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

• Published in: BMC public health 2018-02, Vol.18 (1), p.241-241, Article 241
• Main Authors: Durand, Marie-Anne, Yen, Renata West, O'Malley, A James, Politi, Mary C, Dhage, Shubhada, Rosenkranz, Kari, Weichman, Katie, Margenthaler, Julie, Tosteson, Anna N A, Crayton, Eloise, Jackson, Sherrill, Bradley, Ann, Volk, Robert J, Sepucha, Karen, Ozanne, Elissa, Percac-Lima, Sanja, Song, Julia, Acosta, Jocelyn, Mir, Nageen, Elwyn, Glyn
• Format: Article
• Language: English
• Subjects: Adult; Analysis; Breast cancer; Breast cancer disparities; Breast cancer surgery; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Cancer; Cancer surgery; Cancer therapies; Care and treatment; Clinical Protocols; Clinical trials; Communication; Community involvement; Community participation; Comparative analysis; Data analysis; Decision analysis; Decision Making; Decision Support Techniques; Decisions; Diagnosis; Emotions; Encounter decision aids; Female; Generalized linear models; Health aspects; Health care; Health education; Health literacy; Healthcare Disparities; Heterogeneity; Humans; Hypotheses; Knowledge; Low socioeconomic status; Lumpectomy; Malignancy; Mastectomy; Mediation; Minority & ethnic groups; Neoplasm Staging; Patient Satisfaction; Patients; Physician-Patient Relations; Picture superiority; Public health; Qualitative research; Quality of life; Randomization; Regression analysis; Risk Assessment; Social Class; Socioeconomic factors; Socioeconomics; Strata; Study Protocol; Surgery; Systematic review; Women's health; Womens health
• ISSN: 1471-2458; 1471-2458
• DOI: 10.1186/s12889-018-5109-2

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. 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. 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. NCT03136367 at ClinicalTrials.gov Protocol version: Manuscript based on study protocol version 2.2, 7 November 2017.