CancerNCT07110597
Communicating Multiple Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
A study testing Statement communicating 1 source of uncertainty, Statements communicating 2 sources of uncertainties and Statements communicating 3 sources of uncertainties in people with Cancer, run by London School of Economics and Political Science at 1 site in United Kingdom.
Trial summary
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Statement communicating 1 source of uncertainty, Statements communicating 2 sources of uncertainties and Statements communicating 3 sources of uncertainties
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,184 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2025to 26 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years of age and older
- Adults fluent in English
- Adults residing in the United States
Who cannot join
- Participants who do not meet each of the 3 inclusion criteria
- Participants who initiated the first survey about communicating individual sources of uncertainties (verified using unique participant identifiers assigned by the survey company)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Economics and Political Science
London
About this study
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.
Read the 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 multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.
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 with equal allocation to 1 of 5 groups. The control group will receive information about a new cancer drug's benefits and harms; the intervention groups will also be given brief statements about sources of uncertainties with the drug's evidence (1, 2, 3, or 4 sources of uncertainties). The post-intervention questions will re-assess participants' decision making, perceptions of uncertainty, emotions, understanding, and trust.
- Conditions
- Cancer
- Being tested
- Statement communicating 1 source of uncertainty, Statements communicating 2 sources of uncertainties, Statements communicating 3 sources of uncertainties, Statements communicating 4 sources of uncertainties, Control group
- Keywords
- Uncertainty, Prescription drug information
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statement communicating 1 source of uncertaintyOther
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Statements communicating 2 sources of uncertaintiesOther
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
Statements communicating 3 sources of uncertaintiesOther
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
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.
Statements communicating 4 sources of uncertaintiesOther
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
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.
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.
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
Control groupOther
No information about uncertainty
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | No information about uncertainty given. Receives: Other: Control group |
| 1 source of uncertainty | Experimental | Other: Statement communicating uncertainty with small magnitude of benefit Receives: Other: Statement communicating 1 source of uncertainty |
| 2 sources of uncertainties | Experimental | Other: Statements communicating uncertainty with a small magnitude of benefit and limited study population Receives: Other: Statements communicating 2 sources of uncertainties |
| 3 sources of uncertainties | Experimental | Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, and unvalidated surrogate endpoint Receives: Other: Statements communicating 3 sources of uncertainties |
| 4 sources of uncertainties | Experimental | Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, unvalidated surrogate endpoint, and limited study duration. Receives: Other: Statements communicating 4 sources of uncertainties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-making: very likely; somewhat likely; somewhat unlikely; very unlikely
Measured: Immediately prior to and after the intervention.
Secondary outcomes (4)
Change in 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
4-point Likert scale for understanding: strongly disagree; somewhat disagree; somewhat agree; strongly agree.
Measured: Immediately prior to and after the intervention.
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.
Measured: Immediately prior to and after the intervention.
Change in emotions
If you were Alex, how worried would you feel about taking Zenova?
4-point Likert scale for worry: extremely worried; slightly worried; not very worried; not worried at all.
Measured: Immediately prior to and after the intervention.
Trust
To what extent do you think the information about Zenova is trustworthy? 4-point Likert scale: not at all trustworthy; somewhat untrustworthy; somewhat trustworthy; very trustworthy.
To what extent do you think the FDA, who approved Zenova and produced this information, is trustworthy? 4-point Likert scale: not at all trustworthy; somewhat untrustworthy; somewhat trustworthy; very trustworthy.
Did learning about these uncertainties with Zenova make you more or less trusting of the FDA? 4-point Likert scale: less trusting, somewhat less trusting, somewhat more trusting, more trusting.
Measured: Immediately prior to and after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start18 Jul 2025
- Primary completion26 Jul 2025
- Study completion26 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School / Harvard Pilgrim Health Care Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110597
- Sponsor's protocol ID
- 540788 (study 2)
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cherla A, Wagner AK, Woloshin S, Davis C, Bourgeois FT, Mossialos E, Naci H. Communicating Uncertainties About the Benefits and Risks of New Cancer Drugs: Two Randomized Clinical Trials. JAMA Intern Med. 2026 Oct 12. doi: 10.1001/jamainternmed.2026.4969. Online ahead of print.
PubMed 42862585
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Multiple Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
- ClinicalTrials.gov ID
- NCT07110597
- Acronym / sponsor ID
- 540788 (study 2)
- Conditions
- Cancer
- Keywords
- Uncertainty, Prescription drug information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,184 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- Harvard Medical School / Harvard Pilgrim Health Care Institute
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 26 Jul 2025 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.
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 multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.
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 with equal allocation to 1 of 5 groups. The control group will receive information about a new cancer drug's benefits and harms; the intervention groups will also be given brief statements about sources of uncertainties with the drug's evidence (1, 2, 3, or 4 sources of uncertainties). The post-intervention questions will re-assess participants' decision making, perceptions of uncertainty, emotions, understanding, and trust.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Control groupNo information about uncertainty given. |
| 1 source of uncertainty | Experimental | Other: Statement communicating 1 source of uncertaintyOther: Statement communicating uncertainty with small magnitude of benefit |
| 2 sources of uncertainties | Experimental | Other: Statements communicating 2 sources of uncertaintiesOther: Statements communicating uncertainty with a small magnitude of benefit and limited study population |
| 3 sources of uncertainties | Experimental | Other: Statements communicating 3 sources of uncertaintiesOther: Statements communicating uncertainty with a small magnitude of benefit, limited study population, and unvalidated surrogate endpoint |
| 4 sources of uncertainties | Experimental | Other: Statements communicating 4 sources of uncertaintiesOther: Statements communicating uncertainty with a small magnitude of benefit, limited study population, unvalidated surrogate endpoint, and limited study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age and older
- Adults fluent in English
- Adults residing in the United States
Key exclusion criteria (2 listed)
- Participants who do not meet each of the 3 inclusion criteria
- Participants who initiated the first survey about communicating individual sources of uncertainties (verified using unique participant identifiers assigned by the survey company)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statement communicating 1 source of uncertaintyIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. | Other | 1 source of uncertainty |
| Statements communicating 2 sources of uncertaintiesIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. 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 | 2 sources of uncertainties |
| Statements communicating 3 sources of uncertaintiesIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. 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. 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 | 3 sources of uncertainties |
| Statements communicating 4 sources of uncertaintiesIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. 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. 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. Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown. | Other | 4 sources of uncertainties |
| Control groupNo information about uncertainty | Other | Control group |
Primary outcome
Change in decisions
Time frame: Immediately prior to and after the intervention.
"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-making: very likely; somewhat likely; somewhat unlikely; very unlikely
4 secondary outcomes
Change in understanding
Time frame: Immediately prior to and after the intervention.
Change in perception of uncertainty
Time frame: Immediately prior to and after the intervention.
Change in emotions
Time frame: Immediately prior to and after the intervention.
Trust
Time frame: Immediately prior to and after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 42862585Cherla A, Wagner AK, Woloshin S, Davis C, Bourgeois FT, Mossialos E, Naci H. Communicating Uncertainties About the Benefits and Risks of New Cancer Drugs: Two Randomized Clinical Trials. JAMA Intern Med. 2026 Oct 12. doi: 10.1001/jamainternmed.2026.4969. Online ahead of print.
- This is the second of 2 studies on communicating uncertainties associated with the benefits and risks of new cancer drugsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statement communicating 1 source of uncertainty, Statements communicating 2 sources of uncertainties and Statements communicating 3 sources of uncertainties in people with Cancer, run by London School of Economics and Political Science at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decisions (time frame: Immediately prior to and after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07110597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.