Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences

Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Control; Other: Unvalidates surrogate endpoint; Other: Limited study population; Other: Small magnitude of effect; Other: Multiple uncertainties

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Avi Cherla; Phone Number: 020 7955 7975; Email: avi_cherla@hphci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; No uncertainty information	Other: Control; No uncertainty information
Active Comparator: 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: 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.
Active Comparator: 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: 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.
Active Comparator: Small magnitude of effect; It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.	Other: Small magnitude of effect; It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Active Comparator: Multiple uncertainties; All 3 statements shown above	Other: Multiple uncertainties; All 3 statements shown above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothetical decisions	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	Assessed immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptions of treatment effectiveness	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	Assessed immediately after the intervention
Understanding	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	Assessed immediately after the intervention
Emotions	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.	Assessed immediately after the intervention
Trust	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	Assessed immediately after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived importance in knowing about uncertainty	Please rate your agreement with the following: The information about Zenova was helpful. Uncertainties about drug benefits and harms should always be communicated. - Response options: Strongly disagree, somewhat disagree, somewhat agree, strongly agree.	Assessed immediately after the intervention

Collaborators and Investigators

• Sponsor: London School of Economics and Political Science
• Collaborators: Harvard Medical School and Harvard Pilgrim Health Care Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 14, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 714377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No