Decision Support Tool for Patients With Advanced Breast Cancer (COAST)

Communicating Options for Advanced Breast Cancer Support and Treatment (COAST)

The goal of this pilot study is to understand and improve the shared decision-making process between people with advanced breast cancer and their providers regarding their care and treatment. As part of this study, the researchers will evaluate a decision support tool called COAST that was designed to support patients and providers in having meaningful conversations. The main questions it aims to answer are:

1. Can the COAST tool improve the quality of communication between patients and their oncology providers?
2. Is the COAST tool acceptable, appropriate, and easy to use at NYP-Weill Cornell Medicine, NYP-Brooklyn Methodist Hospital and NYP-Queens?

Participants will be asked to fill out two surveys: one before they use the COAST tool and another about 2 - 4 weeks later. Some patients will also be invited for an interview.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Breast Cancer; Breast Cancer Metastatic; Stage 4 Breast Cancer; Stage IV (Metastatic) Breast Cancer
• Intervention / Treatment: Behavioral: Decision Support Tool

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darima Dorzhieva; Phone Number: 646-962-8666; Email: dad4011@med.cornell.edu
• Study Contact Backup: Name: Zori K Hamilton, MA; Phone Number: 646-962-3694; Email: zkh4001@med.cornell.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • NewYork-Presbyterian Brooklyn Methodist Hospital
      • Contact: Zori K Hamilton, MA; Phone Number: 646-962-3694; Email: zkh4001@med.cornell.edu
      • Principal Investigator: Evelyn Taiwo, MD
    • New York, New York, United States, 10065
      • NewYork-Presbyterian David H. Koch Center
      • Principal Investigator: Shoshana Rosenberg, ScD, MPH
      • Contact: Zori K Hamilton, MA; Phone Number: 646-962-3694; Email: zkh4001@med.cornell.edu
    • New York, New York, United States, 11355
      • NewYork-Presbyterian Medical Group Queens
      • Contact: Zori K Hamilton, MA; Phone Number: 646-962-3694; Email: zkh4001@med.cornell.edu
      • Principal Investigator: Pooja Murthy, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female 18 years and older
• Diagnosis of Stage IV breast cancer
• English, Spanish or Mandarin speaking

Exclusion Criteria:

• Early breast cancer
• Individuals speaking languages other than English, Spanish, or Mandarin as their primary language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COAST intervention	Behavioral: Decision Support Tool; The COAST decision support tool will be available in two formats: a booklet and a website. It will provide information about advanced breast cancer and the available treatment options. Participants will be guided through questions designed to clarify their goals and preferences, identify support needs, and concerns they may have.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported acceptability of the COAST decision support tool	The proportion of patients who agree with the acceptability of the COAST decision support tool is measured by the Acceptability of Intervention Measure (AIM). This tool consists of four items designed to monitor and evaluate the success of implementation efforts. Respondents can rate each item on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores reflect greater agreement with the acceptability of the intervention. Patients with a score of 4 or higher will be included in the numerator, while all patients who complete the measure will be included in the denominator. We will define COAST as "acceptable" if this proportion is greater than 70%.	2-4 weeks after exposure to COAST
Patient-reported appropriateness of the COAST decision support tool	The proportion of patients who agree with the appropriateness of the COAST decision support tool is measured using the Intervention Appropriateness Measure (IAM). This tool consists of four items designed to evaluate the suitability and relevance of an intervention. Respondents can rate each item on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores reflect greater agreement with the appropriateness of the intervention. Patients with a score of 4 or higher will be included in the numerator, while all patients who complete the measure will be included in the denominator. We will define COAST as "appropriate" if this proportion is greater than 70%.	2-4 weeks after exposure to COAST
Provider-reported feasibility of the COAST decision support tool	The proportion of healthcare providers who care for adult patients with metastatic breast cancer (MBC) and agree on the feasibility of the COAST decision support tool is measured using the Feasibility of Intervention Measure (FIM). This tool consists of four items designed to measure the feasibility or extent to which an intervention can be successfully used or carried out within a given setting. Respondents can rate each item on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores reflect greater agreement with the feasibility of implementing the COAST tool. Providers with a score of 4 or higher will be included in the numerator, while all providers who complete the measure will be included in the denominator. We will define COAST as "feasible" if this proportion is 70% or greater.	At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baseline Decisional Conflict Scale Score	Mean change from baseline in patient decisional conflict will be assessed via Decisional Conflict Scale (DCS), which includes 5 subscales (uncertainty, informed, values clarity, support, effective decision). Each item is rated on a scale of 0 (strongly agree) to 4 (strongly disagree). Scores range from 0-100 with higher scores indicating more decisional conflict.	Baseline and follow-up (2-4 weeks after exposure to COAST)
Change in patient-centered communication	Mean change from baseline in patient-centered communication score will be assessed via Patient-Centered Communication (PCC) in cancer care. The purpose of the measure is to assess PCC in six core domains: 1) exchanging information, 2) making decisions, 3) fostering healing relationships, 4) enabling patient self-management, 5) managing uncertainty, and 6) responding to emotions. Respondents can rate each item on a scale, where higher scores indicate better patient-centered communication and greater perceived support from the healthcare team.	Baseline and follow-up (2-4 weeks after exposure to COAST)
Change in decisional self-efficacy score	Mean Change from Baseline in patient self-efficacy for making decisions will be assessed via the Decisional Self-Efficacy Scale. The Scale measures self-confidence or belief in one's abilities in decision making, including shared decision-making. Respondents can rate each item on a scale from 0 (not at all confident) to 4 (very confident). A score of 0 means "extremely low self-efficacy" and a score of 100 means "extremely high self-efficacy".	Baseline and follow-up (2-4 weeks after exposure to COAST)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Shoshana Rosenberg, ScD, MPH, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: communication; advanced breast cancer; Decision support tool; Treatment preferences
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Breast Neoplasms; Neoplasm Metastasis; Communication
• Other Study ID Numbers: 25-07029092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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