Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04235556
Status:
UNKNOWN
Last Update Posted:
2022-05-13
First Post:
2019-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrated Care Pathway in Oncology (PASSION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-12', 'studyFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time between the first appointment with the oncologist and the beginning of antitumoral treatment.', 'timeFrame': '6 months', 'description': 'Delay of health care'}], 'secondaryOutcomes': [{'measure': 'Patients satisfaction', 'timeFrame': '6 months', 'description': 'Satisfaction of patients with OUT-PATSAT35 questionnaire (out-patient satisfaction) : Likert type scale with 5 ordered modalities (bad to excellent), rated from 1 to 5.'}, {'measure': 'Health care teams satisfaction', 'timeFrame': '6 months', 'description': 'Satisfaction of health care teams : qualitative questionnaire with 4 ordered modalities (very satisfied to not satisfied)'}, {'measure': 'Rate of emergency consultations and hospitalizations', 'timeFrame': '6 months', 'description': 'Need for unexpected health care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['care pathway', 'satisfaction', 'oncology', 'treatment delay'], 'conditions': ['Colon Cancer', 'Gastric Cancer', 'Pancreatic Cancer', 'Thoracic Neoplasms', 'Breast Cancer', 'Ovarian Cancer', 'Bladder Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': "A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).\n\nThe aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.\n\nThe second aim is to assess the satisfaction of patients and health care teams.", 'detailedDescription': 'PASSION is a french monocentric study.\n\nFor the retrospective cohort, patient will be selected through the use of data warehouse available on the HEGP.\n\nFor the prospective cohort, patient will be included according to the selection criteria.\n\nEach patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy.\n\nFor both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the HEGP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective cohort: patients treated at the Hôpital Européen Georges Pompidou in 2015 and 2017.\n\nProspective cohort:\n\n* Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer\n* First appointment for cancer care at the Hôpital Européen Georges Pompidou\n* Ile de France resident\n* All appointments planned at the Hôpital Européen Georges Pompidou\n* Intravenous antitumoral treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer\n* First appointment for cancer care at the Hôpital Européen Georges Pompidou\n* Intravenous antitumoral treatment\n\nExclusion Criteria:\n\n* Medical care non covered by social welfare\n* Radiochemotherapy\n* Death in the 6 months following first oncological appointment or absence of medical care in the year following the first oncological appointment'}, 'identificationModule': {'nctId': 'NCT04235556', 'acronym': 'PASSION', 'briefTitle': 'Integrated Care Pathway in Oncology (PASSION)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers', 'orgStudyIdInfo': {'id': 'APHP190973'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Historic cohort', 'description': 'Retrospective cohort of patients that were treated in the Hôpital Européen Georges Pompidou before the creation of the care pathway unit.'}, {'label': 'Prospective cohort', 'description': 'All consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start.', 'interventionNames': ['Behavioral: Care pathway unit']}], 'interventions': [{'name': 'Care pathway unit', 'type': 'BEHAVIORAL', 'description': 'Patients from the prospective cohort will have their health care scheduled by the care pathway unit.', 'armGroupLabels': ['Prospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpital européen Georges-Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Virginie Bichon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP, Hôpital Européen Georges Pompidou, Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'one year after the last publication', 'ipdSharing': 'YES', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.\n\nTeams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'MSD France', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}