An interventional study of Statement communicating uncertainty with a single arm trial and Statement communicating uncertainty with limited study duration in Cancer, sponsored by London School of Economics and Political Science. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by London School of Economics and Political Science · Not applicable, Interventional, and Other
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.
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →London School of Economics and Political Science is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Other: Statement communicating uncertainty with a single arm trial
Other: Statement communicating uncertainty with limited study duration
Other: Statement communicating uncertainty with a limited study population
Other: Statement communicating uncertainty with an unvalidated surrogate endpoint
Other: Statement communicating uncertainty with treatment effect size
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.
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
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.
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.
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Change in decisions
"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.
Time frame: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.
Understanding
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.
Time frame: 15-minute survey. Assessed post-intervention.
Change in perception of uncertainty
"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.
Time frame: 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention.
Perceived importance of knowing about uncertainty
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.
Time frame: 15-minute survey. Assessed post-intervention.
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London School of Economics and Political Science