Optimizing Surgical Decisions in Young Adults With Breast Cancer
- Conditions
- Breast Cancer Stage IBreast Cancer Stage IIIBreast Cancer Stage 0Breast Cancer Stage II
- Interventions
- Other: CONSYDER decision aid
- Registration Number
- NCT06275126
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 800
- Female aged 18-44
- New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
- English or Spanish speaking
- Diagnosis of de novo Stage 4 breast cancer
- Recurrent early-stage breast cancer
- Bilateral breast cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CONSYDER decision aid CONSYDER decision aid Web-based breast cancer surgery decision aid
- Primary Outcome Measures
Name Time Method Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) pre-surgery 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.
Use of CONSYDER pre-consult pre-surgery Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult
- Secondary Outcome Measures
Name Time Method Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI) pre-surgery 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 as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) pre-surgery 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).
Frequency of CONSYDER use post-consult up to 6 months post-surgical consult Count of the number log-ins to CONSYDER post-consult
Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form pre-surgery and 6 months post-surgery 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.
Decisional regret as measured by the Decision Regret Scale (DRS) 6 months post-surgery 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.
Receipt of contralateral prophylactic mastectomy 6 months post-surgery Proportion of patients who undergo contralateral prophylactic mastectomy
Fidelity of implementation of CONSYDER via patient portal email pre-surgical consult Proportion of patients eligible to use CONSYDER who were sent an email from patient portal
Use of CONSYDER post-consult up to 6 months post-surgical consult Proportion of patients who logged in to CONSYDER post-surgical consult
Frequency of CONSYDER use pre-consult pre consult Count of the number log-ins to CONSYDER pre-consult
Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI). pre-surgery 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.
Trial Locations
- Locations (4)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States