CanRestoreFunction Cancer-related Fatigue ( CRF ) (CRF)

December 4, 2024 updated by: Anne Fleischer, University of Cincinnati

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brief Fatigue Inventory
Time Frame: Baseline
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
Time Frame: 4-week
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
Time Frame: 8-week
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: Baseline
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
Time Frame: 4-week
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
Time Frame: 8-week
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
Time Frame: Baseline
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
Time Frame: 4-weeks
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
Time Frame: 8-weeks
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
Time Frame: Baseline
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
Time Frame: 4-weeks
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
Time Frame: 8-weeks
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
Time Frame: Baseline
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
Time Frame: 4-weeks
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
Time Frame: 8-weeks
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
Time Frame: Baseline
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Baseline
6-minute walk test
Time Frame: 4-weeks
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
4-weeks
6-minute walk test
Time Frame: 8-weeks
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
8-weeks
30 second sit to stand
Time Frame: Baseline
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
Time Frame: 4-weeks
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
Time Frame: 8-weeks
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
Time Frame: Week 1
Fitbit will track the number of steps that the participants takes each day
Week 1
Average number of steps
Time Frame: Week 2
Fitbit will track the number of steps that the participants takes each day
Week 2
Average number of steps
Time Frame: Week 3
Fitbit will track the number of steps that the participants takes each day
Week 3
Average number of steps
Time Frame: Week 4
Fitbit will track the number of steps that the participants takes each day
Week 4
Average number of steps
Time Frame: Week 5
Fitbit will track the number of steps that the participants takes each day
Week 5
Average number of steps
Time Frame: Week 6
Fitbit will track the number of steps that the participants takes each day
Week 6
Average number of steps
Time Frame: Week 7
Fitbit will track the number of steps that the participants takes each day
Week 7
Average number of steps
Time Frame: Week 8
Fitbit will track the number of steps that the participants takes each day
Week 8
Average heart rate
Time Frame: Week 1
Fitbit will track daily heart rate of each participant
Week 1
Average heart rate
Time Frame: Week 2
Fitbit will track daily heart rate of each participant
Week 2
Average heart rate
Time Frame: Week 3
Fitbit will track daily heart rate of each participant
Week 3
Average heart rate
Time Frame: Week 4
Fitbit will track daily heart rate of each participant
Week 4
Average heart rate
Time Frame: Week 5
Fitbit will track daily heart rate of each participant
Week 5
Average heart rate
Time Frame: Week 6
Fitbit will track daily heart rate of each participant
Week 6
Average heart rate
Time Frame: Week 7
Fitbit will track daily heart rate of each participant
Week 7
Average heart rate
Time Frame: Week 8
Fitbit will track daily heart rate of each participant
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Dayton

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Fleischer, Ph.D, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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