Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences
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: Control, Unvalidates surrogate endpoint, Limited study population, Small magnitude of effect.
- 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
- Center list to be confirmed — check the primary protocol.
- 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 →
Official title
Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences: a Randomized Controlled Trial
Overview
This study of current or former cancer patients will evaluate the effect of learning about uncertainties with the benefits of a new cancer drug on their hypothetical decisions to take the drug and their perceptions of the drug's effectiveness.
Detailed description
Many new cancer drugs are approved based on uncertain benefits. Without knowledge of this information, patients may overestimate the benefits of new cancer drugs, resulting in decisions that are not reflective of their individual treatment preferences. A previous study found that learning about uncertainties with a new cancer drug's benefits (such as the drug's small magnitude of effect or limited trial population) reduced the proportion of people who were willing to take the drug. It is unclear whether these findings are generalizable to patients with cancer, who may have different treatment preferences, and may weigh uncertainty about the benefits of new cancer drugs differently from the general public.
In this study, US adults with a current or former cancer diagnosis will be recruited to evaluate the effect of learning about uncertainties with the benefits of a new cancer drug on their hypothetical decisions to take the drug and their perceptions of the drug's effectiveness. Patients will be randomized to 1 of 5 interventions: (1) no uncertainty information (control); or plain-language statements about uncertainties with (2) an unvalidated surrogate endpoint (unknown effect of the drug on survival or quality of life); (3) limited study population (the drug was not studied in patients of similar race or ethnicity); (4) small magnitude of effect (it is unknown whether patients would notice an improvement with the drug), or (5) a combination of all three uncertainties.
Interventions
- Other Control
No uncertainty information - Other Unvalidates 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 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 Small magnitude of effect
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. - Other Multiple uncertainties
All 3 statements shown above
Primary outcome measures
- Hypothetical decisions [Time frame: Assessed immediately after the intervention]
Secondary outcome measures (4)
- Perceptions of treatment effectiveness [Time frame: Assessed immediately after the intervention]
- Understanding [Time frame: Assessed immediately after the intervention]
- Emotions [Time frame: Assessed immediately after the intervention]
- Trust [Time frame: Assessed immediately after the intervention]
Eligibility criteria
Inclusion criteria
- US adults with a current or former cancer diagnosis (excluding nonmelanoma skin cancer),
- 18 years of age and older
- Fluent in English
- Residing in the United States.
Exclusion criteria
- Adults who do not have a former cancer diagnosis or who were diagnosed with nonmelanoma skin cancer
- Adults who complete the survey in under 150 seconds, and who do not meet the inclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07694310 · 714377