CanRestoreFunction Cancer-related Fatigue ( CRF )

Breast Neoplasm Clinical Trial

— CRF  

Official title:

CanRestoreFunction: Cancer-Related Fatigue Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868187
• Other study ID #: HRP - 503
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2023
• Source: University of Cincinnati
• Contact: Anne Fleischer, Ph.D
• Phone: 513-558-3732
• Email: fleiscae[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Fatigue

Intervention

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

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	University of Dayton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	6-minute walk test	Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks	Baseline
Secondary	6-minute walk test	Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks	4-weeks
Secondary	6-minute walk test	Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks	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	Baseline
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	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	8-weeks
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 1
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 2
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 3
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 4
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 5
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 6
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 7
Secondary	Average number of steps	Fitbit will track the number of steps that the participants takes each day	Week 8
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 1
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 2
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 3
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 4
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 5
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 6
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 7
Secondary	Average heart rate	Fitbit will track daily heart rate of each participant	Week 8