An interventional study of Decision Support Tool in Breast Cancer Metastatic, Advanced Breast Cancer and Stage 4 Breast Cancer, sponsored by Weill Medical College of Cornell University. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Supportive care
Among 31 studies in Breast Neoplasms by Weill Medical College of Cornell University — 11 open to participants now, 15 under way, 2 of them phase 3. Breast Neoplasms · Weill Medical College of Cornell University.
Among the 31 studies in Breast Neoplasms by Weill Medical College of Cornell University, this one is the 9th largest by planned enrollment of the 27 interventional ones, is one of 3 that started in 2026, is one of 10 with no phase, reaches primary completion later than 6 of the 14 other live ones, and was the 31st registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →11 of the 31 studies in Breast Neoplasms by Weill Medical College of Cornell University are open now, in 1 country. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 3 started in 2026.
Median enrollment 74 across the 27 interventional studies, 200 across the 3 observational. Of the 15 that completed or were terminated, 7 (47%) have results posted.
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
5 of the studies in Breast Neoplasms by Weill Medical College of Cornell University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03804944Weill Medical College of Cornell UniversityConverting HR+ Breast Cancer Into an Individualized Vaccine | 2026-12-31 |
| NCT07300995Weill Medical College of Cornell UniversityBehavioral Pain Intervention for Older Cancer Patients | 2027-04-30 |
| NCT06275126Weill Medical College of Cornell UniversityOptimizing Surgical Decisions in Young Adults With Breast Cancer | 2027-05-01 |
| NCT07635147Weill Medical College of Cornell UniversityDecision Support Tool for Patients With Advanced Breast Cancer | 2027-09 |
| NCT04563507Weill Medical College of Cornell UniversityCombined Immunotherapies in Metastatic ER+ Breast Cancer | 2027-10-31 |
Among the 31 studies in Breast Neoplasms by Weill Medical College of Cornell University, from their registry updates:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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%.
Time frame: 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%.
Time frame: 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.
Time frame: At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.
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.
Time frame: 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.
Time frame: 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".
Time frame: Baseline and follow-up (2-4 weeks after exposure to COAST)
Plan to share: No
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