CancerNCT07731425
Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival
A study testing FDA explanation for progression-free survival with overall survival data, NCI explanation for progression-free survival and NCI explanation for progression-free survival with overall survival data in people with Cancer, run by London School of Economics and Political Science at 1 site in United States.
Trial summary
This study of current or former cancer patients will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- FDA explanation for progression-free survival with overall survival data, NCI explanation for progression-free survival and NCI explanation for progression-free survival with overall survival data
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 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)
- US adults 18 years of age and older, fluent in English, and 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 other inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02215
Avi Cherla, 020 7852 3727, avi_cherla@hphci.harvard.edu
About this study
Official title: Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial
This study of current or former cancer patients will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs
Read the detailed description
Progression-free survival (PFS) (the time until a tumour grows, spreads, or the patient dies) is among the most common outcomes supporting the approval of new cancer drugs. Likely owing to similar terminology and the use of the word 'survival', patients often confuse PFS with overall survival, which may lead to treatment decisions that are not aligned with patients' individual preferences. Alternative descriptions of PFS that acknowledge the absence of a survival benefit may improve understanding.
This randomized controlled trial will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs, since patients may only understand the distinction between these outcomes when they are presented with data on both. Three alternative descriptions for PFS will be compared, including those used by the FDA, the National Cancer Institute, and a plain-language version that was developed drawing on prior work about communicating PFS. This study will also compare the additive effect of overall survival data for each alternative description of PFS.
- Conditions
- Cancer
- Being tested
- FDA explanation for progression-free survival (control), FDA explanation for progression-free survival with overall survival data, NCI explanation for progression-free survival, NCI explanation for progression-free survival with overall survival data, Plain-language explanation of progression-free survival
- Keywords
- cancer, prescription drugs, progression-free survival
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDA explanation for progression-free survival (control)Other
Progression-free survival
FDA explanation for progression-free survival with overall survival dataOther
The description, 'progression-free survival', along with data on overall survival.
NCI explanation for progression-free survivalOther
The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
NCI explanation for progression-free survival with overall survival dataOther
The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse', along with data on overall survival.
Plain-language explanation of progression-free survivalOther
The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
Plain-language explanation of progression-free survival with overall survival dataOther
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.
| Study group | Role | What they receive |
|---|---|---|
| FDA explanation for progression-free survival (control) | Placebo comparator | Not described Receives: Other: FDA explanation for progression-free survival (control) |
| FDA explanation for progression-free survival with overall survival data | Experimental | Not described Receives: Other: FDA explanation for progression-free survival with overall survival data |
| NCI explanation for progression-free survival | Experimental | Not described Receives: Other: NCI explanation for progression-free survival |
| NCI explanation for progression-free survival with overall survival data | Experimental | Not described Receives: Other: NCI explanation for progression-free survival with overall survival data |
| Plain-language explanation of progression-free survival | Experimental | Not described Receives: Other: Plain-language explanation of progression-free survival |
| Plain-language explanation of progression-free survival with overall survival data | Experimental | Not described Receives: Other: Plain-language explanation of progression-free survival with overall survival data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
Compared to standard treatment, do patients with advanced kidney cancer live longer when treated with Velotrex?
- Response options: definitely yes, probably yes, probably no, definitely no
Measured: Assessed immediately after the intervention
Secondary outcomes (1)
Perceptions of drug benefits and risks
How would you describe the benefits of Velotrex?
- Very large, large, moderate, small, very small to none
Do you think the benefits of Velotrex outweigh the side effects? - Response options: definitely yes, probably yes, probably no, definitely no
Which treatment would you recommend to a patient with kidney cancer
- Response options: Velotrex, standard treatment
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 posted28 Jul 2026
- Study start1 Aug 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
- NCT07731425
- Sponsor's protocol ID
- 714377A
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07731425
- Acronym / sponsor ID
- 714377A
- Conditions
- Cancer
- Keywords
- cancer, prescription drugs, progression-free survival
- 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
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 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 whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs
Detailed description
Progression-free survival (PFS) (the time until a tumour grows, spreads, or the patient dies) is among the most common outcomes supporting the approval of new cancer drugs. Likely owing to similar terminology and the use of the word 'survival', patients often confuse PFS with overall survival, which may lead to treatment decisions that are not aligned with patients' individual preferences. Alternative descriptions of PFS that acknowledge the absence of a survival benefit may improve understanding.
This randomized controlled trial will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs, since patients may only understand the distinction between these outcomes when they are presented with data on both. Three alternative descriptions for PFS will be compared, including those used by the FDA, the National Cancer Institute, and a plain-language version that was developed drawing on prior work about communicating PFS. This study will also compare the additive effect of overall survival data for each alternative description of PFS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FDA explanation for progression-free survival (control) | Placebo comparator | Other: FDA explanation for progression-free survival (control) |
| FDA explanation for progression-free survival with overall survival data | Experimental | Other: FDA explanation for progression-free survival with overall survival data |
| NCI explanation for progression-free survival | Experimental | Other: NCI explanation for progression-free survival |
| NCI explanation for progression-free survival with overall survival data | Experimental | Other: NCI explanation for progression-free survival with overall survival data |
| Plain-language explanation of progression-free survival | Experimental | Other: Plain-language explanation of progression-free survival |
| Plain-language explanation of progression-free survival with overall survival data | Experimental | Other: Plain-language explanation of progression-free survival with overall survival data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- US adults with a current or former cancer diagnosis (excluding nonmelanoma skin cancer)
- US adults 18 years of age and older, fluent in English, and residing in the United States.
Key exclusion criteria (1 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 other 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 |
|---|---|---|
| FDA explanation for progression-free survival (control)Progression-free survival | Other | FDA explanation for progression-free survival (control) |
| FDA explanation for progression-free survival with overall survival dataThe description, 'progression-free survival', along with data on overall survival. | Other | FDA explanation for progression-free survival with overall survival data |
| NCI explanation for progression-free survivalThe description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'. | Other | NCI explanation for progression-free survival |
| NCI explanation for progression-free survival with overall survival dataThe description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse', along with data on overall survival. | Other | NCI explanation for progression-free survival with overall survival data |
| Plain-language explanation of progression-free survivalThe description, 'the length of time until a test showed the cancer grew, spread, or worsened'. | Other | Plain-language explanation of progression-free survival |
| Plain-language explanation of progression-free survival with overall survival dataThe description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival. | Other | Plain-language explanation of progression-free survival with overall survival data |
Primary outcome
Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
Time frame: Assessed immediately after the intervention
Compared to standard treatment, do patients with advanced kidney cancer live longer when treated with Velotrex? - Response options: definitely yes, probably yes, probably no, definitely no
1 secondary outcome
Perceptions of drug benefits and risks
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 28 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDA explanation for progression-free survival with overall survival data, NCI explanation for progression-free survival and NCI explanation for progression-free survival with overall survival data in people with Cancer, run by London School of Economics and Political Science at 1 site in United States.
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 2 inclusion and 1 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 28 Jul 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 States. 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?
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?
Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival (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 28 Jul 2026.