Breast NeoplasmCRFNCT05868187
CanRestoreFunction Cancer-related Fatigue ( CRF )
A study testing Exercise, Problem-Solving Session and Education in people with Breast Neoplasm, run by University of Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Exercise, Problem-Solving Session and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Breast Neoplasm
- Being tested
- Exercise, Problem-Solving Session and Education
- Keywords
- cancer-related fatigue, breast cancer, exercise, problem-solving, online interactive education
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, Problem-Solving Session and EducationBehavioural
Complete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules
| Study group | Role | What they receive |
|---|---|---|
| Exercise, Problem-Solving and Education | Experimental | Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules Receives: Behavioral: Exercise, Problem-Solving Session and Education |
| Usual Care | No intervention | Participants will complete their daily routines as they typically do. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 8-week
Secondary outcomes (34)
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."
Measured: 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."
Measured: 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."
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8-weeks
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Measured: Baseline
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Measured: 4-weeks
6-minute walk test
Participants completes a 6-minute walk at their chosen pace and with permitted standing rest breaks
Measured: 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
Measured: 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
Measured: 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
Measured: 8-weeks
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 1
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 2
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 3
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 4
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 5
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 6
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 7
Average number of steps
Fitbit will track the number of steps that the participants takes each day
Measured: Week 8
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 1
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 2
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 3
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 4
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 5
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 6
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 7
Average heart rate
Fitbit will track daily heart rate of each participant
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dayton
- Responsible party
- Principal investigator, Anne Fleischer, University of Cincinnati
- Investigators
- Anne Fleischer, Ph.D, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868187
- Sponsor's protocol ID
- HRP - 503
- Acronym
- CRF
- Status last verified
- Dec 2024
- First submitted
- 7 Feb 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CanRestoreFunction: Cancer-Related Fatigue Management
- ClinicalTrials.gov ID
- NCT05868187
- Acronym / sponsor ID
- CRF / HRP - 503
- Conditions
- Breast Neoplasm
- Keywords
- cancer-related fatigue, breast cancer, exercise, problem-solving, online interactive education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- University of Dayton
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise, Problem-Solving and Education | Experimental | Behavioral: Exercise, Problem-Solving Session and EducationIndividualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules |
| Usual Care | No intervention | –Participants will complete their daily routines as they typically do. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise, Problem-Solving Session and EducationComplete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules | Behavioural | Exercise, Problem-Solving and Education |
Primary outcome
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
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
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
34 secondary outcomes
Canadian Occupational Performance Measure
Time frame: Baseline
Canadian Occupational Performance Measure
Time frame: 4-week
Canadian Occupational Performance Measure
Time frame: 8-week
Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: Baseline
Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: 4-weeks
Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: 8-weeks
PROMIS Cognitive Function Ability 8a
Time frame: Baseline
PROMIS Cognitive Function Ability 8a
Time frame: 4-weeks
PROMIS Cognitive Function Ability 8a
Time frame: 8-weeks
Promis Applied Cognitive Abilities 8a
Time frame: Baseline
Promis Applied Cognitive Abilities 8a
Time frame: 4-weeks
Promis Applied Cognitive Abilities 8a
Time frame: 8-weeks
6-minute walk test
Time frame: Baseline
6-minute walk test
Time frame: 4-weeks
6-minute walk test
Time frame: 8-weeks
30 second sit to stand
Time frame: Baseline
30 second sit to stand
Time frame: 4-weeks
30 second sit to stand
Time frame: 8-weeks
Average number of steps
Time frame: Week 1
Average number of steps
Time frame: Week 2
Average number of steps
Time frame: Week 3
Average number of steps
Time frame: Week 4
Average number of steps
Time frame: Week 5
Average number of steps
Time frame: Week 6
Average number of steps
Time frame: Week 7
Average number of steps
Time frame: Week 8
Average heart rate
Time frame: Week 1
Average heart rate
Time frame: Week 2
Average heart rate
Time frame: Week 3
Average heart rate
Time frame: Week 4
Average heart rate
Time frame: Week 5
Average heart rate
Time frame: Week 6
Average heart rate
Time frame: Week 7
Average heart rate
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Fleischer, Ph.D principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Problem-Solving Session and Education in people with Breast Neoplasm, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.