Decision Support Tool for Patients With Advanced Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18 years and older

Diagnosis of Stage IV breast cancer

English, Spanish or Mandarin speaking

Disqualifiers

Early breast cancer

Individuals speaking languages other than English, Spanish, or Mandarin as their primary language

Trial design

Design model

Single group

Treatments tested in this trial

  • Decision Support Tool

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: COAST interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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.

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

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