Virtual Exercise Program to Reduce Cancer Related Fatigue

July 2, 2025 updated by: University of Colorado, Denver

Feasibility and Effectiveness of an Innovative Exercise Program to Reduce Fatigue in Rural Cancer Survivors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed exercise program utilizes a novel reference chart system to monitor cancer-related fatigue (CRF) and trigger necessary interventions. This reference chart has been developed from CRF data collected in 173 cancer survivors participating in the BfitBwell Program, a highly effective supervised exercise program pioneered at the University of Colorado. The reference chart estimates the continuous trajectory of fatigue improvement during the three-month program. The focus of this study is to extend the benefits of an effective, supervised exercise program to rural Coloradoans via a home exercise program supported by CRF monitoring and symptom-triggered telehealth sessions. Deviations from estimated improvements in CRF will trigger telehealth sessions with a cancer exercise specialist (CES) to adapt the exercise prescription, in real time, as in a supervised program. The intent is to replicate the effects of a supervised exercise program in cancer survivors in rural areas without access to such programs. The feasibility, effectiveness, and design of the program will be assessed with two specific aims.

Aim 1: Determine the feasibility and preliminary effectiveness of the proposed exercise program.

Objective 1a: Assess the enrollment rate of patients able and willing to participate in the program and the adherence of patients enrolled in the program to their prescribed exercise, CRF monitoring, and telehealth session participation.

Objective 1b: Assess the effect of the proposed program on CRF improvements in enrolled participants and compare this effect to that of the supervised BfitBwell exercise program.

Exploratory Objective 1: Assess the feasibility of the semi-continuous remote monitoring of fatigue (ecological momentary assessment) to better tailor the program to more acute changes in CRF.

Aim 2: Assess participant perspectives of barriers and facilitators to participation in the prescribed exercise and CRF monitoring.

Objective 2: Gather qualitative data on barriers and facilitators to participation from all participants enrolling in the program using semi-structured interviews.

This is an innovative program, being the first exercise intervention to implement real time adaptations for rural patients, with decisions anchored against a novel symptom monitoring system. Qualitative data will be collected to improve the next iteration of the program and to inform a future, large-scale clinical trial of program implementation in rural populations. The long-term goal is to develop a feasible and effective exercise program for rural cancer survivors which replicates the benefits of supervised exercise programs to which access may be restricted in rural settings.

This is a prospective, single-arm pilot intervention trial. It will collect objective data on the feasibility and effectiveness of the intervention, as well as qualitative data to inform how the intervention could be improved in future iterations. The exploratory aim will collect data on "in-the-moment" fatigue that could also inform novel future versions of the intervention.

This investigation will recruit adult cancer survivors treated at the University of Colorado Cancer Center (aged 18 years and over) who live in rural Colorado, have completed cancer treatment, and report moderate-to-severe CRF (> 3 on a 0-10 scale, per NCCN definition). Cancer type will be limited to the three types with the highest anticipated new cases in Colorado in 2020: breast, prostate, and lung. Only survivors who have completed medical treatment (chemotherapy and/or radiation), with curative intent, within the past 12 months, and have no additional treatment planned for the next four months, will be recruited. Rural participants will be defined as those who have greater than a 1-hour commute to the major front range cities (Denver, Fort Collins, and Colorado Springs). Participants must have home internet access and smartphones to allow participation in telehealth sessions and remote monitoring of exercise participation and fatigue. Participants with medical conditions that would impact the safety of, or participation in, an exercise program will be excluded. Twenty participants will be recruited in one year, with the goal of retaining at least 15 through the final assessment.

