Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Statement communicating uncertainty with a single arm trial, Statement communicating uncertainty with limited study duration, Statement communicating uncertainty with a limited study population, Statement communicating uncertainty with an unvalidated surrogate endpoint.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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 different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
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 to 1 of 5 statements about a source of uncertainty with the drug's evidence that were based on the most common sources of uncertainties with new cancer drugs that are cited in FDA approval decisions: (1) single-arm trial designs, (2) limited study populations (i.e., generalizability of clinical trial evidence), and (3) limited study durations (i.e., long-term benefits and harms). Two additional uncertainties were also included that are frequently mentioned in the scientific literature: (4) the use of unvalidated surrogate endpoints to support new cancer drug approvals, and (5) uncertain treatment effect size (i.e., the magnitude of therapeutic benefit). The post-intervention questions will re-assess participants' decision making and perceptions of uncertainty, as well as their understanding of the uncertainty communicated in the statement.
Interventions
- Other Statement communicating uncertainty with a single arm trial
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. - Other Statement communicating uncertainty with limited study duration
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown. - Other Statement communicating uncertainty with a limited study population
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. - Other Statement communicating uncertainty with an unvalidated surrogate endpoint
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. - Other Statement communicating uncertainty with treatment effect size
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Primary outcome measures
- Change in decisions [Time frame: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.]
- Understanding [Time frame: 15-minute survey. Assessed post-intervention.]
Secondary outcome measures (1)
- Change in perception of uncertainty [Time frame: 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Harvard Medical School and Harvard Pilgrim Health Care Institute — Boston
Identifiers
NCT: NCT06997185 · 540788