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NCT Number: NCT06550401

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Conserving Surgery Mastectomy With Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BREAST-Q Physical Well-Being

Other

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.

QuickDASH

Other

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.

Primary outcomes

  1. feasibility of recruitment

    Time frame: up to 3 months

    assessed by frequency data from initial eligibility screening to enrollment

Secondary outcomes

  1. feasibility of protocol delivery

    Time frame: up to 3 months

    by evaluating survey completion rates and proportion of patients who are being referred to medical interventions.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

The BREAST-Q REACT: Examining the Impact of Immediate Patient-reported Outcome Feedback and Interpretation in the Perioperative Period, a Feasibility Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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