Clinical trial NCT05826756: Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting
Official title: Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Patients
Caregivers
Keywords: Lung cancer
Patient
Caregiver
Smoker
Non-smoker
Tobacco use
Tobacco exposure
Biomarker
Non-small cell lung cancer (NSCLC)
Small cell lung cancer (SCLC)
Quality of life
Treatment
Lead sponsor: LUNGevity Foundation
Sponsor class: OTHER
Collaborators: name: Amgen
name: AstraZeneca
name: Blueprint Medicines Corporation
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: Eli Lilly and Company
name: G1 Therapeutics, Inc.
name: Genentech, Inc.
name: Janssen, LP
name: Jazz Pharmaceuticals
name: Merck Sharp & Dohme LLC
name: Novartis
name: Takeda
First posted: 2023-04-24
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Explore guideline concordant care
timeFrame: From baseline and assessed monthly up to end of study (up to approximately 12months)
measure: Explore patient-reported functioning, symptoms, side effects and overall quality of life
timeFrame: From baseline and assessed monthly up to end of study (up to approximately 12months)
measure: Explore impacts of different classes of therapies
timeFrame: From baseline and assessed monthly up to end of study (up to approximately 12months)
Secondary outcomes:
Other outcomes:
measure: Impact of the pandemic on access to treatment
timeFrame: Baseline survey - Temporary COVID-19 module
Locations:
city: Bethesda
country: United States
facility: LUNGevity Foundation
state: Maryland
Study officials:
affiliation: LUNGevity Foundation
name: Upal Basu Roy, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: