Communicating Multiple Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
NCT ID: NCT07110597
Last Updated: 2025-09-16
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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COMPLETED
NA
3184 participants
INTERVENTIONAL
2025-07-18
2025-07-26
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 with equal allocation to 1 of 5 groups. The control group will receive information about a new cancer drug's benefits and harms; the intervention groups will also be given brief statements about sources of uncertainties with the drug's evidence (1, 2, 3, or 4 sources of uncertainties). The post-intervention questions will re-assess participants' decision making, perceptions of uncertainty, emotions, understanding, and trust.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Control group
No information about uncertainty given.
Control group
No information about uncertainty
1 source of uncertainty
Other: Statement communicating uncertainty with small magnitude of benefit
Statement communicating 1 source of uncertainty
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
2 sources of uncertainties
Other: Statements communicating uncertainty with a small magnitude of benefit and limited study population
Statements communicating 2 sources of uncertainties
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
3 sources of uncertainties
Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, and unvalidated surrogate endpoint
Statements communicating 3 sources of uncertainties
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
4 sources of uncertainties
Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, unvalidated surrogate endpoint, and limited study duration.
Statements communicating 4 sources of uncertainties
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
Interventions
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Statement communicating 1 source of uncertainty
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Statements communicating 2 sources of uncertainties
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
Statements communicating 3 sources of uncertainties
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
Statements communicating 4 sources of uncertainties
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
Control group
No information about uncertainty
Eligibility Criteria
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Inclusion Criteria
* Adults fluent in English
* Adults residing in the United States
* Participants who initiated the first survey about communicating individual sources of uncertainties (verified using unique participant identifiers assigned by the survey company)
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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London School of Economics and Political Science
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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This is the second of 2 studies on communicating uncertainties associated with the benefits and risks of new cancer drugs
Other Identifiers
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540788 (study 2)
Identifier Type: -
Identifier Source: org_study_id
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