Breast Cancer MetastaticCOASTNCT07635147
Decision Support Tool for Patients With Advanced Breast Cancer
A study testing Decision Support Tool in people with Breast Cancer Metastatic and Advanced Breast Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer
- What is being tested?
- Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jun 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years and older
- Diagnosis of Stage IV breast cancer
- English, Spanish or Mandarin speaking
Who cannot join
- Early breast cancer
- Individuals speaking languages other than English, Spanish, or Mandarin as their primary language
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Zori K Hamilton, MA, 6469623694, zkh4001@med.cornell.edu
Evelyn Taiwo, MD
- Recruiting
NewYork-Presbyterian Medical Group Queens
Flushing, New York, 11355
Zori K Hamilton, MA, 646-962-3694, zkh4001@med.cornell.edu
Pooja Murthy, MD
- Recruiting
NewYork-Presbyterian David H. Koch Center
New York, New York, 10065
Zori K Hamilton, MA, 646-962-3694, zkh4001@med.cornell.edu
Shoshana Rosenberg, ScD, MPH
About this study
Official title: 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:
- Can the COAST tool improve the quality of communication between patients and their oncology providers?
- 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.
- Conditions
- Breast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer
- Being tested
- Decision Support Tool
- Keywords
- Decision support tool, advanced breast cancer, communication, Treatment preferences
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COAST intervention | Experimental | Not described Receives: Behavioral: Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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".
Measured: Baseline and follow-up (2-4 weeks after exposure to COAST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start17 Jun 2026
- Primary completionSep 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Shoshana Rosenberg, ScD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635147
- Sponsor's protocol ID
- 25-07029092
- Acronym
- COAST
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Options for Advanced Breast Cancer Support and Treatment (COAST)
- ClinicalTrials.gov ID
- NCT07635147
- Acronym / sponsor ID
- COAST / 25-07029092
- Conditions
- Breast Cancer Metastatic, Advanced Breast Cancer, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer
- Keywords
- Decision support tool, advanced breast cancer, communication, Treatment preferences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the COAST tool improve the quality of communication between patients and their oncology providers?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COAST intervention | Experimental | Behavioral: Decision Support Tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 years and older
- Diagnosis of Stage IV breast cancer
- English, Spanish or Mandarin speaking
Key exclusion criteria (2 listed)
- Early breast cancer
- Individuals speaking languages other than English, Spanish, or Mandarin as their primary language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Support ToolThe 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. | Behavioural | COAST intervention |
Primary outcome
Patient-reported acceptability of the COAST decision support tool
Time frame: 2-4 weeks after exposure to COAST
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%.
Patient-reported appropriateness of the COAST decision support tool
Time frame: 2-4 weeks after exposure to COAST
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%.
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.
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shoshana Rosenberg, ScD, MPH principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support Tool in people with Breast Cancer Metastatic and Advanced Breast Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zori K Hamilton, MA (646-962-3694, zkh4001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported acceptability of the COAST decision support tool (time frame: 2-4 weeks after exposure to COAST). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.