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Not yet recruiting NCT07731425

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

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial

Overview

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.

Interventions

  • Other FDA explanation for progression-free survival (control)
    Progression-free survival
  • Other FDA explanation for progression-free survival with overall survival data
    The description, 'progression-free survival', along with data on overall 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'.
  • 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.
  • Other Plain-language explanation of progression-free survival
    The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Perceptions of drug benefits and risks [Time frame: Assessed immediately after the intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Harvard Medical School and Harvard Pilgrim Health Care Institute — Boston

Identifiers

NCT: NCT07731425 · 714377A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