Virtual Exercise Program for Cancer-Related Fatigue

Overseen By Ryan J Marker, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Orthopedic conditions, Rheumatoid arthritis, Chronic pain, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

19 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this investigation is to establish the feasibility and initial effectiveness of a novel exercise program for rural cancer survivors in Colorado suffering from cancer related fatigue. Participation in an exercise program has regularly been shown to reduce fatigue in cancer survivors, though in-person, supervised participation has a greater effect on fatigue than home-based programs with no supervision. Access to these supervised programs are limited in rural areas, restricting the ability of rural cancer survivors to experience the fatigue-reducing benefits of exercise. The proposed program will use information on improvements in fatigue from participants in the BfitBwell Cancer Exercise Program to monitor improvements in fatigue in rural cancer survivors performing a home exercise program and trigger a telehealth session with a cancer exercise specialist to adapt the exercise prescription when improvements are less than expected. The BfitBwell Program is an established exercise program at the Anschutz Health and Wellness Center which has worked with over 600 cancer survivors and is highly effective at reducing cancer related fatigue. The goal of the program is to replicate the effects of a successful supervised exercise program in rural cancer survivors who do not have access to this type of program. This investigation will recruit 20 rural cancer survivors experiencing fatigue and assess their ability to participate in the program, as well as how well the program improves their fatigue. Interviews will be conducted with participants after the program to determine how future versions of the program could be improved. The investigators anticipate that this program will be feasible and effective, providing preliminary data to pursue a large-scale clinical trial of the program following this project's completion.

Research Team

Ryan Marker, PT, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for rural Colorado cancer survivors under 80 years old who've finished cancer treatment within the last year, are experiencing moderate-to-severe fatigue, and have high-speed internet plus a smartphone. It's not for those with widespread chronic pain, recent heart issues, severe joint problems or lung diseases like COPD.

Inclusion Criteria

I finished my cancer treatment aimed at curing it within the last year.

My cancer is either in the breast, prostate, or lung.

Live in rural Colorado (> 1-hour commute to major front range city [Denver, Fort Collins, and Colorado Springs])

Exclusion Criteria

You have medical conditions that could affect your safety or ability to participate in an exercise program. Some examples include:

My condition is advanced rheumatoid arthritis.

I have severe joint pain, amputations, or injuries that limit my movement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week virtual exercise program with CRF monitoring and telehealth sessions

12 weeks

2 mandatory virtual exercise sessions, up to 5 triggered virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Regular assessments at 6, 9, and 15 months

Treatment Details

Interventions

• Exercise

Trial Overview The study tests a home-based exercise program aimed at reducing fatigue in rural cancer survivors. It uses telehealth to adjust exercises when needed based on the BfitBwell Cancer Exercise Program's success metrics. The goal is to see if this can match supervised programs' benefits.

Participant Groups

Group I: Virtual exercise program Experimental Treatment 1 Intervention

This arm will receive the virtual exercise program.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Cancer League of Colorado

Collaborator

Trials

13

Recruited

450+