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Development and Psychometric Validation of the BREAST-Q Sensation Module for Women Undergoing Post-Mastectomy Breast Reconstruction

  • Reconstructive Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Reconstructive techniques for restoring sensation to the breast after mastectomy continue to evolve. The BREAST-Q is a patient-reported outcome measure that can be used to evaluate outcomes of breast cancer treatments; however, it previously lacked scales to measure breast sensation. This paper outlines the development and validation of the BREAST-Q Sensation Module.

Methods

Phase 1 (January 2017 through December 2018) involved qualitative and cognitive interviews with women who had undergone breast reconstruction, as well as expert input, to develop and refine the scales. In phase 2 (March through June 2019), Love Research Army (LRA) members completed the scales, and Rasch Measurement Theory (RMT) analysis was performed to examine the reliability and validity of the scales.

Results

In this study, 36 qualitative and 7 cognitive interviews were conducted, and input from 18 experts was obtained. Three scales were developed to measure breast Symptoms (e.g., throbbing, burning, tingling), Sensation (e.g., feeling with light touch, through clothing, sexually), and Quality of Life impact of sensation loss. In phase 2, 1204 LRA members completed the scales. Data for each scale fit the RMT model. Reliability was high, with Person Separation Index, Cronbach alpha, and intraclass correlation coefficient values of 0.81 or higher (with and without extremes) for all three scales. Mean scores were higher (better) on the Symptoms and Quality of Life impact scales for the participants with unilateral (vs. bilateral) and autologous (vs. alloplastic) reconstruction, and for the participants who were farther out from their reconstruction.

Conclusion

The BREAST-Q Sensation Module can be used alone or in conjunction with other BREAST-Q scales to inform clinical care and to evaluate outcomes of new surgical approaches to restoration of breast sensation.

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Acknowledgment

Phases 1 and 2 of this study were supported by the Canadian Breast Cancer Foundation Project Grant (now integrated into Canadian Cancer Society) (Grant No. 319371). Phase 2 of this study was supported by the Plastic Surgery Foundation.

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Authors and Affiliations

  1. Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, USA

    Elena Tsangaris PhD, Justin Broyles MD & Andrea L. Pusic MD, MSc

  2. McMaster University, Hamilton, ON, Canada

    Anne F. Klassen DPhil, Manraj N. Kaur PT, PhD & Sophocles Voineskos MD, MSc

  3. Juravinski Cancer Center, Hamilton, ON, Canada

    Louise Bordeleau MD, MSc

  4. Toronto General Hospital, Toronto, ON, Canada

    Toni Zhong MD, MHS

Authors
  1. Elena Tsangaris PhD
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  2. Anne F. Klassen DPhil
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  5. Louise Bordeleau MD, MSc
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  8. Andrea L. Pusic MD, MSc
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Corresponding author

Correspondence to Elena Tsangaris PhD.

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Disclosure

The BREAST-Q Sensation Module is owned by Memorial Sloan-Kettering Cancer Center, McMaster University, and Mass General Brigham, and Drs Pusic and Klassen are co-developers. The remaining authors have no conflicts of interest. Drs Anne Klassen, Toni Zhong, and Manraj Kaur are grateful for funding from the Canadian Institutes of Health Research (CIHR). Dr. Kaur holds a CIHR Training Award. The funders were not involved in the design of the study, data collection or analysis, decision to publish, or preparation of the manuscript.

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Tsangaris, E., Klassen, A.F., Kaur, M.N. et al. Development and Psychometric Validation of the BREAST-Q Sensation Module for Women Undergoing Post-Mastectomy Breast Reconstruction. Ann Surg Oncol 28, 7842–7853 (2021). https://doi.org/10.1245/s10434-021-10094-y

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