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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Conserving Surgery; Mastectomy With Reconstruction
• Intervention / Treatment: Other: QuickDASH; Other: BREAST-Q Physical Well-Being

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of recruitment	assessed by frequency data from initial eligibility screening to enrollment	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of protocol delivery	by evaluating survey completion rates and proportion of patients who are being referred to medical interventions.	up to 3 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jonas Nelson, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; assessments; BREAST-Q REACT; 24-184
• Other Study ID Numbers: 24-184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No