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Prior to institutional crossover, participants receive care as per usual care.

Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..

Usual Care

Web-based decision aid received prior to the surgical consultation

Web-based decision aid

Heather B. Neuman,, MD, MS

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.

II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.

SECONDARY OBJECTIVES:

I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.

Trial Design:

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.

ARM I: usual care

ARM II: decision aid intervention

The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.

Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.

Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by a third party and represents a count of patients' communicative behaviors ranging from 0-99, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).

Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.

This is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.

National Cancer Institute (NCI)

Agency for Healthcare Research and Quality (AHRQ)

Alliance for Clinical Trials in Oncology

Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.

Web-based breast cancer surgery decision aid

CONSYDER decision aid

Shoshana Rosenberg, ScD, MPH

Darima Dorzhieva

Rachel Greenup, MD, MPH

Ann Partridge, MD, MPH

Jennifer Plichta, MD, MS

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.

Participants will complete surveys within 1 week of the surgical consult and 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.

Primary objectives:

* To test the effectiveness of the CONSYDER decision support tool on reducing decisional conflict prior to breast cancer surgery.
* To evaluate the implementation of and mechanisms of use for CONSYDER.

Secondary Objectives:

* To determine the impact of CONSYDER on decision-making preferences, breast cancer knowledge, treatment goals and preferences, anxiety, decisional regret, and self-efficacy in communication.

Exploratory Objectives:

* To explore whether CONSYDER impacts surgical choice.

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network affiliate sites, over an approximate 30-month period. All sites will have a 6-month "run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be extended if recruitment targets are not met. Sites will be randomized to begin delivery of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part of routine clinical care; young women will have access to the website whether or not they consent to research study participation.

The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge design that will incorporate a mixed-methods approach to test the efficacy and evaluate the implementation of the CONSYDER intervention

Optimizing Surgical Decisions in Young Adults With Breast Cancer

De-identified data sets will made available, by request, to outside researchers. A data use agreement may be required with participating institutions to facilitate sharing of any data sets. Data from qualitative interviews, focus groups, audio-recordings, and any data collected from clinicians/providers will not be made available due to concerns about potentially identifying information being shared.

The Decisional Conflict Scale (DCS) includes 5 subscales (uncertainty, informed, values clarity, support, effective decision). Each item is rated on a scale of 0 (strongly agree)-4 (strongly disagree). Scores range from 0-100 with higher scores indicating more decisional conflict.

Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult

Breast cancer knowledge will be assessed using selected questions from the adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions. The number of correct responses across (out of a total of 5 items) will be summed.

Treatment goals and preferences have been adapted from the BCS-DQI to include preferences salient to young women. We will ask participants to mark on a scale (not important, 0-extremely important, 10) the importance of several reasons in relation to their surgical decision. Ratings for each item will be summarized (e.g., mean, median, range).

Anxiety, as measured with the 8-item PROMIS - Anxiety - Short Form. Response options for each item range from never (1) to always (5). Raw scores range from 5-40 and T-scores range from 37.1-83.1. Higher scores indicate higher levels of anxiety.

Perceived Efficacy in Patient-Physician Interactions scale (PEPPI) has 5 items. Each item is rated on a (0, not confident at all - 10, extremely confident) scale. Scores range from 0-50, with higher scores indicating greater self-efficacy.

The Decision Regret Scale (DRS) includes 5 items. Each item is rated on a scale of 1 (strongly agree)-5 (strongly disagree). Scores range from 0-100 (item scores are converted by subtracting "1" from individual items and multiplying by 25). Higher scores indicate more decisional regret.

Proportion of patients who undergo contralateral prophylactic mastectomy

Proportion of patients eligible to use CONSYDER who were sent an email from patient portal

Proportion of patients who logged in to CONSYDER post-surgical consult

Count of the number log-ins to CONSYDER pre-consult

Count of the number log-ins to CONSYDER post-consult

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making	NCT03766009	Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S...	Usual Care Web-based decis...	18 Years -	Alliance for Clinical Trials in Oncology
Optimizing Surgical Decisions in Young Adults With Breast Cancer	NCT06275126	Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S...	CONSYDER decisi...	18 Years - 44 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for breast cancer stage 0