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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Ander: FDA explanation for progression-free survival (control)
- Ander: FDA explanation for progression-free survival with overall survival data
- Ander: NCI explanation for progression-free survival
- Ander: NCI explanation for progression-free survival with overall survival data
- Ander: Plain-language explanation of progression-free survival
- Ander: Plain-language explanation of progression-free survival with overall survival data
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Avi Cherla
- Telefoonnummer: 020 7955 7975
- E-mail: avi_cherla@hphci.harvard.edu
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Harvard Medical School and Harvard Pilgrim Health Care Institute
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Contact:
- Avi Cherla
- Telefoonnummer: 020 7852 3727
- 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)
- 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.
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: FDA explanation for progression-free survival (control)
|
Progression-free survival
|
|
Experimenteel: FDA explanation for progression-free survival with overall survival data
|
The description, 'progression-free survival', along with data on overall survival.
|
|
Experimenteel: NCI explanation for progression-free survival
|
The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
|
|
Experimenteel: NCI explanation for progression-free survival with overall survival data
|
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.
|
|
Experimenteel: Plain-language explanation of progression-free survival
|
The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
|
|
Experimenteel: Plain-language explanation of progression-free survival with overall survival data
|
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
Tijdsspanne: Assessed immediately after the intervention
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Perceptions of drug benefits and risks
Tijdsspanne: Assessed immediately after the intervention
|
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
|
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
- Neoplasmata
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Onderzoekstechnieken
- Epidemiologische methoden
- Diagnose
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Volksgezondheid
- Milieu en volksgezondheid
- Uitkomstbeoordeling, gezondheidszorg
- Uitkomst en procesbeoordeling, gezondheidszorg
- Statistieken als onderwerp
- Prognose
- Behandelingsresultaat
- Overlevingsanalyse
- Progressievrije overleving
Andere studie-ID-nummers
- 714377A
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
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