Advanced Breast Cancer, Breast Cancer Metastatic, Stage 4 Breast Cancer, Stage IV (Metastatic) Breast Cancer
Conditions
Keywords
Decision support tool, advanced breast cancer, communication, Treatment preferences
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.
Interventions
BEHAVIORALDecision 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.
Sponsors
Weill Medical College of Cornell University
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported acceptability of the COAST decision support tool | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Decisional Conflict Scale Score | Baseline and follow-up (2-4 weeks after exposure to COAST) | 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. |
| Change in patient-centered communication | Baseline and follow-up (2-4 weeks after exposure to COAST) | 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. |
| Change in decisional self-efficacy score | Baseline and follow-up (2-4 weeks after exposure to COAST) | 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". |
Countries
United States
Contacts
CONTACTZori K Hamilton, MA
CONTACTDarima Dorzhieva
PRINCIPAL_INVESTIGATORShoshana Rosenberg, ScD, MPH
Weill Medical College of Cornell University
Outcome results
None listed