Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival

July 23, 2026 updated by: Avi Cherla, London School of Economics and Political Science

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard Medical School and Harvard Pilgrim Health Care Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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)
  • US adults 18 years of age and older, fluent in English, and 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 other inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: FDA explanation for progression-free survival (control)
Other: FDA explanation for progression-free survival (control)
Progression-free survival
Experimental: FDA explanation for progression-free survival with overall survival data
Other: FDA explanation for progression-free survival with overall survival data
The description, 'progression-free survival', along with data on overall survival.
Experimental: NCI explanation for progression-free survival
Other: NCI explanation for progression-free survival
The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
Experimental: NCI explanation for progression-free survival with overall survival data
Other: NCI explanation for progression-free survival with overall survival data
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.
Experimental: Plain-language explanation of progression-free survival
Other: Plain-language explanation of progression-free survival
The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
Experimental: Plain-language explanation of progression-free survival with overall survival data
Other: Plain-language explanation of progression-free survival with overall survival data
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceptions of drug benefits and risks
Time Frame: Assessed immediately after the intervention

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
Assessed immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Economics and Political Science

Collaborators

Harvard Medical School and Harvard Pilgrim Health Care Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 23, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 714377A

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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