What Matters Most: Choosing the Right Breast Cancer Surgery for You

Background and Significance

Breast cancer is the most commonly diagnosed malignancy in women. Despite improvements in
survival, women of low socioeconomic status (SES) diagnosed with early stage breast cancer:

- Continue to experience poorer doctor-patient communication, lower satisfaction with
surgery and decision making, and higher decision regret compared to women of higher SES;

- Often play a passive role in decision making;

- Are less likely to undergo breast-conserving surgery (BCS);

- Are less likely to receive optimal care.

Those differences are disparities that predominantly affect women of low SES with early stage
breast cancer, irrespective of race or ethnicity. For early stage breast cancer, low SES is a
stronger predictor of poorer outcomes, treatment received and death, than race or ethnicity.
The investigators define low SES as a lower income, lower educational attainment, and
uninsured or state-insured status

Although BCS is the recommended treatment for early stage breast cancer (stages I to IIIA),
research confirms equivalent survival between mastectomy and BCS. Both options are offered
yet have distinct harms and benefits, valued differently by patients. The patient and
stakeholder partners involved in this study have emphasized the critical importance of
supporting women in making high quality breast cancer surgery decisions (good knowledge and
alignment between the patient's choice, values and priorities) irrespective of SES and health
literacy. Yet, research shows that women of low SES are not usually involved in an informed,
patient-centered dialogue about surgery choice. There is no evidence that women of low SES
have distinct preferences that explain a lower uptake of BCS and limited engagement in
decision making. Further, communication strategies are not typically adapted to women of low
SES and low health literacy. Most decision aids for breast cancer have been designed for
highly literate audiences, with poor accessibility and readability. Simpler, shorter decision
aids delivered in the clinical encounter (encounter decision aids) may be more beneficial to
underserved patients, and could reduce disparities. It is critical to determine how to
effectively support women of low SES in making informed breast cancer surgery choices.

Study Aims

First, the investigators will assess the comparative effectiveness of two effective encounter
decision aids (Option Grid and Picture Option Grid) against usual care on decision quality
(primary outcome), shared decision making, treatment choice and other secondary outcomes
across socioeconomic strata (Aim 1). Second, the investigators aim to explore the effect of
the Picture Option Grid on disparities in decision making (decision quality, knowledge, and
shared decision making), treatment choice, as well as mediation and moderation effects (Aim
2). Third, in order to maximize the implementation potential, the investigators will explore
strategies that promote the encounter decision aids' sustained use and dissemination using a
theoretical implementation model (Aim 3).

Study Description

The investigators will conduct a three-arm, multi-site randomized controlled superiority
trial with stratification by SES (Aims 1 and 2) and randomization at the clinician level. One
thousand, one hundred patients (half of higher SES and half of lower SES) will be recruited
from five large cancer centers. In preparation for the trial (Year 01), the investigators
will conduct semi-structured interviews with women of low SES who have completed treatment
for early stage breast cancer to adapt the "What Matters Most to You" subscale of the
Decision Quality Instrument (DQI) for women of low SES. Lastly, the investigators will use
interviews, field-notes, and observations to explore strategies that promote the
interventions' sustained use and dissemination using the Normalization Process Theory (Aim
3). Community-Based Participatory Research will be used throughout the trial (with continuous
patient and stakeholder involvement).

Women 18 years and older with a confirmed diagnosis of early stage breast cancer (I to IIIA)
from both higher and lower SES will be included in the trial, provided they have a basic
command of English, Spanish, or Mandarin. About 367 patients will be recruited per arm.

Both interventions have been developed, tested, and shown to be effective. The Option Grid
(intervention 1) is a one-page evidence-based summary of available options presented in a
tabular format, listing the trade-offs that patients normally consider when making breast
cancer surgery decisions. The Picture Option Grid (intervention 2) uses the same evidence and
tabular layout, but it is tailored to women of lower SES and low health literacy and includes
simple text and images. Because decision aids are not routinely available in real world
settings, usual care is a coherent and legitimate comparator. It will include the provision
of usual information resources about breast cancer but will exclude the provision of other
decision aids.

Secondary outcome measures will include treatment choice, the validated 3-item CollaboRATE
measure of shared decision-making (SDM), Chew's validated one-item health literacy screening
question, PROMIS, an 8-item validated anxiety short form, EQ-5D-5L, a validated, standardized
6-item quality of life measure, and four items from COST, a validated financial toxicity
measure. Participants will also be asked to estimate their out-of-pocket expenses over the
past month. All measures will be available in English, Spanish, and Mandarin. Observer
OPTION5 will be used to rate the level of shared decision making in the clinical encounter.

A regression framework (logistic regression, linear regression, mixed effect regression
models, generalized estimating equations) and mediation analyses will be used in the
analysis. The investigators will also use multiple informants analysis to measure and examine
SES and multiple imputation to manage missing data. Heterogeneity of treatment effects
analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed.
The investigators will also use the recordings of surgical consultations to analyze the
conversations about costs and treatment recommendations made by providers.

Inclusion Criteria:

- Assigned female at birth;

- 18 years and older;

- Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);

- Eligible for both breast-conserving surgery and mastectomy based on medical records
and clinician's opinion before surgery;

- Spoken English, Spanish, or Mandarin Chinese.

Exclusion Criteria:

- Transgender men and women;

- Women who have undergone prophylactic mastectomy;

- Women with visual impairment;

- Women with a diagnosis of severe mental illness or severe dementia;

- Women with inflammatory breast carcinoma.