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| Name | Class |
|---|---|
| Harvard Medical School / Harvard Pilgrim Health Care Institute | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm trial | Experimental |
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| Limited study duration (long-term benefits and harms) | Experimental |
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| Limited study population (generalizability) | Experimental |
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| Unvalidated surrogate endpoint | Experimental |
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| Treatment effect size (magnitude of benefit) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statement communicating uncertainty with a single arm trial | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in decisions | "Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely are you to take the new drug, Zenova?" 4-point Likert scale for decision: very likely; somewhat likely; somewhat unlikely; very unlikely. | 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention. |
| Understanding | Please answer rate your agreement with the following statements. Zenova works better than other treatments for non-small cell lung cancer Zenova's longer-term benefits and harms are well known 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 very large benefit for patients with non-small cell lung cancer 5-point Likert scale for understanding: strongly disagree; somewhat disagree; neither disagree or agree; somewhat agree; strongly agree. | 15-minute survey. Assessed post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in perception of uncertainty | "How certain are you that Zenova will work for Alex?" 4-point Likert scale for perception of uncertainty: very uncertain; somewhat uncertain; somewhat certain; very certain. | 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived importance of knowing about uncertainty | Was the additional information about Zenova helpful to your decision? 4-point Likert scale: strongly disagree; somewhat disagree; somewhat agree; strongly agree. Do you think that uncertainties about drug benefits and harms should always be communicated? 4-point Likert scale: strongly disagree; somewhat disagree; somewhat agree; strongly agree. Which of these uncertainties do you think are important to know when deciding about taking a new drug?
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avi Cherla | Contact | 16172011718 | a.j.cherla@lse.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Medical School and Harvard Pilgrim Health Care Institute | Recruiting | Boston | Massachusetts | 02139 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 8, 2025 |
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Double-blind
| Statement communicating uncertainty with limited study duration | Other | Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown. |
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| Statement communicating uncertainty with a limited study population | Other | 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. |
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| Statement communicating uncertainty with an unvalidated surrogate endpoint | Other | 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. |
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| Statement communicating uncertainty with treatment effect size | Other | It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. |
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| 15-minute survey. Assessed post-intervention. |
| May 20, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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