Breast CancerB-PREPedNCT06081127
Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function
A study testing MOve-ABC in people with Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. 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?
- MOve-ABC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 13 May 2025
- 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
- Patients with newly diagnosed Breast Cancer (BC) (stages 0-4) deemed eligible by the oncology physician team to undergo intent-to-cure treatment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Scale score of 0 (Fully active, able to carry on all pre-disease performance without restriction), 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house- work, office work); or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
- Patients must be Female [Note: Males are not included as BC in males is less than 1% of all cases]
- Patients must be English speaking
- Patients must be age ≥ 18 years
- Patients must have regular access to a mobile phone that can receive text messages and phone calls
- Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration on study
Who cannot join
- Patient with any prior malignancy (except non-melanoma skin)
- Patients with an ECOG Performance Scale score of 3 (Capable of only limited self-care; confined to bed or chair more than 50% of waking hours), 4 (Completely disabled; cannot carry on any self-care; totally confined to bed or chair) or 5 (dead)
- History of pre-existing upper extremity functional impairment, lymphedema, central nervous system damage, other systemic medical condition (e.g. fibromyalgia, rheumatoid arthritis, diabetes)
- Actively receiving physical therapy at the time of recruitment and baseline measurement
- Patients with brain metastasis with adverse events attributable to the metastasis ≥ grade 3
- Patients who are pregnant or lactating
- Patients with any issue that would limit their ability to comply with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery
The goal of this research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. Physical therapy before cancer treatment aims to help with early identification and self-management of physical and functional side effects from cancer treatment. Side effects could be joint pain, muscle weakness, or fatigue that contribute to functional impairment.
The main questions this study aims to answer are:
Read more
- Determine the feasibility (acceptability and suitability) and potential effects of an early intervention called 'Moving On-After Breast Cancer' (MOve-ABC) on physical and functional side effects of cancer compared to enhanced usual care in a large academic medical system to help us refine and adjust the intervention in preparation for a large randomized, double-blinded, controlled trial.
- Determine whether MOve-ABC also affects patient self-management and provider knowledge and behaviors related to detection and management of physical and functional effects associated with cancer.
Participants will be randomly assigned to either of the two arms of the study which are 'Intervention' and 'Enhanced usual care.'
Participants in the intervention arm will receive:
- Planned care per their oncology physician team plus: 1.1. Patient education on physical function in breast cancer 1.2. Physical therapy evaluation 1.3. Individualized home exercise prescription 1.4. Education materials in the form of a study booklet, study website, text messaging, and phone calls 1.5. Monthly monitoring of physical and functional survey scores to identify the need for physical therapy and provide referrals as needed
Participants in the enhanced usual care arm will receive:
- Planned care per their oncology physician team plus 1.2. Monthly monitoring of their physical functional scores to identify the need for physical therapy and provide referrals as needed
All participants will attend three in-person visits for clinical measurements.
- Conditions
- Breast Cancer
- Being tested
- MOve-ABC, Enhanced Usual Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOve-ABCOther
The intervention is called Moving On After Breast Cancer (MOve-ABC) and includes:
- Three in-person visits for clinical measurements
- Enhanced usual care (EUC)
- Pre-hab (Pre-Treatment (PT) evaluation and individualized home therapeutic exercise prescription with safe progressions).
- Teach Back (HEP, post-op movement precautions)
- Self-management education with reinforcement check-ins via text messaging and phone calls at regular intervals.
Enhanced Usual CareOther
All patients will receive EUC. However, half of our sample will have only EUC consisting of
- Three in-person visits for clinical measurements
- Planned oncology treatment (surgery, chemotherapy, radiation)
- Nursing education on surgical site and drain care, post-operative movement precautions, pain management
- If needed, laboratory and radiological testing to rule out disorders that interfere with treatment outcomes
- Monthly monitoring with Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) surveys beginning at baseline with alerts from scores = or < 45 (indicating moderate or severe impairment) for physical therapy referral
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC). Receives: Other: MOve-ABC |
| Enhanced Usual Care (EUC) | Experimental | All patients will receive EUC. However, participants assigned to this arm will have only EUC. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in terms of percentage of participants completing the study protocol
Measured: Through study completion, an average of one year
Number of study participants with a score of less than 45 on the "Patient Reported Outcome Measurement Information System Physical Function Custom Form v2.0 Computerized Patient Reported Outcomes"
This questionnaire is a patient reported outcome measure to assess physical function status. The scores range from 23.9 to 58. Higher the score, higher is the physical function.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6
Secondary outcomes (1)
Average of all scores across the 6-items of Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale
Scoring for each item is on a 1-10 scale where 1 is 'Not at all confident' and 10 is 'Totally Confident.' There are 6 such items. The scores of all the 6 items are combined and averaged to get the total score. The final score is between 1-10. Higher scores indicate higher self-efficacy.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Nov 2023
- Primary completion13 May 2025
- Study completion13 May 2025
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.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Medicine
- Responsible party
- Principal investigator, Ann Marie Flores, Northwestern University
- Investigators
- Ann Marie Flores, PT, MSPT, MA, PhD, CLT, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081127
- Sponsor's protocol ID
- STU00218105
- Acronym
- B-PREPed
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2023
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery
- ClinicalTrials.gov ID
- NCT06081127
- Acronym / sponsor ID
- B-PREPed / STU00218105
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Medicine
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 13 Oct 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 research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. Physical therapy before cancer treatment aims to help with early identification and self-management of physical and functional side effects from cancer treatment. Side effects could be joint pain, muscle weakness, or fatigue that contribute to functional impairment.
