Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About Medicines

NCT07061197 | Not Yet Recruiting

• 1 other identifier: 494342
• Study Type: interventional
• Target: 2,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This online randomized controlled trial will evaluate whether adding a key information section to patient information leaflets leads to more accurate expectations and improves participants' understanding. We will test the impact of including quantitative information on drug benefits in addition to qualitative statements, versus including qualitative statements only. Participants will be randomly assigned to one of three groups: (1) a standard patient leaflet that contains no information on drug benefits, (2) a leaflet featuring a key information section that includes qualitative statements about drug benefits, or (3) a leaflet featuring a key information section that includes quantitative information about drug benefits in addition to qualitative statements.

Conditions

Cancer

Keywords

Cancer; Prescription drug information

Outcome Measures

Primary Outcomes (1)

• Expectations

  Multiple choice questions assessing expectations about the benefits of tivozanib, a cancer drug approved by the European Medicines Agency. For example, "does Fotivda cure advanced kidney cancer?" Measured on a 4 point-Likert scale: definitely yes; probably yes; probably no; definitely no.. See attached protocol.

  Assessed during 15-minute survey.

Secondary Outcomes (3)

• Understanding

  Assessed during 15-minute survey.

• Perceived magnitude of benefits and harms

  Assessed during 15-minute survey

• Satisfaction with information in the patient leaflet

  Assessed during 15-minute survey.

Study Arms (3)

Control (standard patient leaflet)

PLACEBO COMPARATOR

Other: Control (standard patient leaflet)

Patient leaflet with the EMA's proposed key information section including qualitative statements

EXPERIMENTAL

Other: Patient leaflet with the EMA's proposed key information section including qualitative statements.

Patient leaflet with a key information section providing qualitative and quantitative information

EXPERIMENTAL

Other: Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.

Interventions

Patient leaflet with the EMA's proposed key information section including qualitative statements. OTHER

The standard patient leaflet supplemented with a key information section. This section included qualitative descriptions of the goal of treatment, the main benefits, contraindications, and the most serious side effects. The content was designed to reflect the EMA's proposed format for improving the patient information leaflet.

Patient leaflet with the EMA's proposed key information section including qualitative statements

Control (standard patient leaflet) OTHER

The standard patient information leaflet for a recently approved cancer drug, tivozanib (Fotivda), obtained electronically from the EMA website. The standard patient information does not contain structured benefit information.

Control (standard patient leaflet)

Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms. OTHER

The standard patient leaflet, supplemented with a key information section including quantitative data on the drug's main benefits and side effects, presented in a summary table format. This section provided structured information about the indication and goal of treatment, how the drug was studied (the comparator treatment and number of patients enrolled in the clinical trial that supported the drug's approval), and data on the drug's benefits and side effects.

Patient leaflet with a key information section providing qualitative and quantitative information

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 Kingdom (i.e., nationally representative sample of UK adults).

Sponsors & Collaborators

• London School of Economics and Political Science: lead
• King's College London: collaborator

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share