Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting (PEER)

April 26, 2023 updated by: LUNGevity Foundation

LUNGevity Foundation, a non-profit lung cancer organization, wants to learn about living with lung cancer from the point of view of people with lung cancer and their family and friends who provide care. To do this, we have an online study designed to better understand how treatments people living with lung cancer receive impact their quality of life. Participants will complete surveys once a month for 12 months.

What does participation involve?

  1. Emailing the study team to learn more and get access to the study website.
  2. Once a month for 12 months you will receive a survey by email.
  3. Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PEER is an international study, that is Institutional Review Board (IRB) approved and General Data Protection Regulation (GDPR) compliant.

The study objective is to collect longitudinal data to facilitate a rigorous understanding of the diagnostic and treatment experiences of people diagnosed with lung cancer and to identify determinants of treatment heterogeneity. Study data will be used to understand the diagnostic and treatment pathways, explore patient-experience data in different domains (financial impact/quality of life/symptoms) and test the hypothesis that different classes of therapies (chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (eg., physical function).

Study participants will consent and register for the study and complete an initial baseline survey. They will then be followed for 12 months and receive a monthly survey (11 surveys in total) via email. The development of the surveys was guided by input from patients, clinicians, FDA experts, and incorporates questions from existing patient-reported outcomes (PRO) measures.

Summarized study results will also be posted on LUNGevity's website. External researchers will be able to apply to have limited access to de-identified data.

Study Type

Observational

Enrollment (Anticipated)

1300

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 Contact Backup

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

People who have been diagnosed with lung cancer and family and friends who care for someone with a lung cancer diagnosis. PEER is an international study, so participants can live anywhere as long as they meet the inclusion criteria.

Description

Inclusion Criteria:

  • Adults with self-reported lung cancer diagnosis or caregiver of someone with a self-reported lung cancer diagnosis (patient has to be alive)
  • Ability to read and answer questions in English
  • Access and ability to use a computer or other internet-connected device

Exclusion Criteria:

  • Younger than 18
  • Healthcare providers and healthcare professionals who provide care to lung cancer patients except for those who are themselves a patient or a caregiver to a loved one.
  • Not able to provide informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Individuals who have been diagnosed with lung cancer. Individuals with all stages of lung cancer and individuals who have reached no evidence of disease (NED).
Other: There are no interventions in this study. All participants complete online surveys.
There are no interventions in this study. All participants complete online surveys.
Other Names:
  • Other
Caregivers
Family and friends who provide care for someone who has been diagnosed with lung cancer
Other: There are no interventions in this study. All participants complete online surveys.
There are no interventions in this study. All participants complete online surveys.
Other Names:
  • Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore impacts of different classes of therapies
Time Frame: From baseline and assessed monthly up to end of study (up to approximately 12months)
Test whether different classes of therapies (e.g., chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (e.g., side effects, functioning). Both within and between patient experiences will be investigated. Results from Project PEER will be compared currently existing clinical trial data.
From baseline and assessed monthly up to end of study (up to approximately 12months)
Explore guideline concordant care
Time Frame: From baseline and assessed monthly up to end of study (up to approximately 12months)
Patient-reported treatments will be explored in relation to other clinical data provided (e.g., biomarker presence) and the National Comprehensive Cancer Network (NCCN) guidelines for those clinical characteristics at the time of treatment.
From baseline and assessed monthly up to end of study (up to approximately 12months)
Explore patient-reported functioning, symptoms, side effects and overall quality of life
Time Frame: From baseline and assessed monthly up to end of study (up to approximately 12months)

Patterns based on disease staging and treatment class will be explored using the European Organisation for Research and Treatment of Cancer Quality of Life 30-item questionnaire (EORTC QLQ-C30), the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), and a side effect questionnaire to explore these patient-reported outcomes.

Scores for the EORTC QLQ-C30 are transformed so that for each subscale the range is 0-100. For functioning subscales, higher scores indicate better functioning, and for symptoms higher scores indicate more symptom burden. Scores for the NSCLC-SAQ range from 0-20, with higher scores indicating more severe symptomology.
From baseline and assessed monthly up to end of study (up to approximately 12months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the pandemic on access to treatment
Time Frame: Baseline survey - Temporary COVID-19 module
Exploratory descriptive analyses to understand the concerns participants who enrolled in 2020 and 2021 experienced with respect to their treatment and COVID-19
Baseline survey - Temporary COVID-19 module

Collaborators and Investigators

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

Sponsor

LUNGevity Foundation

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company
Merck Sharp & Dohme LLC
Novartis
Takeda
AstraZeneca
Genentech, Inc.
Boehringer Ingelheim
Amgen
Jazz Pharmaceuticals
Janssen, LP
G1 Therapeutics, Inc.
Blueprint Medicines Corporation

Investigators

  • Principal Investigator: Upal Basu Roy, PhD, MPH, LUNGevity Foundation

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 (Actual)

August 15, 2020

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUNGevity-2020-01

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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