Clinical trial NCT03136367: What Matters Most: Choosing the Right Breast Cancer Surgery for You
Official title: Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: encounter decision aids
shared decision making
socioeconomic status
disparities
decision quality
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Montefiore Medical Center
name: NYU Langone Health
name: Patient-Centered Outcomes Research Institute
First posted: 2017-05-02
Enrollment: 571
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm randomized controlled superiority trial with stratification by SES and randomization at the clinician level. Patient enrollment will occur at five cancer centers in the United States. Patients will be enrolled in one of the three arms based on the clinician they are seeing as a part of their care.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments. What Matters Most will be comparing two decision aids used in the clinic visit to usual care (what normally happens in the clinic). The first decision aid (Option Grid) presents evidence-based information about lumpectomy and mastectomy in a tabular format using text only. The second decision aid (Picture Option Grid) presents evidence-based information about lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most aims to show that the interventions can reduce disparities in decision-making and treatment choice between women of high and low SES.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Decision Quality: Knowledge Subscale
timeFrame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery
measure: Change in Decision Quality: Decison Process Subscale
timeFrame: Immediately after the index surgical consultation visit and at one week post-surgery
measure: Change in Decision Quality: Concordance Subscale
timeFrame: Immediately after the index surgical consultation visit and at one week post-surgery
Secondary outcomes:
measure: Number of Participants Who Chose Lumpectomy or Mastectomy as Their Treatment Choice
timeFrame: 1 week post-surgery
measure: Change in Quality of Life
timeFrame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
measure: Anxiety
timeFrame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit, at 1 week post-surgery, and at 12 weeks post-surgery
measure: Shared Decision-making (Self-reported)
timeFrame: Immediately after the index surgical consultation visit
measure: Shared Decision-making (Observed)
timeFrame: During the index surgical consultation visit
measure: Decision Regret
timeFrame: At 1 week post-surgery, 12 weeks post-surgery, and 1 year post-surgery
measure: Integration of Health Care Delivery
timeFrame: Immediately before the index surgical consultation visit and at 12 weeks post-surgery
measure: Exploration of Strategies That Promote the Interventions' Sustained Use and Dissemination
timeFrame: 12 weeks post-surgery (patients) or after trial participation ended (surgeons)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Marie-Ann Durand, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
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