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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Annen: FDA explanation for progression-free survival (control)
- Annen: FDA explanation for progression-free survival with overall survival data
- Annen: NCI explanation for progression-free survival
- Annen: NCI explanation for progression-free survival with overall survival data
- Annen: Plain-language explanation of progression-free survival
- Annen: Plain-language explanation of progression-free survival with overall survival data
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Avi Cherla
- Telefonnummer: 020 7955 7975
- E-post: avi_cherla@hphci.harvard.edu
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Harvard Medical School and Harvard Pilgrim Health Care Institute
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Ta kontakt med:
- Avi Cherla
- Telefonnummer: 020 7852 3727
- E-post: avi_cherla@hphci.harvard.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: FDA explanation for progression-free survival (control)
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Progression-free survival
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Diagnose
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Resultatvurdering, helsehjelp
- Resultat og prosessvurdering, helsehjelp
- Statistikk som emne
- Prognose
- Behandlingsresultat
- Overlevelsesanalyse
- Progresjonsfri overlevelse
Andre studie-ID-numre
- 714377A
Plan for individuelle deltakerdata (IPD)
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