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

NCT06997185 | Recruiting

• 1 other identifier: 540788
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Uncertainty; Prescription drug information

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  15-minute survey. Assessed post-intervention.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Perceived importance of knowing about uncertainty

  15-minute survey. Assessed post-intervention.

Study Arms (5)

Single arm trial

EXPERIMENTAL

Other: Statement communicating uncertainty with a single arm trial

Limited study duration (long-term benefits and harms)

EXPERIMENTAL

Other: Statement communicating uncertainty with limited study duration

Limited study population (generalizability)

EXPERIMENTAL

Other: Statement communicating uncertainty with a limited study population

Unvalidated surrogate endpoint

EXPERIMENTAL

Other: Statement communicating uncertainty with an unvalidated surrogate endpoint

Treatment effect size (magnitude of benefit)

EXPERIMENTAL

Other: Statement communicating uncertainty with treatment effect size

Interventions

Statement communicating uncertainty with a single arm trial OTHER

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.

Single arm trial

Statement communicating uncertainty with limited study duration OTHER

Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.

Limited study duration (long-term benefits and harms)

Statement communicating uncertainty with a limited study population OTHER

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.

Limited study population (generalizability)

Statement communicating uncertainty with an unvalidated surrogate endpoint OTHER

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.

Unvalidated surrogate endpoint

Statement communicating uncertainty with treatment effect size OTHER

It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.

Treatment effect size (magnitude of benefit)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age and older
• Adults fluent in English
• Adults residing in the United States

Sponsors & Collaborators

• London School of Economics and Political Science: lead
• Harvard Medical School / Harvard Pilgrim Health Care Institute: collaborator

Study Sites (1)

Harvard Medical School and Harvard Pilgrim Health Care Institute

Boston, Massachusetts, 02139, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Avi Cherla

CONTACT

16172011718; a.j.cherla@lse.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 30, 2025
• Study Start: May 9, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)