Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival
Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Autre: FDA explanation for progression-free survival (control)
- Autre: FDA explanation for progression-free survival with overall survival data
- Autre: NCI explanation for progression-free survival
- Autre: NCI explanation for progression-free survival with overall survival data
- Autre: Plain-language explanation of progression-free survival
- Autre: Plain-language explanation of progression-free survival with overall survival data
Description détaillée
Progression-free survival (PFS) (the time until a tumour grows, spreads, or the patient dies) is among the most common outcomes supporting the approval of new cancer drugs. Likely owing to similar terminology and the use of the word 'survival', patients often confuse PFS with overall survival, which may lead to treatment decisions that are not aligned with patients' individual preferences. Alternative descriptions of PFS that acknowledge the absence of a survival benefit may improve understanding.
This randomized controlled trial will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs, since patients may only understand the distinction between these outcomes when they are presented with data on both. Three alternative descriptions for PFS will be compared, including those used by the FDA, the National Cancer Institute, and a plain-language version that was developed drawing on prior work about communicating PFS. This study will also compare the additive effect of overall survival data for each alternative description of PFS.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Avi Cherla
- Numéro de téléphone: 020 7955 7975
- E-mail: avi_cherla@hphci.harvard.edu
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Harvard Medical School and Harvard Pilgrim Health Care Institute
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Contact:
- Avi Cherla
- Numéro de téléphone: 020 7852 3727
- E-mail: avi_cherla@hphci.harvard.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- US adults with a current or former cancer diagnosis (excluding nonmelanoma skin cancer)
- US adults 18 years of age and older, fluent in English, and residing in the United States.
Exclusion Criteria:
- Adults who do not have a former cancer diagnosis or who were diagnosed with nonmelanoma skin cancer; adults who complete the survey in under 150 seconds, and who do not meet the other inclusion criteria.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: FDA explanation for progression-free survival (control)
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Progression-free survival
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Expérimental: FDA explanation for progression-free survival with overall survival data
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The description, 'progression-free survival', along with data on overall survival.
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Expérimental: NCI explanation for progression-free survival
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The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
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Expérimental: NCI explanation for progression-free survival with overall survival data
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The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse', along with data on overall survival.
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Expérimental: Plain-language explanation of progression-free survival
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The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
|
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Expérimental: Plain-language explanation of progression-free survival with overall survival data
|
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
Délai: Assessed immediately after the intervention
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Compared to standard treatment, do patients with advanced kidney cancer live longer when treated with Velotrex? - Response options: definitely yes, probably yes, probably no, definitely no |
Assessed immediately after the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceptions of drug benefits and risks
Délai: Assessed immediately after the intervention
|
How would you describe the benefits of Velotrex? - Very large, large, moderate, small, very small to none Do you think the benefits of Velotrex outweigh the side effects? - Response options: definitely yes, probably yes, probably no, definitely no Which treatment would you recommend to a patient with kidney cancer - Response options: Velotrex, standard treatment |
Assessed immediately after the intervention
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
- Tumeurs
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Diagnostic
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Évaluation des résultats, soins de santé
- Évaluation des résultats et des processus, soins de santé
- Statistiques comme sujet
- Pronostic
- Résultat du traitement
- Analyse de Survie
- Survie sans progression
Autres numéros d'identification d'étude
- 714377A
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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