Cancer
Conditions
Keywords
Cancer, Uncertainty, Prescription drug information
Brief summary
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
Detailed description
Many newer cancer drugs are approved before uncertainties with their underlying clinical trial evidence have been adequately studied, in turn making it difficult to accurately determine the drug's benefits and harms. Prescription drug information rarely communicates these uncertainties. In a nationally representative sample of US adults, this study will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding. In the pre-intervention phase, participants will be given information about a hypothetical new drug approved for the treatment of non-small cell lung cancer. Participants will be asked how likely they would be to take the drug, and how certain they are that the drug will work. Participants will then be randomized to 1 of 5 statements about a source of uncertainty with the drug's evidence that were based on the most common sources of uncertainties with new cancer drugs that are cited in FDA approval decisions: (1) single-arm trial designs, (2) limited study populations (i.e., generalizability of clinical trial evidence), and (3) limited study durations (i.e., long-term benefits and harms). Two additional uncertainties were also included that are frequently mentioned in the scientific literature: (4) the use of unvalidated surrogate endpoints to support new cancer drug approvals, and (5) uncertain treatment effect size (i.e., the magnitude of therapeutic benefit). The post-intervention questions will re-assess participants' decision making and perceptions of uncertainty, as well as their understanding of the uncertainty communicated in the statement.
Interventions
OTHERStatement communicating uncertainty with a single arm trial
Because Zenova has not been compared to other treatments, it is unknown if Zenova is better, the same, or worse than other treatments for non-small cell lung cancer.
OTHERStatement communicating uncertainty with limited study duration
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
OTHERStatement communicating uncertainty with a limited study population
Zenova has not been studied in patients similar to Alex (patients with her race and ethnicity). It is unknown whether Zenova will work and what harms it will have for patients like her.
OTHERStatement communicating uncertainty with an unvalidated surrogate endpoint
Zenova has only been shown to shrink the size of tumors. It is unknown whether Zenova improves how patients feel or how long they live.
OTHERStatement communicating uncertainty with treatment effect size
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Sponsors
Harvard Medical School / Harvard Pilgrim Health Care Institute
London School of Economics and Political Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 18 years of age and older * Adults fluent in English * Adults residing in the United States
Exclusion criteria
* Participants who do not meet each of the 3 inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in decisions | 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention. | Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely are you to take the new drug, Zenova? 4-point Likert scale for decision: very likely; somewhat likely; somewhat unlikely; very unlikely. |
| Understanding | 15-minute survey. Assessed post-intervention. | Please answer rate your agreement with the following statements. Zenova works better than other treatments for non-small cell lung cancer Zenova's longer-term benefits and harms are well known Zenova has been studied in patients that are similar to Alex (race and ethnicity) Zenova improves how patients feel or how long they live Zenova has a very large benefit for patients with non-small cell lung cancer 5-point Likert scale for understanding: strongly disagree; somewhat disagree; neither disagree or agree; somewhat agree; strongly agree. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in perception of uncertainty | 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention. | How certain are you that Zenova will work for Alex? 4-point Likert scale for perception of uncertainty: very uncertain; somewhat uncertain; somewhat certain; very certain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived importance of knowing about uncertainty | 15-minute survey. Assessed post-intervention. | Was the additional information about Zenova helpful to your decision? 4-point Likert scale: strongly disagree; somewhat disagree; somewhat agree; strongly agree. Do you think that uncertainties about drug benefits and harms should always be communicated? 4-point Likert scale: strongly disagree; somewhat disagree; somewhat agree; strongly agree. Which of these uncertainties do you think are important to know when deciding about taking a new drug? * Unknown whether the drug is better or worse than other treatments. * Unknown what the long-term benefits and harms of the drug are. * Unknown how well the drug will work for you (for example, someone of your age, of your race, or with your health conditions). * Unknown whether the drug will help you feel better or live longer. * Unknown whether the drug will make a noticeable difference (the benefits are too small to notice). 4-point Likert scale: not at all important; somewhat unimportant; somewhat important; very important. |
Countries
United States
Contacts
Primary ContactAvi Cherla
Outcome results
None listed