Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05826756
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2023-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-31', 'size': 400153, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-26T16:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact of the pandemic on access to treatment', 'timeFrame': 'Baseline survey - Temporary COVID-19 module', 'description': 'Exploratory descriptive analyses to understand the concerns participants who enrolled in 2020 and 2021 experienced with respect to their treatment and COVID-19'}], 'primaryOutcomes': [{'measure': 'Explore guideline concordant care', 'timeFrame': 'From baseline and assessed monthly up to end of study (up to approximately 12months)', 'description': '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.'}, {'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)', 'description': '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.\n\nScores 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.'}, {'measure': 'Explore impacts of different classes of therapies', 'timeFrame': 'From baseline and assessed monthly up to end of study (up to approximately 12months)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Lung Cancer Patients', 'Caregivers']}, 'descriptionModule': {'briefSummary': '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.\n\nWhat does participation involve?\n\n1. Emailing the study team to learn more and get access to the study website.\n2. Once a month for 12 months you will receive a survey by email.\n3. Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.', 'detailedDescription': "PEER is an international study, that is Institutional Review Board (IRB) approved and General Data Protection Regulation (GDPR) compliant.\n\nThe 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).\n\nStudy 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.\n\nSummarized 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with self-reported lung cancer diagnosis or caregiver of someone with a self-reported lung cancer diagnosis (patient has to be alive)\n* Ability to read and answer questions in English\n* Access and ability to use a computer or other internet-connected device\n\nExclusion Criteria:\n\n* Younger than 18\n* 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.\n* Not able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05826756', 'acronym': 'PEER', 'briefTitle': 'Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting', 'organization': {'class': 'OTHER', 'fullName': 'LUNGevity Foundation'}, 'officialTitle': 'Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting', 'orgStudyIdInfo': {'id': 'LUNGevity-2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '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).', 'interventionNames': ['Other: There are no interventions in this study. All participants complete online surveys.']}, {'label': 'Caregivers', 'description': 'Family and friends who provide care for someone who has been diagnosed with lung cancer', 'interventionNames': ['Other: There are no interventions in this study. All participants complete online surveys.']}], 'interventions': [{'name': 'There are no interventions in this study. All participants complete online surveys.', 'type': 'OTHER', 'otherNames': ['Other'], 'description': 'There are no interventions in this study. All participants complete online surveys.', 'armGroupLabels': ['Caregivers', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bellinda King-Kallimanis, PhD', 'role': 'CONTACT', 'email': 'ProjectPEER@lungevity.org'}], 'facility': 'LUNGevity Foundation', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Tracey Grant, MS', 'role': 'CONTACT', 'email': 'ProjectPEER@lungevity.org', 'phone': '(312) 519-1322'}, {'name': 'Bellinda King-Kallimanis, PhD', 'role': 'CONTACT', 'email': 'ProjectPEER@lungevity.org'}], 'overallOfficials': [{'name': 'Upal Basu Roy, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUNGevity Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LUNGevity Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Blueprint Medicines Corporation', 'class': 'INDUSTRY'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'G1 Therapeutics, Inc.', 'class': 'INDUSTRY'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Janssen, LP', 'class': 'INDUSTRY'}, {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}