Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT04412135
Status:
UNKNOWN
Last Update Posted:
2020-06-02
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026443', 'term': 'Spiritual Therapies'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FACIT-Sp questionnaire', 'timeFrame': '15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Cancer']}, 'descriptionModule': {'briefSummary': "The management of patients with malignant hemopathy is based on comprehensive management. In this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central. Spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not. Although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'hematologic cancer patient and family member', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia) and in treatment;\n* Patients who speak and read French;\n* Patients in general condition (physical and mental) judged emotionally and physically fit by the referring nurse to answer the questionnaires;\n* Patients benefiting from a social security scheme,\n* Patients who signed the non-objection form after being informed of the study,\n\nfamily person:\n\n* Have been designated by the patient as being the loved one they wish to include with them;\n* Aged ≥ 18 years;\n* Fluent in and reading French;\n* Having signed the non-objection form after being informed of the study.\n\nExclusion Criteria:\n\n* Patients in recurrence / progress or in remission of cancer;\n* Patients in the terminal phase of the disease.\n\nFamily person:\n\nperson in the curative phase of cancer'}, 'identificationModule': {'nctId': 'NCT04412135', 'acronym': 'SPIRIHEMATO', 'briefTitle': 'The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality During the Initial Healing Phase', 'orgStudyIdInfo': {'id': '87RI19_0050'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spirituality', 'type': 'OTHER', 'description': 'Patients will take three questionnaires (FACIT-Sp, Euroqol 5 dimensions and ESAS)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jean TONIOLO', 'role': 'CONTACT', 'email': 'jean.toniolo@chu-limoges.fr', 'phone': '+33 5 55 05 67 55'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}