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Recruiting NCT07635147

Decision Support Tool for Patients With Advanced Breast Cancer

No phase Interventional Breast Cancer Metastatic Advanced Breast Cancer Stage 4 Breast Cancer Stage IV (Metastatic) Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision Support Tool.
Who it may be relevant to
Registry conditions: Breast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Patient-reported acceptability of the COAST decision support tool [Time frame: 2-4 weeks after exposure to COAST]
  • Patient-reported appropriateness of the COAST decision support tool [Time frame: 2-4 weeks after exposure to COAST]
  • Provider-reported feasibility of the COAST decision support tool [Time frame: At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.]
Secondary outcome measures (3)
  • Change in Baseline Decisional Conflict Scale Score [Time frame: Baseline and follow-up (2-4 weeks after exposure to COAST)]
  • Change in patient-centered communication [Time frame: Baseline and follow-up (2-4 weeks after exposure to COAST)]
  • Change in decisional self-efficacy score [Time frame: Baseline and follow-up (2-4 weeks after exposure to COAST)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn
  • NewYork-Presbyterian David H. Koch Center — New York
  • NewYork-Presbyterian Medical Group Queens — New York

Identifiers

NCT: NCT07635147 · 25-07029092

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