Decision Support Tool / Advanced Breast Cancer / Stage 4 Breast Cancer · Interventional Study

Decision Support Tool for Patients With Advanced Breast Cancer

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective, single-arm pilot study currently recruiting patients with advanced breast cancer to evaluate the acceptability, appropriateness, and feasibility of COAST, a decision support tool designed to improve shared decision-making. No results are yet available in this registry record; the study is still enrolling participants.

What was studied

Interventional, Single Group, Open label, Supportive Care purpose. Breast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer; age from 18 Years. Intervention: COAST intervention. n = 100. 3 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active, uncontrolled pilot feasibility study evaluating acceptability and provider feasibility of a decision support tool in advanced breast cancer; no results are posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Patient-reported acceptability of the COAST decision support tool (assessed at 2-4 weeks after exposure to COAST); Patient-reported appropriateness of the COAST decision support tool (assessed at 2-4 weeks after exposure to COAST); Provider-reported feasibility of the COAST decision support tool (assessed at At the conclusion of participant enrollment, approximately 1 month after the la…)

DesignInterventional, Single Group, Open label, Supportive Care purpose

PopulationBreast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer; age from 18 Years

Sample size100

InterventionCOAST intervention

Setting3 sites: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment100

Primary outcome measure 1Patient-reported acceptability of COAST, 2–4 weeks after exposure

Primary outcome measure 2Patient-reported appropriateness of COAST, 2–4 weeks after exposure

Primary outcome measure 3Provider-reported feasibility of COAST, at conclusion of enrollment (~1 month after last patient enrolled)

Caveats

No results are reported in this registry record; the study is currently recruiting.
Single-arm design with no control group; cannot establish efficacy or superiority.
Primary outcomes are patient and provider-reported acceptability and feasibility, not clinical outcomes (e.g., quality of life, treatment adherence, survival).
Interview data mentioned in brief summary but not specified as a formal outcome measure.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm pilot study with no control group; measures acceptability and feasibility only.

Directness

moderate

Directly measures patient and provider experience with the intervention in relevant clinical setting.

Consistency

insufficient

No results reported; consistency cannot be assessed against prior work.

Risk of bias

limited

No blinding; single-arm design; no control comparator limits causal inference.

Sample adequacy

limited

Estimated 100 participants; appropriate for pilot feasibility, underpowered for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07635147). This is a study registration, not published results. Lead sponsor: Weill Medical College of Cornell University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Breast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer. Interventions: BEHAVIORAL: Decision Support Tool. Primary outcome measures: Patient-reported acceptability of the COAST decision support tool , 2-4 weeks after exposure to COAST; Patient-reported appropriateness of the COAST decision support tool , 2-4 weeks after exposure to COAST; Provider-reported feasibility of the COAST decision support tool , At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.. 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Decision Support ToolAdvanced Breast CancerStage 4 Breast CancerBreast Cancer MetastaticWeill Medical College of Cornell UniversityNCT07635147