The main questions this study aims to answer are:
- Determine the feasibility (acceptability and suitability) and potential effects of an early intervention called 'Moving On-After Breast Cancer' (MOve-ABC) on physical and functional side effects of cancer compared to enhanced usual care in a large academic medical system to help us refine and adjust the intervention in preparation for a large randomized, double-blinded, controlled trial.
- Determine whether MOve-ABC also affects patient self-management and provider knowledge and behaviors related to detection and management of physical and functional effects associated with cancer.
Participants will be randomly assigned to either of the two arms of the study which are 'Intervention' and 'Enhanced usual care.'
Participants in the intervention arm will receive:
- Planned care per their oncology physician team plus: 1.1. Patient education on physical function in breast cancer 1.2. Physical therapy evaluation 1.3. Individualized home exercise prescription 1.4. Education materials in the form of a study booklet, study website, text messaging, and phone calls 1.5. Monthly monitoring of physical and functional survey scores to identify the need for physical therapy and provide referrals as needed
Participants in the enhanced usual care arm will receive:
- Planned care per their oncology physician team plus 1.2. Monthly monitoring of their physical functional scores to identify the need for physical therapy and provide referrals as needed
All participants will attend three in-person visits for clinical measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MOve-ABCPatients assigned to the intervention arm will receive the intervention named Moving On After Breast Cancer (MOve-ABC). |
| Enhanced Usual Care (EUC) | Experimental | Other: Enhanced Usual CareAll patients will receive EUC. However, participants assigned to this arm will have only EUC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with newly diagnosed Breast Cancer (BC) (stages 0-4) deemed eligible by the oncology physician team to undergo intent-to-cure treatment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Scale score of 0 (Fully active, able to carry on all pre-disease performance without restriction), 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house- work, office work); or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
- Patients must be Female [Note: Males are not included as BC in males is less than 1% of all cases]
- Patients must be English speaking
- Patients must be age ≥ 18 years
Key exclusion criteria (7 listed)
- Patient with any prior malignancy (except non-melanoma skin)
- Patients with an ECOG Performance Scale score of 3 (Capable of only limited self-care; confined to bed or chair more than 50% of waking hours), 4 (Completely disabled; cannot carry on any self-care; totally confined to bed or chair) or 5 (dead)
- History of pre-existing upper extremity functional impairment, lymphedema, central nervous system damage, other systemic medical condition (e.g. fibromyalgia, rheumatoid arthritis, diabetes)
- Actively receiving physical therapy at the time of recruitment and baseline measurement
- Patients with brain metastasis with adverse events attributable to the metastasis ≥ grade 3
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 |
|---|---|---|
| MOve-ABCThe intervention is called Moving On After Breast Cancer (MOve-ABC) and includes: 1. Three in-person visits for clinical measurements 2. Enhanced usual care (EUC) 3. Pre-hab (Pre-Treatment (PT) evaluation and individualized home therapeutic exercise prescription with safe progressions). 4. Teach Back (HEP, post-op movement precautions) 5. Self-management education with reinforcement check-ins via text messaging and phone calls at regular intervals. | Other | Intervention |
| Enhanced Usual CareAll patients will receive EUC. However, half of our sample will have only EUC consisting of 1. Three in-person visits for clinical measurements 2. Planned oncology treatment (surgery, chemotherapy, radiation) 3. Nursing education on surgical site and drain care, post-operative movement precautions, pain management 4. If needed, laboratory and radiological testing to rule out disorders that interfere with treatment outcomes 5. Monthly monitoring with Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) surveys beginning at baseline with alerts from scores = or < 45 (indicating moderate or severe impairment) for physical therapy referral | Other | Enhanced Usual Care (EUC) |
Primary outcome
Feasibility in terms of percentage of participants completing the study protocol
Time frame: Through study completion, an average of one year
Number of study participants with a score of less than 45 on the "Patient Reported Outcome Measurement Information System Physical Function Custom Form v2.0 Computerized Patient Reported Outcomes"
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6
This questionnaire is a patient reported outcome measure to assess physical function status. The scores range from 23.9 to 58. Higher the score, higher is the physical function.
1 secondary outcome
Average of all scores across the 6-items of Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale
Time frame: Baseline, Month 3, Month 6
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 30 Dec 2025.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Ann Marie Flores, PT, MSPT, MA, PhD, CLT principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOve-ABC in people with Breast Cancer, run by Northwestern University 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 7 inclusion and 7 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 30 Dec 2025. 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?
Feasibility in terms of percentage of participants completing the study protocol (time frame: Through study completion, an average of one year). The study lists 2 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 30 Dec 2025.