Online Cancer-Related Fatigue Management

Study Overview
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Brief Summary
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Many individuals who have had cancer experience functional limitations during and after their treatments. The most common side effect from cancer treatment that restricts cancer survivors' completion of daily activities is cancer-related fatigue. Here, we propose to investigate whether an interprofessional approach that targets physiologic, psychologic, and ecological factors will minimize cancer-related fatigue and enhance daily life participation for volunteer cancer survivors living in the community. The interprofessional team will include occupational therapy professor and students from Eastern Kentucky University (EKU), physical therapy and dietitian professors and their students from the University of Dayton, and instructional design instructor from EKU. The approach will include (1) individualized exercise programs-via physical therapy; (2) problem-solving strategies including modifying the environment or activity -via occupational therapy; (3) goal development via physical and occupational therapy; and (4) cancer-related fatigue education via instructional design. We hypothesize that this approach will result in participants experiencing less fatigue, increasing their mobility, improving their quality of life, and being more satisfied with how they perform daily activities.

Detailed Description
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Setting: Virtual environment Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton. Educational and Exercise Videos will be accessed within an individual webpage for each participant within the study's website. Research Design Pre-test/Post-test quasi-experimental design without a control group. This research design will allow us to assess if there is a change in the level of fatigue, mobility, quality of life, and/or perceived performance and satisfaction of important activities Screening Individuals who are interested in participating will contact the Occupational Therapy professor--principal investigator (PI) or Physical Therapy professor-collaborator (CL). PI or CL will contact the potential participant either by telephone or email. Within this initial communication, the potential participant will be provided with the following information: time commitment, type of evaluations, and intervention. If the participant continues to be interested, an electronic inclusion criteria screen will be sent. If all inclusion criteria are met, PI or CL will ask the participant for their physician contact information so a medical release form can be sent to them. Physician medical release A release form will be faxed, sent electronically, or mailed to participant's oncology or primary care provider. Once this signed release is received, we will send an electronic version of the informed consent to the potential participant and schedule a time to review it and a tentative time for the initial evaluation. Initial, Weekly, 4-week, and 8-week Standard of Care Cancer Survivor Evaluations Initial Evaluations After the participant agrees to take part in the study and signs the informed consent, the initial evaluation including questionnaires and physical therapy and occupational therapy assessments within one to two visits will be administered by physical therapy and occupational therapy students (PTSI and OTSI). Assessments will be recorded and reviewed by the supervising therapy professor to ensure assessments are performed using standardized methods. After the assessment eight weekly meetings will be schedule. Estimated length of weekly meeting is 20-30 minutes. Each exercise session is 30-45 minutes in length depending on which level of exercise the participant is completing. The participant will complete 3 sessions each week. Each participant will be provided their own webpage, which can only be accessed by them and the researchers. Within the webpage, the researchers will store the prescribed exercise program, including handouts, video and exercise log, and the problem-solving session goals and action plans. Links to the Cancer-Related Fatigue (CRF) educational modules, as they are assigned to the participant will be posted as well.

Official Title
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Online Cancer-Related Fatigue Management

Conditions
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Neoplasms, Fatigue

