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

Caregivers Clinical Trial

— PEER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826756
• Other study ID #: LUNGevity-2020-01
• Status: Recruiting
• Start date: August 15, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: LUNGevity Foundation
• Contact: Tracey Grant, MS
• Phone: (312) 519-1322
• Email: ProjectPEER[@]lungevity.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregivers
• Lung Cancer Patients
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	LUNGevity Foundation	Bethesda	Maryland

Sponsors (14)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of the pandemic on access to treatment	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
Primary	Explore guideline concordant care	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)
Primary	Explore patient-reported functioning, symptoms, side effects and overall quality of life	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)
Primary	Explore impacts of different classes of therapies	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)