NCT07635147

Brief Summary

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jun 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Feb 2028

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Breast Cancer MetastaticAdvanced Breast CancerStage 4 Breast CancerStage IV (Metastatic) Breast Cancer

Keywords

Decision support tooladvanced breast cancercommunicationTreatment preferences

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Change in Baseline Decisional Conflict Scale Score

    Baseline and follow-up (2-4 weeks after exposure to COAST)

  • Change in patient-centered communication

    Baseline and follow-up (2-4 weeks after exposure to COAST)

  • Change in decisional self-efficacy score

    Baseline and follow-up (2-4 weeks after exposure to COAST)

Study Arms (1)

COAST intervention

EXPERIMENTAL
Behavioral: Decision Support Tool

Interventions

Decision Support ToolBEHAVIORAL

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.

COAST intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

NewYork-Presbyterian David H. Koch Center

New York, New York, 10065, United States

Location

NewYork-Presbyterian Medical Group Queens

New York, New York, 11355, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisCommunication

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Shoshana Rosenberg, ScD, MPH

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zori K Hamilton, MA

CONTACT

646-962-3694zkh4001@med.cornell.edu

Darima Dorzhieva

CONTACT

646-962-8666dad4011@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)