Virtual Exercise Program to Reduce Cancer Related Fatigue

Study Overview
=================
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.

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.

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

Conditions
-----------------
Cancer, Cancer-related Problem/Condition, Fatigue

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>= 18 years) cancer survivor treated at the University of Colorado Cancer Center o A maximum age of 80 will be set as virtual exercise may become unsafe as individuals get older. A primary cancer diagnosis of breast, prostate, or lung cancer Current report of moderate-to-severe fatigue (> 3 on a 0-10 scale, per NCCN definition30) Live in rural Colorado (> 1-hour commute to major front range city [Denver, Fort Collins, and Colorado Springs]) Completed medical cancer treatment (chemotherapy and/or radiation) with curative intent within past 12 months. o No additional treatment planned for next 4 months High-speed home internet and smartphone 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-arm pilot interventional trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual exercise program<br>This arm will receive the virtual exercise program. | Behavioral: Exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Steps per day | Average steps per day over a 7 day period, assessed with commercial fitness tracker | Baseline (week 0), 12 weeks | 
| Changes in Average sleep time | 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 participant can stand on one leg, up to 30 s | Baseline (week 0), 12 weeks | 
| Changes in Gait speed | Gait speed over a 4 m distance, in m/s | Baseline (week 0), 12 weeks | 
| Changes in Timed up and go | 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 | Number of times one can stand and sit from a chair in 30 s | Baseline (week 0), 12 weeks | 
| Changes Tecumseh Step Test | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 13-item instrument widely used to assess cancer related fatigue. Score range: 0-52. Lower scores indicate more fatigue. | Baseline (week 0), 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Telehealth, Cancer-related fatigue