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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Avi Cherla
- Telefonnummer: 020 7955 7975
- E-mail: avi_cherla@hphci.harvard.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Control
No uncertainty information
|
No uncertainty information
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: Multiple uncertainties
All 3 statements shown above
|
All 3 statements shown above
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hypothetical decisions
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceptions of treatment effectiveness
Tidsramme: 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
Tidsramme: Assessed immediately after the intervention
|
Please rate your agreement with the following statement
|
Assessed immediately after the intervention
|
|
Emotions
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived importance in knowing about uncertainty
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 714377
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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