Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT07219251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2025-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Engagement of Veterans With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistician analyzing the data will be masked from the randomization assignment. The principal investigator overseeing the trial will have access to the data but will also be masked from randomization assignment.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'intervention vs. usual care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 194}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-10-17', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': 'At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment', 'description': 'Change in Health-related quality of life using the 36-item validated Functional Assessment of Cancer Therapeutics-Lung (FACT-L) survey.'}], 'secondaryOutcomes': [{'measure': 'Emergency Department Visits (Self-reported and Chart Review)', 'timeFrame': 'From baseline (time of enrollment) to 12 Months post-enrollment', 'description': 'Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after enrollment.'}, {'measure': 'Hospitalization Visits (Self-reported and Chart Review)', 'timeFrame': 'From baseline (time of enrollment) to 12 months post-enrollment', 'description': 'Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after enrollment.'}, {'measure': 'Patient Activation Measure (PAM-10).', 'timeFrame': 'At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment', 'description': 'Change in patient activation using 10-item validated survey Patient Activation Measure (PAM-10) assessing patient activation in their health and health care .'}, {'measure': 'Patient-reported anxiety and depression', 'timeFrame': 'At baseline, 3, 6, 9 and 12 months post-enrollment', 'description': 'Patient-reported anxiety and depression using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression scales'}, {'measure': 'Documentation of goals of care discussions (Chart Review)', 'timeFrame': 'At baseline, 3, 6, 9 and 12 months post-enrollment', 'description': 'Documentation of goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, 9 and 12 months after enrollment.'}, {'measure': 'Palliative Care Use (Self-reported and Chart Review)', 'timeFrame': 'From baseline (time of enrollment) to 12 months post-enrollment', 'description': 'Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.'}, {'measure': 'Hospice Care Use (Self-reported and Chart Review)', 'timeFrame': 'From baseline (time of enrollment) to 12 months post-enrollment', 'description': 'Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung', 'cancer'], 'conditions': ['Lung Cancer (NSCLC)', 'Lung Adenocarcinoma', 'Lung Cancer, Non-Small Cell', 'Lung Carcinoma', 'Lung Cancer, Small Cell', 'Lung Adenocarcinoma With Bronchiolo-alveolar Feature']}, 'descriptionModule': {'briefSummary': 'This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.', 'detailedDescription': 'This study aims to evaluate whether a lay health worker who provides education and support regarding goals of care and symptom management can improve health-related quality of life among Veterans with newly diagnosed lung cancer and those receiving treatment or who have completed treatment within 12 months as compared to usual care. We will also determine whether the intervention reduces acute care use and explore effects on anxiety and depression, patient activation, and goals of care communication. This knowledge is important as it will help to improve care for Veterans with lung cancer.\n\nPRIMARY OBJECTIVES:\n\ni.) Health-related quality of life\n\nSECONDARY OBJECTIVES:\n\ni.) acute care use ii.) patient activation iii.) anxiety and depression iv.) documentation of goals of care (GoC) v.) palliative care use vi.) hospice use\n\nOUTLINE: The study will enroll and randomize 1:1 a total of 194 Veterans diagnosed with lung cancer (any stage).\n\nArm A: Participants randomized to the usual care group will receive usual care provided by their oncology clinical team.\n\nArm B: Participants randomized to the LHW group will receive usual care provided by their oncology clinical team and also receive weekly telephone calls with a trained lay health worker to assist with healthcare planning, symptom management, and discussions about care preferences and goals for 6 months.\n\nAll participants regardless of group randomization, will be required to complete surveys at the start of the study and at 3-month intervals for 12 months (i.e., at enrollment, 3 months, 6 months, 9 months, and 12 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Veteran patients with diagnosis of any stage of lung cancer;\n2. 18 years of age or older;\n3. English- or Spanish-speaking;\n4. can self-administer questionnaires in English or Spanish;\n5. valid telephone number;\n6. receiving oncology care at participating sites;\n7. currently newly diagnosed or receiving or having completed systemic anti-cancer therapy and/or radiation therapy within 12 months, defined as oral, injection, or intravenous therapy (chemotherapy, targeted therapy, or immunotherapy)\n\nExclusion Criteria:\n\n1. no capacity to consent;\n2. actively receiving hospice care'}, 'identificationModule': {'nctId': 'NCT07219251', 'acronym': 'EVLC', 'briefTitle': 'Engagement of Veterans With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Palo Alto Veterans Institute for Research'}, 'officialTitle': 'Engagement of Veterans With Lung Cancer (EVLC)', 'orgStudyIdInfo': {'id': 'IRB-79923'}, 'secondaryIdInfos': [{'id': 'LC240650', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care - Arm A', 'description': 'Patients randomized to this group will receive usual care provided by their oncology(or primary) clinical team.', 'interventionNames': ['Other: Usual Care Group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Lay Health Worker (LHW) - Arm B', 'description': 'Participants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay health worker (LHW) to assist with healthcare planning, symptom management, and discussions about care preferences and goals.', 'interventionNames': ['Behavioral: Lay Health Worker (LHW) Planning']}], 'interventions': [{'name': 'Lay Health Worker (LHW) Planning', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to the LHW group will receive usual care provided by their oncology (or primary) clinical team along with an initial 30-minute telephone call with the LHW from Palo Alto, followed by weekly 15-minute phone calls (or as needed) for 6months. These calls are designed to assist with healthcare planning, symptom management, and discussions about care preferences and goals.', 'armGroupLabels': ['Intervention Lay Health Worker (LHW) - Arm B']}, {'name': 'Usual Care Group', 'type': 'OTHER', 'otherNames': ['Usual Care'], 'description': 'Participants randomized to the usual care group will receive usual care provided by their oncology clinical team. These teams have been trained in symptom assessment, goals-of-care (GoC) discussions, and documentation of such clinical services. As part of usual care, participants may engage in symptom and GoC discussions at any time, initiated by either the patient or the clinician.', 'armGroupLabels': ['Usual Care - Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Madhuri Agrawal, MS', 'role': 'CONTACT', 'email': 'madhuri.agrawal@va.gov', 'phone': '650-304-7744'}], 'facility': 'Veterans Affairs Palo Alto Health Care System (VAPAHCS)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Manali I Patel, MD MPH MS', 'role': 'CONTACT', 'email': 'manalip@stanford.edu', 'phone': '6504935000'}, {'name': 'Madhuri Agrawal, MS', 'role': 'CONTACT', 'email': 'madhuri.agrawal@va.gov', 'phone': '650-304-7744'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palo Alto Veterans Institute for Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Oncologist and Investigator', 'investigatorFullName': 'Manali Patel', 'investigatorAffiliation': 'VA Palo Alto Health Care System'}}}}