Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-02 @ 5:24 AM
Study NCT ID:
NCT03698656
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2018-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period', 'timeFrame': '6-8 months', 'description': 'Number of patients having entered the study with regards to the number of the contacted patients, and number of patients having completed the six-eight month study with regards to the patients having entered the study'}], 'secondaryOutcomes': [{'measure': 'Rate of entire completion of quality of life scales', 'timeFrame': '6-8 months', 'description': 'Rate of entire completion of functional assessment of cancer therapy - general and The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being 12 items scales whose values will be used in order to determine the sample size of a further randomised controlled trial'}, {'measure': 'Number of contacted patients with regards to the number of eligible hospitalized patients', 'timeFrame': '6-8 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spiritual dimension', 'Hematologic cancer', 'Acute leukemia', 'Lymphoma', 'Nurse interview', 'Quality of life'], 'conditions': ['Acute Leukemia', 'Lymphoma']}, 'descriptionModule': {'briefSummary': "Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer", 'detailedDescription': 'Patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period.\n\nThe intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). Quality of life (FACT-G) and spiritual well-being (FACIT-SP12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview).\n\nThis pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute leukaemia or lymphoma during the first month after diagnosis or after first relapse hospitalised in Toulouse Cancer University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse\n* More than 17 years old\n* French language\n* Having signed informed consent\n\nExclusion Criteria:\n\n* Patients requiring palliative care\n* Important psychic vulnerability or severe psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT03698656', 'acronym': 'SPIEVIE', 'briefTitle': "Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers.", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': "Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study", 'orgStudyIdInfo': {'id': 'RC31/17/0332'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spiritual Interview', 'type': 'BEHAVIORAL', 'description': 'Three patient interviews (45 to 60 minutes) will be conducted by the study nurse at the beginning of the study and approximately 2 and 4 month later, according to the program of the medical care. Each interview will be conducted according the active listening method of Carl Rogers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Valérie FLOUCAUD, IDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}