Lung Cancer PatientsPEERNCT05826756
Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting
An observational study of Lung Cancer Patients and Caregivers, run by LUNGevity Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Patients, Caregivers
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bellinda King-Kallimanis, PhD contact
United States1 site, 1 recruiting
- Recruiting
LUNGevity Foundation
Bethesda, Maryland, 20814
Bellinda King-Kallimanis, PhD, ProjectPEER@lungevity.org
About this study
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?
- Emailing the study team to learn more and get access to the study website.
- Once a month for 12 months you will receive a survey by email.
- Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.
Read the 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.
- Conditions
- Lung Cancer Patients, Caregivers
- Being tested
- There are no interventions in this study. All participants complete online surveys.
- 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
- Medical subject headings
- Lung Neoplasms, Tobacco Use, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions in this study. All participants complete online surveys.Other
Also called Other
There are no interventions in this study. All participants complete online surveys.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: There are no interventions in this study. All participants complete online surveys. | |
| Caregivers | Family and friends who provide care for someone who has been diagnosed with lung cancer Receives: Other: There are no interventions in this study. All participants complete online surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From baseline and assessed monthly up to end of study (up to approximately 12months)
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.
Measured: From baseline and assessed monthly up to end of study (up to approximately 12months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 Aug 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LUNGevity Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Upal Basu Roy, PhD, MPH, Principal investigator, LUNGevity Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826756
- Sponsor's protocol ID
- LUNGevity-2020-01
- Acronym
- PEER
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting
- ClinicalTrials.gov ID
- NCT05826756
- Acronym / sponsor ID
- PEER / LUNGevity-2020-01
- Conditions
- Lung Cancer Patients, Caregivers
- Keywords
- Lung cancer, Patient, Caregiver, Smoker, Non-smoker, Tobacco use, Tobacco exposure, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- LUNGevity FoundationUniversity, hospital or other
- Collaborators
- 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
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
- Emailing the study team to learn more and get access to the study website.
- Once a month for 12 months you will receive a survey by email.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: There are no interventions in this study. All participants complete online surveys.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). |
| Caregivers | – | Other: There are no interventions in this study. All participants complete online surveys.Family and friends who provide care for someone who has been diagnosed with lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There are no interventions in this study. All participants complete online surveys.Also: OtherThere are no interventions in this study. All participants complete online surveys. | Other | Caregivers, Patients |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer Patients
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bellinda King-Kallimanis, PhD contact
Upal Basu Roy, PhD, MPH principal investigator
LUNGevity Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Patients and Caregivers, run by LUNGevity Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracey Grant, MS ((312) 519-1322, ProjectPEER@lungevity.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore guideline concordant care (time frame: From baseline and assessed monthly up to end of study (up to approximately 12months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.