Online Cancer-Related Fatigue Management

NCT05017597 | Withdrawn

• 1 other identifier: EasternKU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms; Fatigue

Keywords

Function; Fatigue; Occupation; Exercise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• One Item Fatigue Scale

  Change from baseline measure at 8 weeks

• FACIT-Fatigue

  Change from Baseline measure at 8 weeks

• 6-minute walk test

  Change from baseline measure at 4 weeks

• 6-minute walk test

  Change from 4 week measure at 8 weeks

• 30-second Sit to Stand

  Change from baseline measure at 4 weeks

Other Outcomes (1)

• Maximum heart rate and target heart rate range

  Baseline

Study Arms (1)

Fatigue management

EXPERIMENTAL

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

Interventions

Rehabilitation OTHER

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..

Fatigue management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Kentucky University: lead
• University of Dayton: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

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MeSH Terms

Conditions

Neoplasms; Fatigue; Motor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anne Fleischer, Ph.D

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: August 24, 2021
• Study Start: March 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)