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed treatment for a cancer diagnosis within 5 years of enrollment Access to mobile device or computer Basic computer or mobile device skills Experience a significant level of fatigue defined as >= 4 on 0-10 scale using the One-item Fatigue Scale. Exclusion Criteria: Currently undergoing chemotherapy or radiation treatment Unwilling to participate in an exercise program Have metastatic cancer (Stage 4) Do not have physician consent to participate in the exercise program Unable to follow verbal or written assessment instructions Non-English speaking.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fatigue management<br>Prescribed exercises by Physical Therapy Problem-Solving Sessions to resume activities that ther person needs to do, wants to do or is expected to do. Four online educational modules: What is Cancer-Related Fatigue? Nutrition, Sleep Hygiene and Exercise | Other: Rehabilitation<br>* Exercises completed, and rate of perceived exertion (RPE) will be reviewed during & after each exercise session. Exercises will be modified by either increasing or decreasing the intensity. Decisions will be made based RPE, physical symptoms & any identified barriers or supports. Weeks 1, 3, 5, & 7, Cancer-related fatigue (CRF) education will be assigned. During weeks 2, 4, 6, & 8, CRF education will be reviewed and a plan for how to apply the information will be developed. Participant will be guided through 6 steps of problem solving to address one occupational performance problem identified by participant within Canadian Occupational Performance Measure. Goal & action plan for the week will be shared with the participant electronically. At the beginning of each session, participant will describe progress on previous week action plan. Based on participant's response, either a new goal will be developed or the current one modified..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatiue Level: Brief Fatigue Inventory | This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale | Change from Baseline measure at 4 weeks | 
| Change in Fatiue Level: Brief Fatigue Inventory | This 9-item scale assesses the severity and interference of fatigue on a 0 (no fatigue) to 10 (greatest fatigue) scale | Change from 4 week measure at 8 weeks | 
| Perceived Functional Change: Canadian Occupational Performance Measure | a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates no importance and 10 indicates very important. Then the participant rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that they are not able to perform or they are not satisfied and 10 indicates that they are able to perform the activity well or they are very satisfied. This is repeated for how satisficed with how they currently perform each important activity. | Change from Baseline measure at 4 weeks | 
| Perceived Functional Change: Canadian Occupational Performance Measure | a semi-structured interview to understand the routine activities that the participant completes daily, specifically their self-care, leisure, and social activities. The participant rates the importance of each of the activities using a 0 to 10 scale. Zero indicates no importance and 10 indicates very important. Then the participant rates their perception of how well they currently perform each of the important activities and how satisfied they are with their performance using a 0 to 10 scale. Zero indicates that they are not able to perform or they are not satisfied and 10 indicates that they are able to perform the activity well or they are very satisfied. This is repeated for how satisficed with how they currently perform each important activity. | Change from 4 week measure at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One Item Fatigue Scale | Participants answer the following question: How would you rate your fatigue on a scale of 0 to10 with 0 being 'no fatigue' and 10 being the 'worst possible fatigue' | Change from baseline measure at 8 weeks | 
| FACIT-Fatigue | This 40-item 5-point Likert scale evaluates quality of life in individuals with fatigue as measured in 5 domains: physical, social/family, emotional, functional well-being, and fatigue. Higher scores reflect greater quality of life | Change from Baseline measure at 8 weeks | 
| 6-minute walk test | Participants will complete a 6-minute walk at their chosen pace, using assistive devices if needed and with permitted standing rest breaks. Participants will be required to measure the length of a hallway, sidewalk, or driveway where they will be walking. They will then walk for 6 minutes. Participants will report the distance walked as well as the number of rest breaks taken during the 6 minutes. | Change from baseline measure at 4 weeks | 
| 6-minute walk test | Participants will complete a 6-minute walk at their chosen pace, using assistive devices if needed and with permitted standing rest breaks. Participants will be required to measure the length of a hallway, sidewalk, or driveway where they will be walking. They will then walk for 6 minutes. Participants will report the distance walked as well as the number of rest breaks taken during the 6 minutes. | Change from 4 week measure at 8 weeks | 
| 30-second Sit to Stand | Participants are seated in a standard height fixed chair without armrests, which is placed against a wall. They will move from sitting to standing and back to sitting position, with arms crossed against chest. The number of complete stands and sits (1 repetition) will be counted by the investigator and the participant within 30 seconds | Change from baseline measure at 4 weeks | 
| 30-second Sit to Stand | Participants are seated in a standard height fixed chair without armrests, which is placed against a wall. They will move from sitting to standing and back to sitting position, with arms crossed against chest. The number of complete stands and sits (1 repetition) will be counted by the investigator and the participant within 30 seconds | Change from 4 week measure at 8 weeks | 
| Borg Perceived Exertion 6-20 scale | This scale allows participants to rate their perceived exertion during physical activity. Patients will be instructed to rate their level of exertion during their home exercise program and at the conclusion of each session. This will be recorded on their weekly exercise log. | Change from baseline measure to 4 weeks | 
| Borg Perceived Exertion 6-20 scale | This scale allows participants to rate their perceived exertion during physical activity. Patients will be instructed to rate their level of exertion during their home exercise program and at the conclusion of each session. This will be recorded on their weekly exercise log. | Change from 4 week measure to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Function, Fatigue, Occupation, Exercise