Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT06997185
• Lead Sponsor: London School of Economics and Political Science

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.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-09
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Harvard Medical School and Harvard Pilgrim Health Care Institute; 🇺🇸 Boston, Massachusetts, United States