Cancer
Conditions
Brief summary
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
OTHERControl
No uncertainty information
OTHERUnvalidates 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.
OTHERLimited 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.
OTHERSmall magnitude of effect
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
OTHERMultiple uncertainties
All 3 statements shown above
Sponsors
London School of Economics and Political Science
Harvard Medical School and Harvard Pilgrim Health Care Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypothetical decisions | Assessed immediately after the intervention | Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely would you be to take the new drug, Zenova? * Response options: Very unlikely, somewhat unlikely, somewhat likely, very likely |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceptions of treatment effectiveness | Assessed immediately after the intervention | Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely would you be to take the new drug, Zenova? \- Response options: Very unlikely, somewhat unlikely, somewhat likely, very likely |
| Understanding | Assessed immediately after the intervention | Please rate your agreement with the following statement * 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 noticeable improvement for patients * Response options: Strongly disagree, somewhat disagree, somewhat agree, strongly agree |
| Emotions | Assessed immediately after the intervention | If you were Alex, how worried would you feel about taking Zenova? \- Response options: Very worried, slightly worried, not very worried, not worried at all. |
| Trust | Assessed immediately after the intervention | To what extent do you think the information about Zenova is trustworthy? To what extent do you think the FDA, which approved Zenova and produced this information, is trustworthy? To what extent do you think Alex's doctor, who recommended and prescribed Zenova, is trustworthy? \- Response options: Not at all trustworthy, somewhat untrustworthy, somewhat trustworthy, very trustworthy |
Contacts
CONTACTAvi Cherla
Outcome results
None listed