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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Darima Dorzhieva
- Numéro de téléphone: 646-962-8666
- E-mail: dad4011@med.cornell.edu
Sauvegarde des contacts de l'étude
- Nom: Zori K Hamilton, MA
- Numéro de téléphone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
Lieux d'étude
-
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New York
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Brooklyn, New York, États-Unis, 11215
- Recrutement
- NewYork-Presbyterian Brooklyn Methodist Hospital
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Chercheur principal:
- Evelyn Taiwo, MD
-
Contact:
- Zori K Hamilton, MA
- Numéro de téléphone: 6469623694
- E-mail: zkh4001@med.cornell.edu
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Flushing, New York, États-Unis, 11355
- Recrutement
- NewYork-Presbyterian Medical Group Queens
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Contact:
- Zori K Hamilton, MA
- Numéro de téléphone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
-
Chercheur principal:
- Pooja Murthy, MD
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New York, New York, États-Unis, 10065
- Recrutement
- NewYork-Presbyterian David H. Koch Center
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Chercheur principal:
- Shoshana Rosenberg, ScD, MPH
-
Contact:
- Zori K Hamilton, MA
- Numéro de téléphone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-reported acceptability of the COAST decision support tool
Délai: 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
|
|
Patient-reported appropriateness of the COAST decision support tool
Délai: 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%. |
2-4 weeks after exposure to COAST
|
|
Provider-reported feasibility of the COAST decision support tool
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Baseline Decisional Conflict Scale Score
Délai: 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.
|
Baseline and follow-up (2-4 weeks after exposure to COAST)
|
|
Change in patient-centered communication
Délai: 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.
|
Baseline and follow-up (2-4 weeks after exposure to COAST)
|
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Change in decisional self-efficacy score
Délai: 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".
|
Baseline and follow-up (2-4 weeks after exposure to COAST)
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Shoshana Rosenberg, ScD, MPH, Weill Medical College of Cornell University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25-07029092
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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