Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
NCT ID: NCT06997185
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2025-05-09
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Single arm trial
Statement 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.
Limited study duration (long-term benefits and harms)
Statement 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.
Limited study population (generalizability)
Statement 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.
Unvalidated surrogate endpoint
Statement 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.
Treatment effect size (magnitude of benefit)
Statement communicating uncertainty with treatment effect size
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Interventions
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Statement 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.
Statement 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.
Statement 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.
Statement 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.
Statement communicating uncertainty with treatment effect size
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Eligibility Criteria
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Inclusion Criteria
* Adults fluent in English
* Adults residing in the United States
18 Years
ALL
Yes
Sponsors
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Harvard Medical School / Harvard Pilgrim Health Care Institute
UNKNOWN
London School of Economics and Political Science
OTHER
Responsible Party
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Locations
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Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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540788
Identifier Type: -
Identifier Source: org_study_id
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