Optimizing Surgical Decisions in Young Adults With Breast Cancer
Summary
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 approximately within 1 week of the surgical consult and approximately 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.
Detailed description
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.
Arms & interventions
- OtherCONSYDER decision aid
Web-based breast cancer surgery decision aid
Outcome measures
Primary
Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS)
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.
Time frame: pre-surgery
Use of CONSYDER pre-consult
Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult
Time frame: pre-surgery
Secondary
Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI)
Time frame: pre-surgery
Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
Time frame: pre-surgery
Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form
Time frame: pre-surgery and 6 months post-surgery
Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI).
Time frame: pre-surgery
Decisional regret as measured by the Decision Regret Scale (DRS)
Time frame: 6 months post-surgery
Receipt of contralateral prophylactic mastectomy
Time frame: 6 months post-surgery
Fidelity of implementation of CONSYDER via patient portal email
Time frame: pre-surgical consult
Use of CONSYDER post-consult
Time frame: up to 6 months post-surgical consult
Frequency of CONSYDER use pre-consult
Time frame: pre consult
Frequency of CONSYDER use post-consult
Time frame: up to 6 months post-surgical consult
Eligibility criteria
Study locations (4)
Yale Cancer Center
New Haven, Connecticut, 06510
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Weill Cornell Medicine
New York, New York, 10065
Duke Cancer Institute
Durham, North Carolina, 27710