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BMC Public Health. 2018 Feb 13;18(1):241. doi: 10.1186/s12889-018-5109-2.

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

Author information

1
The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, NH, USA. marie-anne.durand@dartmouth.edu.
2
The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, NH, USA.
3
Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.
4
Laura and Isaac Perlmutter Cancer Center, New York University School of Medicine, New York, NY, USA.
5
Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
6
Montefiore Medical Center, Bronx, NY, USA.
7
Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.
8
The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, and Norris Cotton Cancer Center, Lebanon, NH, USA.
9
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
10
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
11
University of Utah, Salt Lake City, UT, USA.
12
Massachusetts General Hospital's Chelsea HealthCare Center, Chelsea, MA, USA.

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.

KEYWORDS:

Breast cancer disparities; Breast cancer surgery; Decision support techniques; Encounter decision aids; Low socioeconomic status; Picture superiority

PMID:
29439691
PMCID:
PMC5812033
DOI:
10.1186/s12889-018-5109-2
[Indexed for MEDLINE]
Free PMC Article

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