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
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Andet: FDA explanation for progression-free survival (control)
- Andet: FDA explanation for progression-free survival with overall survival data
- Andet: NCI explanation for progression-free survival
- Andet: NCI explanation for progression-free survival with overall survival data
- Andet: Plain-language explanation of progression-free survival
- Andet: Plain-language explanation of progression-free survival with overall survival data
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Avi Cherla
- Telefonnummer: 020 7955 7975
- E-mail: avi_cherla@hphci.harvard.edu
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Harvard Medical School and Harvard Pilgrim Health Care Institute
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Kontakt:
- Avi Cherla
- Telefonnummer: 020 7852 3727
- E-mail: avi_cherla@hphci.harvard.edu
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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)
- 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.
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: FDA explanation for progression-free survival (control)
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Progression-free survival
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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: Plain-language explanation of progression-free survival with overall survival data
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The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceptions of drug benefits and risks
Tidsramme: Assessed immediately after the intervention
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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
|
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
- Neoplasmer
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Diagnose
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Resultatvurdering, sundhedsvæsen
- Resultat og procesvurdering, sundhedsvæsen
- Statistik som emne
- Prognose
- Behandlingsresultat
- Overlevelsesanalyse
- Progressionfri overlevelse
Andre undersøgelses-id-numre
- 714377A
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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