Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT02854293
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of questions asked or the concerns expressed that elicit a medical comment by the patient or the family during the palliative care consultation.', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'HADS (Hospital Anxiety and Depression Scale) anxiety and depression score', 'timeFrame': 'one month'}, {'measure': 'QLQC-15Pal palliative quality of life score', 'timeFrame': 'one month', 'description': 'The EORTC QLQ-C15-PAL is a questionnaire developed to assess the quality of life of palliative cancer care patients'}, {'measure': 'MB coping questionnaire score', 'timeFrame': 'one month', 'description': 'The Brief COPE is the abbreviated version of the COPE Inventory and assesses dispositional as well as situational coping efforts . The 28-item Brief COPE (consisting of 14 subscales) has acceptable psychometric properties and has been used extensively to examine the relationship between various coping strategies and psychological outcomes'}, {'measure': 'Two 5-point Likert scales on information needs and satisfaction with medical information', 'timeFrame': 'one month'}, {'measure': 'Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['palliative care', 'cancer', 'quality of life'], 'conditions': ['Metastatic Cancer', 'Palliative Care']}, 'referencesModule': {'references': [{'pmid': '32739563', 'type': 'DERIVED', 'citation': 'Bouleuc C, Savignoni A, Chevrier M, Renault-Tessier E, Burnod A, Chvetzoff G, Poulain P, Copel L, Cottu P, Pierga JY, Bredart A, Dolbeault S. A Question Prompt List for Advanced Cancer Patients Promoting Advance Care Planning: A French Randomized Trial. J Pain Symptom Manage. 2021 Feb;61(2):331-341.e8. doi: 10.1016/j.jpainsymman.2020.07.026. Epub 2020 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient over the age of 18 years,\n* Patient who has signed the informed consent form after being given a written information sheet\n* Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy\n* Patient referred to the palliative care team.\n* French-speaking Patient\n\nExclusion criteria:\n\n* Cognitive disorders\n* Documented psychiatric disorders or marked psychological fragility'}, 'identificationModule': {'nctId': 'NCT02854293', 'acronym': 'QUEPAL', 'briefTitle': 'Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation', 'orgStudyIdInfo': {'id': 'IC 2011-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Booklet-Question List (BQL) group', 'description': '76 patients', 'interventionNames': ['Other: Booklet-Question List']}, {'label': 'control group', 'description': 'Conventional palliative management\n\n76 patients'}], 'interventions': [{'name': 'Booklet-Question List', 'type': 'OTHER', 'description': 'Booklet-Question List (BQL) proposed in palliative cares, divided into 8 chapters, given to the patient before the first palliative care consultation.\n\nProviding a list of questions to patients and their families without any obligations allows individual adaptation of information; patients or families who are afraid of asking these questions can take advantage of this opportunity, while respecting the need to avoid these subjects for other patients', 'armGroupLabels': ['Booklet-Question List (BQL) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Léon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '54519', 'city': 'Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Hopital René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '65000', 'city': 'Tarbes', 'country': 'France', 'facility': "Polyclinique de l'Ormeau", 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}], 'overallOfficials': [{'name': 'Carole Bouleuc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Curie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}