CanRestoreFunction Cancer-related Fatigue ( CRF ) (CRF)

CanRestoreFunction: Cancer-Related Fatigue Management

The goal of this randomized control trial is to determine if participating in an 8-week online cancer-related fatigue management intervention consisting of individualized exercise program, one-on-one goal setting and action plan development and interactive educational module will significantly reduce the perception of cancer-related fatigue, improve the quality of life, improve perceived cognition, and perceived function of breast cancer compared to a wait-list control group. The aim the project is to determine if an online cancerrelated fatigue management program is associated with 1. A decrease in cancer-related fatigue. 2. An improved perception of their ability and satisfaction in completing important activities 3. Greater quality of life. 4. Improved mobility 5. Improved perceived cognition

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm
• Intervention / Treatment: Behavioral: Exercise, Problem-Solving Session and Education

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Fleischer, Ph.D; Phone Number: 513-558-3732; Email: fleiscae@ucmail.uc.edu
• Study Contact Backup: Name: Mary Fisher, Ph.D; Phone Number: 937-229-5617; Email: Mary.Fisher@udayton.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • Recruiting
      • University of Cincinnati
      • Contact: Anne Fleischer, Ph.D; Phone Number: 513-558-3732; Email: CaRehabResearch@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• been diagnosed with any type of cancer within 5 years of enrollment,
• received chemotherapy and/or radiation therapy
• have access to mobile device or computer
• have basic computer or mobile device skills,
• have a significant level of fatigue defined as >3 on 0-10 scale using the Oneitem Fatigue Scale

Exclusion Criteria:

• have metastatic cancer (Stage 4),
• do not have a signed medical release by their physician or physician extender indicating that the participant can safely participate in the exercise program,
• chronic fatigue prior to cancer diagnosis, such as fibromyalgia
• are unable to follow verbal or written assessment instructions, are non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise, Problem-Solving and Education; Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules	Behavioral: Exercise, Problem-Solving Session and Education; Complete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules
No Intervention: Usual Care; Participants will complete their daily routines as they typically do.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Fatigue Inventory	This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale	Baseline
Brief Fatigue Inventory	This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale	4-week
Brief Fatigue Inventory	This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale	8-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Occupational Performance Measure	The OT administers the COPM, which is 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 separately 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."	Baseline
Canadian Occupational Performance Measure	The OT administers the COPM, which is 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 separately 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."	4-week
Canadian Occupational Performance Measure	The OT administers the COPM, which is 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 separately 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."	8-week
Functional Assessment of Chronic Illness Therapy-Fatigue	This 40-item 5-point Likert scale (0=Not at all 1=A little bit 2=Somewhat 3= Quite a bit 4=Very much) 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	Baseline
Functional Assessment of Chronic Illness Therapy-Fatigue	This 40-item 5-point Likert scale (0=Not at all 1=A little bit 2=Somewhat 3= Quite a bit 4=Very much) 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	4-weeks
Functional Assessment of Chronic Illness Therapy-Fatigue	This 40-item 5-point Likert scale (0=Not at all 1=A little bit 2=Somewhat 3= Quite a bit 4=Very much) 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	8-weeks
PROMIS Cognitive Function Ability 8a	This 8-item 5-point Likert scale [Never, Rarely (Once) Sometimes (Two or three times) Often (About once a day) Very often (Several times a day)] evaluates patient-perceived cognitive abilities, its interference with daily functioning, whether other people observe cognitive impairments, and its impact on quality of life	Baseline
PROMIS Cognitive Function Ability 8a	This 8-item 5-point Likert scale [Never, Rarely (Once) Sometimes (Two or three times) Often (About once a day) Very often (Several times a day)] evaluates patient-perceived cognitive abilities, its interference with daily functioning, whether other people observe cognitive impairments, and its impact on quality of life	4-weeks
PROMIS Cognitive Function Ability 8a	This 8-item 5-point Likert scale [Never, Rarely (Once) Sometimes (Two or three times) Often (About once a day) Very often (Several times a day)] evaluates patient-perceived cognitive abilities, its interference with daily functioning, whether other people observe cognitive impairments, and its impact on quality of life	8-weeks
Promis Applied Cognitive Abilities 8a	This 8-item 5-point Likert scale [Not at all A little bit, Somewhat, Quite a bit, Very much] evaluates the patient-perceived cognitive deficits	Baseline
Promis Applied Cognitive Abilities 8a	This 8-item 5-point Likert scale [Not at all A little bit, Somewhat, Quite a bit, Very much] evaluates the patient-perceived cognitive deficits	4-weeks
Promis Applied Cognitive Abilities 8a	This 8-item 5-point Likert scale [Not at all A little bit, Somewhat, Quite a bit, Very much] evaluates the patient-perceived cognitive deficits	8-weeks
6-minute walk test	Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks	Baseline
6-minute walk test	Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks	4-weeks
6-minute walk test	Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks	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	Baseline
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	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	8-weeks
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 1
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 2
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 3
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 4
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 5
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 6
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 7
Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 8
Average heart rate	Fitbit will track daily heart rate of each participant	Week 1
Average heart rate	Fitbit will track daily heart rate of each participant	Week 2
Average heart rate	Fitbit will track daily heart rate of each participant	Week 3
Average heart rate	Fitbit will track daily heart rate of each participant	Week 4
Average heart rate	Fitbit will track daily heart rate of each participant	Week 5
Average heart rate	Fitbit will track daily heart rate of each participant	Week 6
Average heart rate	Fitbit will track daily heart rate of each participant	Week 7
Average heart rate	Fitbit will track daily heart rate of each participant	Week 8

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: University of Dayton
• Investigators: Principal Investigator: Anne Fleischer, Ph.D, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; exercise; problem-solving; cancer-related fatigue; online interactive education
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: HRP - 503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No