Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences
Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences: a Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Many new cancer drugs are approved based on uncertain benefits. Without knowledge of this information, patients may overestimate the benefits of new cancer drugs, resulting in decisions that are not reflective of their individual treatment preferences. A previous study found that learning about uncertainties with a new cancer drug's benefits (such as the drug's small magnitude of effect or limited trial population) reduced the proportion of people who were willing to take the drug. It is unclear whether these findings are generalizable to patients with cancer, who may have different treatment preferences, and may weigh uncertainty about the benefits of new cancer drugs differently from the general public.
In this study, US adults with a current or former cancer diagnosis will be recruited to evaluate the effect of learning about uncertainties with the benefits of a new cancer drug on their hypothetical decisions to take the drug and their perceptions of the drug's effectiveness. Patients will be randomized to 1 of 5 interventions: (1) no uncertainty information (control); or plain-language statements about uncertainties with (2) an unvalidated surrogate endpoint (unknown effect of the drug on survival or quality of life); (3) limited study population (the drug was not studied in patients of similar race or ethnicity); (4) small magnitude of effect (it is unknown whether patients would notice an improvement with the drug), or (5) a combination of all three uncertainties.
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
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),
- 18 years of age and older
- Fluent in English
- 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 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: Control
No uncertainty information
|
No uncertainty information
|
|
Comparateur actif: Unvalidated surrogate endpoint
Zenova has only been shown to shrink the size of tumors.
It is unknown whether Zenova improves how patients feel or how long they live.
|
Zenova has only been shown to shrink the size of tumors.
It is unknown whether Zenova improves how patients feel or how long they live.
|
|
Comparateur actif: Limited study population
Zenova has not been studied in patients similar to Alex (patients with her race and ethnicity).
It is unknown whether Zenova will work and what harms it will have for patients like her.
|
Zenova has not been studied in patients similar to Alex (patients with her race and ethnicity).
It is unknown whether Zenova will work and what harms it will have for patients like her.
|
|
Comparateur actif: Small magnitude of effect
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
|
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
|
|
Comparateur actif: Multiple uncertainties
All 3 statements shown above
|
All 3 statements shown above
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hypothetical decisions
Délai: Assessed immediately after the intervention
|
Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely would you be to take the new drug, Zenova?
|
Assessed immediately after the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceptions of treatment effectiveness
Délai: Assessed immediately after the intervention
|
Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely would you be to take the new drug, Zenova? - Response options: Very unlikely, somewhat unlikely, somewhat likely, very likely |
Assessed immediately after the intervention
|
|
Understanding
Délai: Assessed immediately after the intervention
|
Please rate your agreement with the following statement
|
Assessed immediately after the intervention
|
|
Emotions
Délai: Assessed immediately after the intervention
|
If you were Alex, how worried would you feel about taking Zenova? - Response options: Very worried, slightly worried, not very worried, not worried at all. |
Assessed immediately after the intervention
|
|
Trust
Délai: Assessed immediately after the intervention
|
To what extent do you think the information about Zenova is trustworthy? To what extent do you think the FDA, which approved Zenova and produced this information, is trustworthy? To what extent do you think Alex's doctor, who recommended and prescribed Zenova, is trustworthy? - Response options: Not at all trustworthy, somewhat untrustworthy, somewhat trustworthy, very trustworthy |
Assessed immediately after the intervention
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceived importance in knowing about uncertainty
Délai: Assessed immediately after the intervention
|
Please rate your agreement with the following: The information about Zenova was helpful. Uncertainties about drug benefits and harms should always be communicated. - Response options: Strongly disagree, somewhat disagree, somewhat agree, strongly agree. |
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
Autres numéros d'identification d'étude
- 714377
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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