- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533165
Virtual Exercise Program to Reduce Cancer Related Fatigue
Feasibility and Effectiveness of an Innovative Exercise Program to Reduce Fatigue in Rural Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ryan J Marker, PT, PhD
- Phone Number: 6074255755
- Email: ryan.marker@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Anschutz Health and Wellness
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: Virtual exercise program
This arm will receive the virtual exercise program.
|
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
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan J Marker, PT, PhD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2015.cc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown