealth Exercise Program for Fatigue in Cancer Survivors

Recruiting at 1 trial location

Overseen By Jared Scorsone

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must be taking: Maintenance hormonal

Must not be taking: Androgen deprivation

Disqualifiers: ECOG ≥ 2, Metabolic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a telehealth exercise program designed to assist rural cancer survivors experiencing cancer-related fatigue (CRF). The study aims to determine if the program can alleviate fatigue symptoms and track changes in metabolism and physical fitness. Participants will follow a personalized exercise plan through online sessions, using a smartphone or computer to stay connected. Ideal candidates are breast or prostate cancer survivors living in rural areas who completed treatment more than three months ago and still experience moderate fatigue. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially impactful findings.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on maintenance hormonal therapy for breast cancer, you can continue as long as there are no planned changes in the next six months.

What prior data suggests that this telehealth exercise program is safe for cancer survivors?

Research has shown that exercise programs can be safe and beneficial for cancer survivors experiencing fatigue. Many studies have found that regular exercise can reduce side effects like fatigue. A special exercise program, delivered through video calls and online tools, was tested for cancer survivors in rural areas. It proved practical, allowing participants to follow and complete it without major issues.

This program, designed for home use, aims to assist rural survivors who may face challenges in accessing care. It is based on the successful cancer exercise program BfitBwell, which has effectively reduced fatigue.

In previous studies, participants managed the exercise well, with no reports of serious adverse effects. This indicates that the telehealth exercise program is generally safe for participants. If there are any concerns, consulting a healthcare provider before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Exercise Program for cancer-related fatigue because it offers a personalized and accessible approach specifically designed for rural cancer survivors. Unlike standard treatments for fatigue, which often involve in-person sessions and generalized exercise recommendations, this program leverages telehealth technologies like videoconferencing and smartphone apps to deliver tailored exercise plans. By addressing known barriers to exercise participation in rural areas, such as distance and accessibility, this program has the potential to improve engagement and outcomes for participants. Additionally, the program's continuous monitoring and adaptability ensure that if fatigue doesn't improve as expected, interventions can be promptly adjusted, offering a dynamic and responsive treatment option.

What evidence suggests that this telehealth exercise program is effective for cancer-related fatigue?

Research shows that exercise can greatly reduce cancer-related tiredness. Studies have found that telehealth-delivered exercise programs help cancer survivors improve physical abilities and reduce fatigue. One study discovered that nearly half of older adults with cancer improved their ability to stand up from a chair, indicating better strength and endurance. In this trial, participants in the Telehealth Exercise Program arm will receive personalized exercise plans and online sessions with experts, making it easier for cancer survivors in rural areas to access these benefits. This method helps overcome common challenges to exercising in rural locations. ^{2 4 6 7 8}

Who Is on the Research Team?

Ryan J Marker, PhD, DPT

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for rural cancer survivors dealing with fatigue after breast or prostate cancer. Participants should be able to complete virtual assessments and provide dried blood samples every two weeks. They must not change their current physical activity before the exercise program if placed in the wait-list control group.

Inclusion Criteria

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

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

Exclusion Criteria

These conditions are identified in the PAR-Q+

Current participation in another exercise oncology program

Plans to relocate to a non-rural location in the next six months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Wait-list Control

Participants in the control group complete all study measures without changing current physical activity before receiving the full exercise program.

12 weeks

Brief virtual assessments every two weeks

Telehealth Exercise Program

Participants receive a personalized exercise program including virtual sessions and remote exercise programming with a cancer exercise specialist.

12 weeks

Virtual physical assessments before and after the program, brief virtual assessments every two weeks

Follow-up

Participants are monitored for changes in cancer-related fatigue, physical function, and metabolism after the exercise program.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Exercise Program

Trial Overview The study tests a telehealth exercise program's effectiveness on improving fatigue and physical function in rural cancer survivors. It involves virtual sessions with a specialist, at-home exercises, and regular check-ins compared to a wait-list control group who will later receive the same program.

How Is the Trial Designed?

Group I: Telehealth Exercise Program Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Group Active Control 1 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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39793972/

A Novel Telehealth Exercise Program Designed for Rural ... The purpose of this investigation was to assess the feasibility of a novel telehealth exercise program designed specifically for rural survivors of cancer with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07001241

Telehealth Exercise Program Evaluating Fatigue and ... This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF).

3. cancer.jmir.org cancer.jmir.org/2025/1/e56718

Preliminary Effectiveness of a Telehealth-Delivered Exercise ... Nine (47.3%) older adults with cancer had a change in 30-second chair stand scores greater than the MCID of 2 repetitions. Conclusions: Our ...

4. umimpact.umt.edu umimpact.umt.edu/en/publications/a-novel-telehealth-exercise-program-designed-for-rural-survivors-

A Novel Telehealth Exercise Program Designed for Rural ... T1 - A Novel Telehealth Exercise Program Designed for Rural Survivors of Cancer With Cancer-Related Fatigue. T2 - Single-Arm Feasibility Trial.

5. nature.com nature.com/articles/s41598-024-83846-x

Telemedicine-based exercise intervention in cancer survivors Numerous randomized controlled trials have shown that regular exercise can reduce cancer- and treatment-related side effects such as fatigue, ...

6. sciencedirect.com sciencedirect.com/org/science/article/pii/S2369199925000035

A Novel Telehealth Exercise Program Designed for Rural ... The purpose of this investigation was to assess the feasibility of a novel telehealth exercise program designed specifically for rural survivors of cancer with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745508/

Preliminary Effectiveness of a Telehealth-Delivered ... We aimed to evaluate the preliminary effectiveness of a one-on-one, supervised telehealth exercise program on physical function, muscular endurance, balance, ...

8. ctv.veeva.com ctv.veeva.com/study/virtual-exercise-program-to-reduce-cancer-related-fatigue

Virtual Exercise Program to Reduce Cancer Related Fatigue The proposed program will use information on improvements in fatigue from participants in the BfitBwell Cancer Exercise Program to monitor ...