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

London School of Economics and Political Science

Status: Completed

Conditions: Cancer

Treatments: Other: Statement communicating 1 source of uncertainty; Other: Statements communicating 2 sources of uncertainties; Other: Control group; Other: Statements communicating 3 sources of uncertainties; Other: Statements communicating 4 sources of uncertainties

Study type: Interventional

Funder types: Other

Identifiers

NCT07110597

540788 (study 2)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,184 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Participants who do not meet each of the 3 inclusion criteria
• Participants who initiated the first survey about communicating individual sources of uncertainties (verified using unique participant identifiers assigned by the survey company)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

3,184 participants in 5 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

No information about uncertainty given.

Treatment:

Other: Control group

1 source of uncertainty

Experimental group

Description:

Other: Statement communicating uncertainty with small magnitude of benefit

Treatment:

Other: Statement communicating 1 source of uncertainty

2 sources of uncertainties

Experimental group

Description:

Other: Statements communicating uncertainty with a small magnitude of benefit and limited study population

Treatment:

Other: Statements communicating 2 sources of uncertainties

3 sources of uncertainties

Experimental group

Description:

Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, and unvalidated surrogate endpoint

Treatment:

Other: Statements communicating 3 sources of uncertainties

4 sources of uncertainties

Experimental group

Description:

Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, unvalidated surrogate endpoint, and limited study duration.

Treatment:

Other: Statements communicating 4 sources of uncertainties