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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
3,000
Progression-free survival
The description, 'progression-free survival', along with data on overall survival.
The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States
Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
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
Time frame: Assessed immediately after the intervention
Perceptions of drug benefits and risks
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
Time frame: Assessed immediately after the intervention
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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.
The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.