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CanRestoreFunction Cancer-related Fatigue ( CRF ) (CRF)

Primary Purpose

Breast Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise, Problem-Solving Session and Education
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm focused on measuring cancer-related fatigue, breast cancer, exercise, problem-solving, online interactive education

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise, Problem-Solving and Education

Usual Care

Arm Description

Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules

Participants will complete their daily routines as they typically do.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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."
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."
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."
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
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
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
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
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
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
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
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
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
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
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
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
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
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant
Average heart rate
Fitbit will track daily heart rate of each participant

Full Information

First Posted
February 7, 2023
Last Updated
May 11, 2023
Sponsor
University of Cincinnati
Collaborators
University of Dayton
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1. Study Identification

Unique Protocol Identification Number
NCT05868187
Brief Title
CanRestoreFunction Cancer-related Fatigue ( CRF )
Acronym
CRF
Official Title
CanRestoreFunction: Cancer-Related Fatigue Management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
University of Dayton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
cancer-related fatigue, breast cancer, exercise, problem-solving, online interactive education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise, Problem-Solving and Education
Arm Type
Experimental
Arm Description
Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will complete their daily routines as they typically do.
Intervention Type
Behavioral
Intervention Name(s)
Exercise, Problem-Solving Session and Education
Intervention Description
Complete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules
Primary Outcome Measure Information:
Title
Brief Fatigue Inventory
Description
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time Frame
Baseline
Title
Brief Fatigue Inventory
Description
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time Frame
4-week
Title
Brief Fatigue Inventory
Description
This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale
Time Frame
8-week
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
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."
Time Frame
Baseline
Title
Canadian Occupational Performance Measure
Description
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."
Time Frame
4-week
Title
Canadian Occupational Performance Measure
Description
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."
Time Frame
8-week
Title
Functional Assessment of Chronic Illness Therapy-Fatigue
Description
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
Time Frame
Baseline
Title
Functional Assessment of Chronic Illness Therapy-Fatigue
Description
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
Time Frame
4-weeks
Title
Functional Assessment of Chronic Illness Therapy-Fatigue
Description
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
Time Frame
8-weeks
Title
PROMIS Cognitive Function Ability 8a
Description
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
Time Frame
Baseline
Title
PROMIS Cognitive Function Ability 8a
Description
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
Time Frame
4-weeks
Title
PROMIS Cognitive Function Ability 8a
Description
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
Time Frame
8-weeks
Title
Promis Applied Cognitive Abilities 8a
Description
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
Time Frame
Baseline
Title
Promis Applied Cognitive Abilities 8a
Description
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
Time Frame
4-weeks
Title
Promis Applied Cognitive Abilities 8a
Description
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
Time Frame
8-weeks
Title
6-minute walk test
Description
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Time Frame
Baseline
Title
6-minute walk test
Description
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Time Frame
4-weeks
Title
6-minute walk test
Description
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Time Frame
8-weeks
Title
30 second sit to stand
Description
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
Time Frame
Baseline
Title
30 second sit to stand
Description
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
Time Frame
4-weeks
Title
30 second sit to stand
Description
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
Time Frame
8-weeks
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 1
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 2
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 3
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 4
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 5
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 6
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 7
Title
Average number of steps
Description
Fitbit will track the number of steps that the participants takes each day
Time Frame
Week 8
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 1
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 2
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 3
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 4
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 5
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 6
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 7
Title
Average heart rate
Description
Fitbit will track daily heart rate of each participant
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Fleischer, Ph.D
Phone
513-558-3732
Email
fleiscae@ucmail.uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Fisher, Ph.D
Phone
937-229-5617
Email
Mary.Fisher@udayton.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Fleischer, Ph.D
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Fleischer, Ph.D
Phone
513-558-3732
Email
CaRehabResearch@gmail.com

12. IPD Sharing Statement

Learn more about this trial

CanRestoreFunction Cancer-related Fatigue ( CRF )

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