Virtual Exercise Program to Reduce Cancer Related Fatigue

NCT04533165 | Active Not Recruiting DMC

• 1 other identifier: 20-2015.cc
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Cancer-related Problem/Condition; Fatigue

Keywords

Exercise; Telehealth; Cancer-related fatigue

Outcome Measures

Primary Outcomes (1)

• Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 12 weeks

  13-item instrument widely used to assess cancer related fatigue. Score range: 0-52. Lower scores indicate more fatigue.

  Baseline (week 0), 12 weeks

Secondary Outcomes (26)

• Changes in Steps per day

  Baseline (week 0), 12 weeks

• Changes in Average sleep time

  Baseline (week 0), 12 weeks

• Changes in Single limb stance

  Baseline (week 0), 12 weeks

• Changes in Gait speed

  Baseline (week 0), 12 weeks

• Changes in Timed up and go

  Baseline (week 0), 12 weeks

Other Outcomes (4)

• Ecological momentary assessments of fatigue

  Semi-continuous throughout program, up to 12 weeks

• The Feeling Scale - Pre-exercise

  Immediately before each exercise session

• The Feeling Scale - Post-exercise

  Immediately after each exercise session

Study Arms (1)

Virtual exercise program

EXPERIMENTAL

This arm will receive the virtual exercise program.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

12 week exercise prescription targeting 3 days of at least 30 min of aerobic exercise and 2 days of resistance exercise per week. Adapted to individual abilities, goals, and needs. Exercise intensity targets a 6-7 out of 10 on a 0-10 rate of perceived exertion scale.

Virtual exercise program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>= 18 years) cancer survivor.
• A maximum age of 80 will be set as virtual exercise may become unsafe as individuals get older.
• A cancer diagnosis of any type
• CRF is a common symptom across cancer types and the current CRF reference chart was developed using data from patients with all cancer types.
• Current report of moderate-to-severe fatigue (\> 3 on a 0-10 scale, per NCCN definition31)
• Live in rural Colorado and surrounding areas (\> 1-hour commute to major front range city \[Denver, Fort Collins, and Colorado Springs\])
• This program attempts to target individuals in Colorado and surrounding areas with restricted access to fitness centers that may offer cancer specific services, most likely found in major front range cities. We have defined rural in terms of commute time to these cities, as it is the commute to these centers that restricts access.
• Completed medical cancer treatment (chemotherapy and/or radiation) with curative intent within past 12 months or currently on treatment with no planned changes for the next 4 months (e.g. maintenance or palliative therapy).
• No additional treatment planned for next 4 months.
• These restrictions are made to ensure the validity of tracking changes with the established reference chart, which was developed using data from cancer survivors who had recently completed therapy or were on therapy14. It is unclear how fatigue response to exercise may change in survivors further out from treatment completion.
• High-speed home internet and smartphone (or laptop with camera).

You may not qualify if:

• \- Medical conditions that would impact the safety of, or participation in, an exercise program. This includes:
• Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility- limiting acute orthopedic injuries
• Advanced rheumatoid arthritis
• Widespread chronic pain conditions such as fibromyalgia
• Significant balance impairment increasing the risk of falling
• Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplemental oxygen
• Known cardiovascular disease, uncontrolled hypertension, or new cardiac event within the past 6 months.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (1)

Anschutz Health and Wellness

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Marker RJ, Kittelson AJ, Scorsone JJ, Moran IA, Quindry JC, Leach HJ. A Novel Telehealth Exercise Program Designed for Rural Survivors of Cancer With Cancer-Related Fatigue: Single-Arm Feasibility Trial. JMIR Cancer. 2025 Jan 10;11:e59478. doi: 10.2196/59478.

  PMID: 39793972 DERIVED

MeSH Terms

Conditions

Neoplasms; Fatigue; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ryan J Marker, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm pilot interventional trial

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 31, 2020
• Study Start: November 11, 2021
• Primary Completion: April 12, 2023
• Study Completion: May 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)