Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:25 PM
Study NCT ID:
NCT07412002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of End-of-Life Care for Children With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1190}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of end of life (EOL) care', 'timeFrame': 'Up to study completion, an average of 4 years', 'description': 'Is a composite measure evaluated as the percent of applicable measures with high-quality care for each patient. For each child, will calculate the percent of measures relevant to that patient for which they met the criteria for high-quality care. Of note, not all measures will apply to every patient (e.g., assessment of sibling support will only apply to those with siblings). EOL quality will be treated as a continuous variable and will be modeled using linear mixed effects models with COG site included as a random effect. Models will be adjusted for key demographic (child: death age, race, ethnicity, insurance, biologic sex; parent: age, race, ethnicity, relationship to child, biologic sex) and clinical factors (cancer diagnosis, time from diagnosis to death, relapse status, clinical trial enrollment, cause of death, palliative care team at primary treatment site).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Childhood Hematopoietic and Lymphatic System Neoplasm', 'Childhood Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': 'This study examines the role of access to care, patient/family interactions with the healthcare system, and stress in explaining variations in quality of end of life care. The data collected from this study may help researchers develop a model for identifying patients at risk of low quality end of life care as well as recommendations for potential future interventions.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Examine the role of access to care, patient/family healthcare interactions, and stress in variation in quality of end-of-life (EOL) care.\n\nOUTLINE: This is an observational study.\n\nPART 1: The medical records of deceased patients are reviewed on study.\n\nPART 2: Bereaved parents complete a survey and may participate in an interview on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bereaved parents of an eligible deceased COG registered index child patient previously enrolled on Stratum 1 of APEC14B1, Project:EveryChild', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Index Child (COG Registered Patient):\n\n * Must be deceased\n * \\< 18 years old at time of death\n * Diagnosed with any oncologic condition\n * History of enrollment on Stratum 1 of APEC14B1, Project:EveryChild\n\n * Note: history of treatment on a COG therapeutic trial is not required\n * Resided in the United States, including Puerto Rico, as evidenced by most recent address, at the time of death\n\nBereaved Parent(s):\n\n* Must be a parent, legal guardian, or caregiver (biological or non-biological) of an eligible Index Child enrolled on APEC14B1 with current Consent to Future Contact\n* Self-reported confirmation of familiarity with the care received by the Index Child in the last month of their life\n* Bereaved parent must understand English or Spanish (written and/or spoken)\n* Must be a parent/guardian/key contact from the Index Child's APEC14B1 Future Contact study record or must be referred by one of the APEC14B1 contacts\n* Bereaved parent must be \\>= 18 years old at the time of ALTE24C1 study enrollment\n\nRegulatory Requirements:\n\n* Bereaved parent must provide verbal or implied informed consent\n* For all participants, all institutional, FDA, and NCI requirements for human studies must be met"}, 'identificationModule': {'nctId': 'NCT07412002', 'briefTitle': 'Quality of End-of-Life Care for Children With Cancer', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Quality of End-of-Life Care for Children With Cancer: A COG Groupwide Observational Study', 'orgStudyIdInfo': {'id': 'ALTE24C1'}, 'secondaryIdInfos': [{'id': 'NCI-2026-00574', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ALTE24C1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'COG-ALTE24C1', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'ALTE24C1', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'R37CA296615', 'link': 'https://reporter.nih.gov/quickSearch/R37CA296615', 'type': 'NIH'}, {'id': 'UG1CA189955', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189955', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational part 1', 'description': 'The medical records of deceased patients are reviewed on study.', 'interventionNames': ['Other: Non-Interventional Study']}, {'label': 'Observational part 2', 'description': 'Bereaved parents complete a survey and may participate in an interview on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'otherNames': ['Non-Interventional Observational Study', 'Noninterventional (Observational) Study'], 'description': 'Non-interventional study', 'armGroupLabels': ['Observational part 1', 'Observational part 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emily E Johnston', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}