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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Avi Cherla
- Telefoonnummer: 020 7955 7975
- E-mail: avi_cherla@hphci.harvard.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Control
No uncertainty information
|
No uncertainty information
|
|
Actieve vergelijker: 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.
|
|
Actieve vergelijker: 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.
|
|
Actieve vergelijker: 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.
|
|
Actieve vergelijker: Multiple uncertainties
All 3 statements shown above
|
All 3 statements shown above
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hypothetical decisions
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Perceptions of treatment effectiveness
Tijdsspanne: 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
Tijdsspanne: Assessed immediately after the intervention
|
Please rate your agreement with the following statement
|
Assessed immediately after the intervention
|
|
Emotions
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Perceived importance in knowing about uncertainty
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 714377
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .