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

NCT ID: NCT07110597

Last Updated: 2025-09-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-18

Study Completion Date

2025-07-26

Brief Summary

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This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.

Detailed Description

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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 multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.

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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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

No information about uncertainty given.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

No information about uncertainty

1 source of uncertainty

Other: Statement communicating uncertainty with small magnitude of benefit

Group Type EXPERIMENTAL

Statement communicating 1 source of uncertainty

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Statements communicating 2 sources of uncertainties

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Statements communicating 3 sources of uncertainties

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Statements communicating 4 sources of uncertainties

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Control group

No information about uncertainty

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years of age and older
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard Medical School / Harvard Pilgrim Health Care Institute

UNKNOWN

Sponsor Role collaborator

London School of Economics and Political Science

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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London School of Economics and Political Science

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://www.clinicaltrials.gov/study/NCT06997185?term=communicating%20risk&viewType=Table&rank=8

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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