Online Cancer-Related Fatigue Management

Neoplasms Clinical Trial

Official title:

Online Cancer-Related Fatigue Management

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05017597
• Other study ID #: EasternKU
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 2023

Study information

• Verified date: September 2023
• Source: Eastern Kentucky University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Setting: Virtual environment

1. Evaluation and weekly meetings will be provided through Zoom® conferencing system provided by EKU or University of Dayton.

2. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Neoplasms

Intervention

Other:
• Rehabilitation
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..

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Kentucky University	University of Dayton

Country where clinical trial is conducted

United States, 

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum heart rate and target heart rate range	The investigator will calculate the participant's maximum heart rate using the formula 207-.70(age)= maximum heart rate. The prescribed exercise intensity will be based on this calculation. The investigator will then instruct the participant on how to measure their heart rate to monitor their exercise intensity during exercise.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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