Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04738305
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2021-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Dignity Therapy Intervention on Cancer Patients in Charge to an Hospital Palliative Care Unit.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096225', 'term': 'Dignity Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': '1 year', 'description': 'The number of participants who sign the informed consent form divided by the number who are asked to participate in the study'}, {'measure': 'Retention rate', 'timeFrame': '1 year', 'description': 'The number of participants who performed the post intervention assesment divided by the number of enrolled one.'}, {'measure': "Professionals' experience in implementing DT", 'timeFrame': '12-18 months', 'description': 'Semi-structured interviews administered to the three nurses that implemented the higher number of DT interventions. Interview were performed after the last patient completed the post intervention assessment.'}], 'secondaryOutcomes': [{'measure': 'Patient dignity-related', 'timeFrame': 'Baseline; day 62', 'description': 'Patient Dignity Inventory (Italian version). Scale range 25-125, higher value means higher dignity-related distress.'}, {'measure': 'Patient feedback', 'timeFrame': 'day 62', 'description': 'The acceptability of Dignity Therapy was assessed by the Italian version of "Dignity Therapy Patient Feedback Questionnaire" survey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hospital palliative care unit'], 'conditions': ['Dignity', 'Advanced Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Chochinov HM. Terapia della dignità : parole per il tempo che rimane. Il pensiero scientifico, 2015.'}, {'pmid': '34399737', 'type': 'DERIVED', 'citation': 'Nunziante F, Tanzi S, Alquati S, Autelitano C, Bedeschi E, Bertocchi E, Dragani M, Simonazzi D, Turola E, Braglia L, Masini L, Di Leo S. Providing dignity therapy to patients with advanced cancer: a feasibility study within the setting of a hospital palliative care unit. BMC Palliat Care. 2021 Aug 16;20(1):129. doi: 10.1186/s12904-021-00821-3.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study was to asses feasibility and acceptability of a nurse delivered Dignity Therapy (DT) intervention on advanced cancer patients referring to an Hospital palliative care unit. To achieve this aim a mixed-method approach using before and after evaluation and semi-structured interviews has been used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced cancer patients\n* over 3 months life expectancy\n* referring to hospital palliative care unit\n* performance status (Eastern Cooperative Oncology Group - ECOG) between 0 and 2\n* awareness of being affected by an incurable cancer\n* cognitive ability to read, understand and fill in a questionnaire in Italian\n* willing and able to give written informed consent\n\nExclusion Criteria:\n\n* \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT04738305', 'briefTitle': 'Feasibility of Dignity Therapy Intervention on Cancer Patients in Charge to an Hospital Palliative Care Unit.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': "Feasibility and Acceptability of a Dignity Therapy Intervention on Palliative Care Program's Cancer Patients Referring to a Medical Oncology Ward.", 'orgStudyIdInfo': {'id': '2016/0007193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dignity Therapy Intervention', 'description': 'All the patients that accepted to participate in the study were provided with Dignity Therapy Intervention. A short-term intervention aimed at reducing existential distress of patients facing with advanced illness.', 'interventionNames': ['Other: Dignity Therapy']}], 'interventions': [{'name': 'Dignity Therapy', 'type': 'OTHER', 'description': 'The Italian version Dignity Therapy intervention (Chochinov HM 2015) has been delivered. Intervention questions were not previously delivered to patients.\n\nDT interview was provided to patients by Specifically trained Nurses. Interviews were audio-recorded and transcribed then revised by the patients to develop the final Generativity Document. Generativity Document was delivered to patients that could share it with their loved ones.', 'armGroupLabels': ['Dignity Therapy Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42123', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Azienda USL - IRCCS di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Francesca Nunziante', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL - IRCCS di Reggio Emilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}