Decision Support Tool for Patients With Advanced Breast Cancer (COAST)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Darima Dorzhieva
- Telefoonnummer: 646-962-8666
- E-mail: dad4011@med.cornell.edu
Studie Contact Back-up
- Naam: Zori K Hamilton, MA
- Telefoonnummer: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
Studie Locaties
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New York
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Brooklyn, New York, Verenigde Staten, 11215
- Werving
- NewYork-Presbyterian Brooklyn Methodist Hospital
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Hoofdonderzoeker:
- Evelyn Taiwo, MD
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Contact:
- Zori K Hamilton, MA
- Telefoonnummer: 6469623694
- E-mail: zkh4001@med.cornell.edu
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Flushing, New York, Verenigde Staten, 11355
- Werving
- NewYork-Presbyterian Medical Group Queens
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Contact:
- Zori K Hamilton, MA
- Telefoonnummer: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
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Hoofdonderzoeker:
- Pooja Murthy, MD
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New York, New York, Verenigde Staten, 10065
- Werving
- NewYork-Presbyterian David H. Koch Center
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Hoofdonderzoeker:
- Shoshana Rosenberg, ScD, MPH
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Contact:
- Zori K Hamilton, MA
- Telefoonnummer: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: COAST intervention
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient-reported acceptability of the COAST decision support tool
Tijdsspanne: 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%. |
2-4 weeks after exposure to COAST
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Patient-reported appropriateness of the COAST decision support tool
Tijdsspanne: 2-4 weeks after exposure to COAST
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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%. |
2-4 weeks after exposure to COAST
|
|
Provider-reported feasibility of the COAST decision support tool
Tijdsspanne: 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. |
At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Baseline Decisional Conflict Scale Score
Tijdsspanne: Baseline and follow-up (2-4 weeks after exposure to COAST)
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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.
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Baseline and follow-up (2-4 weeks after exposure to COAST)
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Change in patient-centered communication
Tijdsspanne: 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.
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Baseline and follow-up (2-4 weeks after exposure to COAST)
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Change in decisional self-efficacy score
Tijdsspanne: Baseline and follow-up (2-4 weeks after exposure to COAST)
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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".
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Baseline and follow-up (2-4 weeks after exposure to COAST)
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Shoshana Rosenberg, ScD, MPH, Weill Medical College of Cornell University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25-07029092
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