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Active, not recruitingNCT06550401Updated Sep 10, 2026

A Study of the BREAST-Q REACT Tool for People Having Breast Surgery

An interventional study of BREAST-Q Physical Well-Being and QuickDASH in Breast Conserving Surgery and Mastectomy With Reconstruction, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 6 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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 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.

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Conditions studied

  • Breast Conserving Surgery
  • Mastectomy With Reconstruction

Keywords

  • BREAST-Q REACT
  • assessments
  • quality of life
  • 24-184
03

In context

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient is male
  • Younger than 18 years of age
  • Cannot communicate in English
  • Recurrent breast cancer
  • Patients without access to the internet.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    Control group

    Participants in the control group will receive the usual feedback from questionnaires completed before and after routine surgery by discussing it with their surgeon

    Other: QuickDASH

  • Experimental
    Intervention group

    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.

    Other: BREAST-Q Physical Well-Being

Interventions

  • OtherBREAST-Q Physical Well-Being

    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.

  • OtherQuickDASH

    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.

06

What researchers measure

Primary outcomes

  1. feasibility of recruitment

    assessed by frequency data from initial eligibility screening to enrollment

    Time frame: 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.

    Time frame: up to 3 months

07

Study locations

6 sites
  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Commack (All Protocol Activities)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau (All Protocol Activities)
    Uniondale, New York 11553, United States
08

References and documents

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06550401
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
Aug 9, 2024
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Jonas Nelson, MD, MPH
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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