Breast Conserving SurgeryNCT06550401
A Study of the BREAST-Q REACT Tool for People Having Breast Surgery
A study testing BREAST-Q Physical Well-Being and QuickDASH in people with Breast Conserving Surgery and Mastectomy With Reconstruction, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Conserving Surgery, Mastectomy With Reconstruction
- What is being tested?
- BREAST-Q Physical Well-Being and QuickDASH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Aug 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Scheduled to undergo BCS or mastectomy followed by breast reconstruction with tissue expander, autologous tissues, or direct-to-implant, regardless of neoadjuvant chemotherapy or radiation history
- Female sex
- Able to speak and understand English
- ≥18 years of age
- Able to access the patient portal online
Who cannot join
- Patient is male
- Younger than 18 years of age
- Cannot communicate in English
- Recurrent breast cancer
- Patients without access to the internet.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: The BREAST-Q REACT: Examining the Impact of Immediate Patient-reported Outcome Feedback and Interpretation in the Perioperative Period, a Feasibility Study
The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.
- Being tested
- BREAST-Q Physical Well-Being, QuickDASH
- Keywords
- BREAST-Q REACT, assessments, quality of life, 24-184
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREAST-Q Physical Well-BeingOther
This BREAST-Q domain measures pain or tightness and difficulty with mobility, such as lifting arms or running. The preoperative survey contains 10 items, whereas the postoperative survey contains 11 items. Values for BREAST-Q subscales are converted to summary scores, ranging from 0 to 100, via Q-Score software. Higher scores correlate with better patient quality of life. 37 This survey is administered as part of standard care for all patients.
QuickDASHOther
QuickDASH, also known as the Arm and Shoulder Range of Motion survey within MSK Engage is an 11-item survey that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It is currently standard of care for breast cancer surgery patients. It is a valid, reliable, and responsible survey that can be used for clinical and/or research purposes. Higher scores indicate greater disability.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants in the control group will receive the usual feedback from questionnaires completed before and after routine surgery by discussing it with their surgeon Receives: Other: QuickDASH |
| Intervention group | Experimental | Participants in the intervention group will receive feedback using the BREAST-Q REACT tool from questionnaires completed before and after routine surgery, in addition to the usual way by discussing it with their surgeon. Receives: Other: BREAST-Q Physical Well-Being |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of recruitment
assessed by frequency data from initial eligibility screening to enrollment
Measured: up to 3 months
Secondary outcomes (1)
feasibility of protocol delivery
by evaluating survey completion rates and proportion of patients who are being referred to medical interventions.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start9 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Conserving SurgeryStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Nelson, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550401
- Sponsor's protocol ID
- 24-184
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BREAST-Q REACT: Examining the Impact of Immediate Patient-reported Outcome Feedback and Interpretation in the Perioperative Period, a Feasibility Study
- ClinicalTrials.gov ID
- NCT06550401
- Acronym / sponsor ID
- 24-184
- Keywords
- BREAST-Q REACT, assessments, quality of life, 24-184
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Aug 2024 (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 researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: QuickDASHParticipants in the control group will receive the usual feedback from questionnaires completed before and after routine surgery by discussing it with their surgeon |
| Intervention group | Experimental | Other: BREAST-Q Physical Well-BeingParticipants in the intervention group will receive feedback using the BREAST-Q REACT tool from questionnaires completed before and after routine surgery, in addition to the usual way by discussing it with their surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled to undergo BCS or mastectomy followed by breast reconstruction with tissue expander, autologous tissues, or direct-to-implant, regardless of neoadjuvant chemotherapy or radiation history
- Female sex
- Able to speak and understand English
- ≥18 years of age
- Able to access the patient portal online
Key exclusion criteria (5 listed)
- Patient is male
- Younger than 18 years of age
- Cannot communicate in English
- Recurrent breast cancer
- Patients without access to the internet.
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 |
|---|---|---|
| BREAST-Q Physical Well-BeingThis BREAST-Q domain measures pain or tightness and difficulty with mobility, such as lifting arms or running. The preoperative survey contains 10 items, whereas the postoperative survey contains 11 items. Values for BREAST-Q subscales are converted to summary scores, ranging from 0 to 100, via Q-Score software. Higher scores correlate with better patient quality of life. 37 This survey is administered as part of standard care for all patients. | Other | Intervention group |
| QuickDASHQuickDASH, also known as the Arm and Shoulder Range of Motion survey within MSK Engage is an 11-item survey that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It is currently standard of care for breast cancer surgery patients. It is a valid, reliable, and responsible survey that can be used for clinical and/or research purposes. Higher scores indicate greater disability. | Other | Control group |
Primary outcome
feasibility of recruitment
Time frame: up to 3 months
assessed by frequency data from initial eligibility screening to enrollment
1 secondary outcome
feasibility of protocol delivery
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Jonas Nelson, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREAST-Q Physical Well-Being and QuickDASH in people with Breast Conserving Surgery and Mastectomy With Reconstruction, run by Memorial Sloan Kettering Cancer Center at 6 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
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 of recruitment (time frame: up to 3 months). 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 10 Sep 2026.