Optimizing Surgical Decisions in Young Adults With Breast Cancer (CONSYDER)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer Stage 0
• Intervention / Treatment: Other: CONSYDER decision aid

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.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shoshana Rosenberg, ScD, MPH; Phone Number: 646-962-8041; Email: shr4009@med.cornell.edu
• Study Contact Backup: Name: Darima Dorzhieva; Phone Number: 646-962-8666; Email: dad4011@med.cornell.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale Cancer Center
      • Contact: Rachel Greenup, MD, MPH; Phone Number: 203-737-2966; Email: rachel.greenup@yale.edu
      • Principal Investigator: Rachel Greenup, MD, MPH
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Ann Partridge, MD, MPH
      • Contact: Ann Partridge, MD, MPH; Phone Number: 617-632-3800; Email: ann_partridge@dfci.harvard.edu
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Shoshana Rosenberg, ScD, MPH; Phone Number: 646-962-8041; Email: shr4009@med.cornell.edu
      • Contact: Darima Dorzhieva; Phone Number: 646-962-8666; Email: dad4011@med.cornell.edu
      • Principal Investigator: Shoshana Rosenberg, ScD, MPH
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Institute
      • Contact: Jennifer Plichta, MD, MS; Phone Number: 919-681-9156; Email: jennifer.plichta@duke.edu
      • Principal Investigator: Jennifer Plichta, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER.
Other: CONSYDER decision aid; Web-based breast cancer surgery decision aid	Other: CONSYDER decision aid; Web-based breast cancer surgery decision aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Use of CONSYDER pre-consult	Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult	pre-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Receipt of contralateral prophylactic mastectomy	Proportion of patients who undergo contralateral prophylactic mastectomy	6 months post-surgery
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
Use of CONSYDER post-consult	Proportion of patients who logged in to CONSYDER post-surgical consult	up to 6 months post-surgical consult
Frequency of CONSYDER use pre-consult	Count of the number log-ins to CONSYDER pre-consult	pre consult
Frequency of CONSYDER use post-consult	Count of the number log-ins to CONSYDER post-consult	up to 6 months post-surgical consult

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Shoshana Rosenberg, ScD, MPH, Weill Medical College of Cornell University; Principal Investigator: Rachel Greenup, MD, MPH, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ
• Other Study ID Numbers: 23-08026433; R01CA256877-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available following publication of the primary endpoints of the study. No end date.
• IPD Sharing Access Criteria: Requests must be made in writing to the principal investigators. A data use agreement may be required with participating institutions to facilitate sharing of any data sets.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No