Breast CancerNCT05704842
Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
A study testing Exercise in people with Breast Cancer, run by Virtua Health, Inc. at 1 site in United States.
Trial summary
Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 1 Jun 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
- Age > 18 years
- ECOG performance score < 3
- English-speaking
- with sufficient vision/hearing or family support
- Coronary artery disease, if cleared by cardiologist
- Subject must have smart phone, computer or tablet.
- Willingness to be randomized
Who cannot join
- Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).
- Patients with overt evidence of a psychiatric disorder.
- Coronary artery disease, not cleared by cardiologist.
- Contraindication to exercise.
- Chronic fatigue syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Virtua Health
Voorhees Township, New Jersey, 08043
Susan VanLoon, RN, CCRP, 856-247-7382, svanloon@virtua.org
About this study
Official title: Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy
Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.
Read the detailed description
The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform.
Primary Objectives:
- . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
- To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
- To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT.
Secondary Objectives:
- To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
- To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis
- Conditions
- Breast Cancer
- Being tested
- Exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Exercise program
Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. Receives: Behavioral: Exercise |
| Control | No intervention | Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Measured: Baseline
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Measured: Weekly for 12 weeks
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Measured: Month 1 following completion of chemotherapy
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Measured: Month 3 following completion of chemotherapy
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Measured: Month 6 following completion of chemotherapy
Secondary outcomes (5)
To quantify the change over time in PRO-CTCAE derived symptoms
Outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following sale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Measured: Baseline
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Measured: Weekly for 12 weeks
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Measured: Month 1 following completion of chemotherapy
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Measured: Month 3 following completion of chemotherapy
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Measured: Month 6 following completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start22 Dec 2022
- Primary completion22 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virtua Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Carevive Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Priya P Gor, MD, MSCE, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704842
- Sponsor's protocol ID
- IRB-2021-04
- Status last verified
- Apr 2024
- First submitted
- 29 Dec 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy
- ClinicalTrials.gov ID
- NCT05704842
- Acronym / sponsor ID
- IRB-2021-04
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Virtua Health, Inc.University, hospital or other
- Collaborators
- Carevive Systems, Inc.
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Jan 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.
Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.
Detailed description
The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform.
Primary Objectives:
- . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
- To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
- To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT.
Secondary Objectives:
- To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
- To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Behavioral: ExerciseIntervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. |
| Control | No intervention | –Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
- Age > 18 years
- ECOG performance score < 3
- English-speaking
- with sufficient vision/hearing or family support
Key exclusion criteria (5 listed)
- Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).
- Patients with overt evidence of a psychiatric disorder.
- Coronary artery disease, not cleared by cardiologist.
- Contraindication to exercise.
- Chronic fatigue syndrome.
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 |
|---|---|---|
| ExerciseAlso: Exercise programHome-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. | Behavioural | Exercise |
Primary outcome
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Time frame: Baseline
The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Time frame: Weekly for 12 weeks
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Time frame: Month 1 following completion of chemotherapy
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Time frame: Month 3 following completion of chemotherapy
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Time frame: Month 6 following completion of chemotherapy
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
5 secondary outcomes
To quantify the change over time in PRO-CTCAE derived symptoms
Time frame: Baseline
To quantify the change over time in PRO-CTCAE derived symptoms
Time frame: Weekly for 12 weeks
To quantify the change over time in PRO-CTCAE derived symptoms
Time frame: Month 1 following completion of chemotherapy
To quantify the change over time in PRO-CTCAE derived symptoms
Time frame: Month 3 following completion of chemotherapy
To quantify the change over time in PRO-CTCAE derived symptoms
Time frame: Month 6 following completion of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Priya P Gor, MD, MSCE principal investigator
Penn Medicine
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 in people with Breast Cancer, run by Virtua Health, Inc. 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan VanLoon, RN, CCRP (8562477382, svanloon@virtua.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. (time frame: Baseline). The study lists 5 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 5 Apr 2024.