Optimizing Surgical Decisions in Young Adults With Breast Cancer

Breast Cancer Stage II Clinical Trial

— CONSYDER  

Official title:

Optimizing Surgical Decisions in Young Adults With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275126
• Other study ID #: 23-08026433
• Secondary ID: R01CA256877-01A1
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: Shoshana Rosenberg, ScD, MPH
• Phone: 646-962-8041
• Email: shr4009[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: May 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Female aged 18-44

• New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer

• English or Spanish speaking

Exclusion Criteria:

• Diagnosis of de novo Stage 4 breast cancer

• Recurrent early-stage breast cancer

• Bilateral breast cancer

Related Conditions & MeSH terms

• Breast Cancer Stage 0
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Carcinoma In Situ
• Breast Neoplasms

Intervention

Other:
• CONSYDER decision aid
Web-based breast cancer surgery decision aid

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Duke Cancer Institute	Durham	North Carolina
United States	Yale Cancer Center	New Haven	Connecticut
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	pre-surgery
Primary	Use of CONSYDER pre-consult	Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult	pre-surgery
Secondary	Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI)	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.	pre-surgery
Secondary	Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)	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).	pre-surgery
Secondary	Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form	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.	pre-surgery and 6 months post-surgery
Secondary	Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI).	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.	pre-surgery
Secondary	Decisional regret as measured by the Decision Regret Scale (DRS)	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.	6 months post-surgery
Secondary	Receipt of contralateral prophylactic mastectomy	Proportion of patients who undergo contralateral prophylactic mastectomy	6 months post-surgery
Secondary	Fidelity of implementation of CONSYDER via patient portal email	Proportion of patients eligible to use CONSYDER who were sent an email from patient portal	pre-surgical consult
Secondary	Use of CONSYDER post-consult	Proportion of patients who logged in to CONSYDER post-surgical consult	up to 6 months post-surgical consult
Secondary	Frequency of CONSYDER use pre-consult	Count of the number log-ins to CONSYDER pre-consult	pre consult
Secondary	Frequency of CONSYDER use post-consult	Count of the number log-ins to CONSYDER post-consult	up to 6 months post-surgical consult