Participants will complete assessments (baseline and final) and exercise sessions virtually. The primary outcome measure will be the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale. Other assessment items will include measures of physical fitness and function. CRF will be assessed by questionnaires every two weeks, and semi-continuously with a smartphone application. The exercise program is 12 weeks long, and includes 2 mandatory virtual exercise sessions, and up to 5 triggered virtual exercise sessions. Participants will be mailed equipment to complete the study upon enrollment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Anschutz Health and Wellness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual exercise program
This arm will receive the virtual exercise program.
Behavioral: Exercise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 12 weeks
Time Frame: Baseline (week 0), 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Steps per day
Time Frame: Baseline (week 0), 12 weeks
Average steps per day over a 7 day period, assessed with commercial fitness tracker
Baseline (week 0), 12 weeks
Changes in Average sleep time
Time Frame: Baseline (week 0), 12 weeks
Average sleep time per day over a 7 day period, assessed with commercial fitness tracker
Baseline (week 0), 12 weeks
Changes in Single limb stance
Time Frame: Baseline (week 0), 12 weeks
Time participant can stand on one leg, up to 30 s
Baseline (week 0), 12 weeks
Changes in Gait speed
Time Frame: Baseline (week 0), 12 weeks
Gait speed over a 4 m distance, in m/s
Baseline (week 0), 12 weeks
Changes in Timed up and go
Time Frame: Baseline (week 0), 12 weeks
Time (in s) to rise from a chair, walk 3 m, turn around, walk back to chair, and sit down
Baseline (week 0), 12 weeks
Changes in 30 s Sit-to-Stand
Time Frame: Baseline (week 0), 12 weeks
Number of times one can stand and sit from a chair in 30 s
Baseline (week 0), 12 weeks
Changes Tecumseh Step Test
Time Frame: Baseline (week 0), 12 weeks
Participants steps on and off an 8" step at a rate of 24 steps/min for 3 min. Heart rate is recorded at 30 s and 1 min after completion.
Baseline (week 0), 12 weeks
Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 12 weeks
Time Frame: Baseline (week 0), 12 weeks
Common questionnaire assessing health related quality of life in cancer survivors, range 0-108, higher scores indicate better quality of life
Baseline (week 0), 12 weeks
Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 6 month
Time Frame: Baseline (week 0), 6 months
Common questionnaire assessing health related quality of life in cancer survivors, range 0-108, higher scores indicate better quality of life
Baseline (week 0), 6 months
Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 9 months
Time Frame: Baseline (week 0), 9 months
Common questionnaire assessing health related quality of life in cancer survivors, range 0-108, higher scores indicate better quality of life
Baseline (week 0), 9 months
Changes in Functional Assessment of Cancer Therapy-General form (FACT-G) at 15 months
Time Frame: Baseline (week 0), 15 months
Common questionnaire assessing health related quality of life in cancer survivors, range 0-108, higher scores indicate better quality of life
Baseline (week 0), 15 months
Changes in Multidimensional Fatigue Inventory (MFI) at 12 weeks
Time Frame: Baseline (week 0), 12 weeks
Questionnaire with multiple subscales of fatigue identified. Score range: 0-100, higher scores indicate increased fatigue
Baseline (week 0), 12 weeks
Changes in Multidimensional Fatigue Inventory (MFI) at 6 months
Time Frame: Baseline (week 0), 6 months
Questionnaire with multiple subscales of fatigue identified. Score range: 0-100, higher scores indicate increased fatigue
Baseline (week 0), 6 months
Changes in Multidimensional Fatigue Inventory (MFI) at 9 months
Time Frame: Baseline (week 0), 9 months
Questionnaire with multiple subscales of fatigue identified. Score range: 0-100, higher scores indicate increased fatigue
Baseline (week 0), 9 months
Changes in Multidimensional Fatigue Inventory (MFI) at 15 months
Time Frame: Baseline (week 0), 15 months
Questionnaire with multiple subscales of fatigue identified. Score range: 0-100, higher scores indicate increased fatigue
Baseline (week 0), 15 months
Changes in Hospital Anxiety and Depression Scale (HADS) at 12 weeks
Time Frame: Baseline (week 0), 12 weeks
Questionnaire to assess anxiety and depression in populations with medical conditions. Score range: 0-42, higher scores indicate presence of anxiety and depression
Baseline (week 0), 12 weeks
Changes in Hospital Anxiety and Depression Scale (HADS) at 6 months
Time Frame: Baseline (week 0), 6 months
Questionnaire to assess anxiety and depression in populations with medical conditions. Score range: 0-42, higher scores indicate presence of anxiety and depression
Baseline (week 0), 6 months
Changes in Hospital Anxiety and Depression Scale (HADS) at 9 months
Time Frame: Baseline (week 0), 9 months
Questionnaire to assess anxiety and depression in populations with medical conditions. Score range: 0-42, higher scores indicate presence of anxiety and depression
Baseline (week 0), 9 months
Changes in Hospital Anxiety and Depression Scale (HADS) at 15 months
Time Frame: Baseline (week 0), 15 months
Questionnaire to assess anxiety and depression in populations with medical conditions. Score range: 0-42, higher scores indicate presence of anxiety and depression
Baseline (week 0), 15 months
Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 12 weeks
Time Frame: Baseline (week 0), 12 weeks
Self-report of time spent in light, moderate, and vigorous physical activity in minutes.
Baseline (week 0), 12 weeks
Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 6 months
Time Frame: Baseline (week 0), 6 months
Self-report of time spent in light, moderate, and vigorous physical activity in minutes.
Baseline (week 0), 6 months
Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 9 months
Time Frame: Baseline (week 0), 9 months
Self-report of time spent in light, moderate, and vigorous physical activity in minutes.
Baseline (week 0), 9 months
Change in Godin Leisure-Time Physical Activity Questionnaire (GLTPAQ) at 15 months
Time Frame: Baseline (week 0), 15 months
Self-report of time spent in light, moderate, and vigorous physical activity in minutes.
Baseline (week 0), 15 months
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 6 months
Time Frame: Baseline (week 0), 6 months
13-item instrument widely used to assess cancer related fatigue. Score range: 0-52. Lower scores indicate more fatigue.
Baseline (week 0), 6 months
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 9 months
Time Frame: Baseline (week 0), 9 months
13-item instrument widely used to assess cancer related fatigue. Score range: 0-52. Lower scores indicate more fatigue.
Baseline (week 0), 9 months
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at 15 months
Time Frame: Baseline (week 0), 15 months
13-item instrument widely used to assess cancer related fatigue. Score range: 0-52. Lower scores indicate more fatigue.
Baseline (week 0), 15 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ecological momentary assessments of fatigue
Time Frame: Semi-continuous throughout program, up to 12 weeks
11 point fatigue intensity scale with higher scores indicating increased fatigue
Semi-continuous throughout program, up to 12 weeks
The Feeling Scale - Pre-exercise
Time Frame: Immediately before each exercise session
11 point scale of perceived affect during exercise, positive scores indicating positive affect, negative scores indicating negative affect
Immediately before each exercise session
The Feeling Scale - Post-exercise
Time Frame: Immediately after each exercise session
11 point scale of perceived affect during exercise, positive scores indicating positive affect, negative scores indicating negative affect
Immediately after each exercise session
Rate of perceived exertion
Time Frame: Immediately after every exercise session
11 point scale of perceived work/intensity during exercise. Higher scores indicate more intense workout.
Immediately after every exercise session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer League of Colorado

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan J Marker, PT, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-2015.cc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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