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BMC Public Health
Published in: BMC Public Health 1/2018

Open Access 01-12-2018 | Study protocol

What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata

Authors: Marie-Anne Durand, Renata West Yen, A. James O’Malley, Mary C. Politi, Shubhada Dhage, Kari Rosenkranz, Katie Weichman, Julie Margenthaler, Anna N. A. Tosteson, Eloise Crayton, Sherrill Jackson, Ann Bradley, Robert J. Volk, Karen Sepucha, Elissa Ozanne, Sanja Percac-Lima, Julia Song, Jocelyn Acosta, Nageen Mir, Glyn Elwyn

Published in: BMC Public Health | Issue 1/2018

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Abstract

Background

Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata.

Methods

We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions’ sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed.

Discussion

Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially leading to poorer decision quality, quality of life, and decision regret. This study hopes to identify solutions that effectively improve patient-centered care across socioeconomic strata and reduce disparities in decision and care quality.

Trial registration

NCT03136367 at ClinicalTrials.gov
Protocol version: Manuscript based on study protocol version 2.2, 7 November 2017.
Appendix
Available only for authorised users
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Metadata
Title
What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata
Authors
Marie-Anne Durand
Renata West Yen
A. James O’Malley
Mary C. Politi
Shubhada Dhage
Kari Rosenkranz
Katie Weichman
Julie Margenthaler
Anna N. A. Tosteson
Eloise Crayton
Sherrill Jackson
Ann Bradley
Robert J. Volk
Karen Sepucha
Elissa Ozanne
Sanja Percac-Lima
Julia Song
Jocelyn Acosta
Nageen Mir
Glyn Elwyn
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2018
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-018-5109-2

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