Cancer
Conditions
Keywords
cancer, prescription drugs, progression-free survival
Brief summary
This study of current or former cancer patients 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
Detailed description
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.
Interventions
OTHERFDA explanation for progression-free survival (control)
Progression-free survival
OTHERFDA explanation for progression-free survival with overall survival data
The description, 'progression-free survival', along with data on overall survival.
OTHERNCI 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'.
OTHERNCI 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.
OTHERPlain-language explanation of progression-free survival
The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
OTHERPlain-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.
Sponsors
London School of Economics and Political Science
Harvard Medical School and Harvard Pilgrim Health Care Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceptions of drug benefits and risks | 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 |
Countries
United States
Contacts
CONTACTAvi Cherla
Outcome results
None listed