CancerNCT07694310
Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences
A study testing Unvalidates surrogate endpoint, Limited study population and Small magnitude of effect in people with Cancer, run by London School of Economics and Political Science.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Unvalidates surrogate endpoint, Limited study population and Small magnitude of effect
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Control, Unvalidates surrogate endpoint, Limited study population, Small magnitude of effect, Multiple uncertainties
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
No uncertainty information
Unvalidates surrogate endpointOther
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.
Limited study populationOther
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.
Small magnitude of effectOther
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
Multiple uncertaintiesOther
All 3 statements shown above
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No uncertainty information Receives: Other: Control |
| Unvalidated surrogate endpoint | Active comparator | 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. Receives: Other: Unvalidates surrogate endpoint |
| Limited study population | Active comparator | 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. Receives: Other: Limited study population |
| Small magnitude of effect | Active comparator | It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. Receives: Other: Small magnitude of effect |
| Multiple uncertainties | Active comparator | All 3 statements shown above Receives: Other: Multiple uncertainties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed immediately after the intervention
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: Assessed immediately 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 posted9 Jul 2026
- Study start14 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School and Harvard Pilgrim Health Care Institute
- Responsible party
- Principal investigator, Avi Cherla, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694310
- Sponsor's protocol ID
- 714377
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07694310
- Acronym / sponsor ID
- 714377
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- Harvard Medical School and Harvard Pilgrim Health Care Institute
- Study start
- 14 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Jul 2026 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlNo uncertainty information |
| Unvalidated surrogate endpoint | Active comparator | Other: Unvalidates surrogate endpointZenova has only been shown to shrink the size of tumors. It is unknown whether Zenova improves how patients feel or how long they live. |
| Limited study population | Active comparator | Other: Limited study populationZenova 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. |
| Small magnitude of effect | Active comparator | Other: Small magnitude of effectIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. |
| Multiple uncertainties | Active comparator | Other: Multiple uncertaintiesAll 3 statements shown above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| ControlNo uncertainty information | Other | Control |
| Unvalidates surrogate endpointZenova 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 | Unvalidated surrogate endpoint |
| Limited study populationZenova 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 |
| Small magnitude of effectIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. | Other | Small magnitude of effect |
| Multiple uncertaintiesAll 3 statements shown above | Other | Multiple uncertainties |
Primary outcome
Hypothetical decisions
Time frame: 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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Unvalidates surrogate endpoint, Limited study population and Small magnitude of effect in people with Cancer, run by London School of Economics and Political Science.
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 4 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avi Cherla (020 7955 7975, avi_cherla@hphci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothetical decisions (time frame: Assessed immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.