Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-29 @ 3:23 AM
Study NCT ID:
NCT06909968
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze the appropriateness of progressive palliative care approach', 'timeFrame': '55 months', 'description': 'Initially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.'}, {'measure': 'Evaluating PaP (Palliative Prognostic) and NECPAL CCOMS-ICO(©) scores to analyze timeliness of progressive palliative care approach', 'timeFrame': '55 months', 'description': 'Initially simultaneously with ongoing disease-oriented treatment and subsequently as the only modality of care to avoid aggressiveness of care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['palliative care', 'appropriateness', 'cancer', 'chronic pulmonary failure', 'chronic renal failure'], 'conditions': ['Cancer', 'Chronic Renal Failure', 'Chronic Obstructive Pulmonary Disease', 'Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.', 'detailedDescription': 'This is a prospective observational study done on 3 patient populations (cancer, chronic pulmonary and renal disease). All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. The primary objective is to analyze appropriateness and timeliness of progressive palliative care approach (initially simultaneously with ongoing disease-oriented treatment and subsequently possibly as the only modality of care to avoid aggressiveness of care) in patients with:\n\n* First diagnosis of advanced metastatic non-small cell lung cancer, or advanced gastric cancer or advanced pancreatic adenocarcinoma\n* advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).\n* advanced chronic renal failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Population A: cancer patients with first diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma.\n* Population B: patients with advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).\n* Population C: patients with advanced chronic renal failure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sex;\n* All ethnic background;\n* Age ≥18 years;\n* Subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;\n* Written informed consent;\n* Not receiving care from the palliative care service\n\nInclusion Criteria specific for POPULATION A:\n\n* Diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);\n* Life expectancy \\>2 months;\n\nInclusion Criteria specific for POPULATION B:\n\n* Diagnosis of chronic obstructive pulmonary disease (COPD) with at least two of these characteristics: age \\> 70 years, FEV1 \\<30 % predicted, oxygen-therapy dependency, \\> 1 admission/year in hospital for COPD exacerbated, congestive heart failure and/or other comorbidity, weight loss/cachexia, reduced functional autonomy, increase dependence.\n* or idiopathic pulmonary fibrosis (IPF) diagnosis with at least two of these characteristics: age \\> 70 years, histological pattern "UIP" (if known), dependence on oxygen-therapy, radiological aspect of "Honeycomb" to the HRTC of the thorax, reduced functional autonomy, increased dependence.\n\nInclusion Criteria specific for POPULATION C:\n\n\\- Diagnosis advanced chronic renal failure with at least two of these characteristics: age \\> 75 years, advanced malignancy, severe malnutrition, cardiac or pulmonary pathology terminal, Multiple Organ Failure in Intensive Care.'}, 'identificationModule': {'nctId': 'NCT06909968', 'briefTitle': 'Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS'}, 'officialTitle': 'Identification of Palliative Care Needs and Prognostic Factors of Survival in Tailoring Appropriate Interventions in Advanced Oncological, Renal and Pulmonary Diseases', 'orgStudyIdInfo': {'id': 'IRST100.45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer patients', 'description': 'cancer patients with first diagnosis of inoperable locally advanced and/or metastatic non-small cell lung cancer, or gastric cancer or pancreatic adenocarcinoma', 'interventionNames': ['Other: palliative care']}, {'label': 'Chronic pulmonary failure', 'description': 'patients with advanced chronic respiratory failure, caused by chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF).', 'interventionNames': ['Other: palliative care']}, {'label': 'Chronic renal failure', 'description': 'patients with advanced chronic renal failure', 'interventionNames': ['Other: palliative care']}], 'interventions': [{'name': 'palliative care', 'type': 'OTHER', 'description': "As this study is intended to be observational (not interventional), the patient's medical record will be the source of all data to be recorded.\n\nNo additional procedures/patient visits should be planned in the study with respect to clinical practice.\n\nTwo tools will be used to to analyze appropriateness and timeliness of progressive palliative care approach: NECPAL CCOMS-ICO(©), specific for the assessment of needs in palliative care, and the PaP score, for the assessment of prognosis.", 'armGroupLabels': ['Cancer patients', 'Chronic pulmonary failure', 'Chronic renal failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40124', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'Rete Cure Palliative AUSL Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': "U.O. Nefrologia, Dialisi e Trapianto Renale, Policlinico Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': "U.O. Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '47121', 'city': 'Forlì', 'state': 'FC', 'country': 'Italy', 'facility': 'U.O. Nefrologia e Dialisi, Ospedale Morgagni-Pierantoni - Ospedale M. Bufalini', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '47014', 'city': 'Meldola', 'country': 'Italy', 'facility': 'IRST IRCCS UO Cure Palliative', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}], 'overallOfficials': [{'name': 'Marco C Maltoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRST IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}