Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT05129059
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081842', 'term': 'Logotherapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'meaning in life', 'timeFrame': 'baseline and 8 weeks', 'description': 'Meaning in life scale is a validated, 7-points Likert type scale with 2 dimensions. Possible scores range from 5 to 35 for each dimensions. Change= score of present meaning subscale\\> searched meaning subscale (8 week subscale-baseline subscale'}, {'measure': 'dignity', 'timeFrame': 'baseline and 8 weeks', 'description': 'The Patient Dignity Inventory is a valid, 5-points Likert type scale with 5 dimensions. Possible scores range from 25-125. Change= Lower score from the patient dignity inventory at the end of intervention compared to baseline.'}, {'measure': 'chronic sorrow', 'timeFrame': 'baseline and 8 weeks', 'description': 'Prolonged grief disorder scale-patient form is a valid, 5-points Likert type scale. Possible scores range from 12 to 60. Change= Lower score from the scale at the end of intervention compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['logotherapy', 'nursing', 'meaning in life', 'chronic sorrow', 'dignity'], 'conditions': ['Palliative Care', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '39138762', 'type': 'DERIVED', 'citation': 'Eskigulek Y, Kav S. Effect of logotherapy counseling program on chronic sorrow, dignity, and meaning in life of palliative care patients: a randomized controlled trial. Support Care Cancer. 2024 Aug 13;32(9):587. doi: 10.1007/s00520-024-08792-w.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.', 'detailedDescription': 'Palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. Logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. In this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated.\n\nIn this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHospitalized patients due to advanced cancer Patients informed of cancer diagnosis at least 1 month Patients reporting to have chronic sorrow Patients with palliative performance scale score at least 50% Patients having life expectancy more than 6 months Patients who volunteered to participate in the study and signed written informed consent\n\nExclusion Criteria:\n\nClinically diagnosed mental disorder Patients with palliative performance scale score \\< 40%'}, 'identificationModule': {'nctId': 'NCT05129059', 'briefTitle': 'Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Effect of Logotherapy Counseling Programme on Dignity and Chronic Sorrow in Palliative Care Patients Experiencing Chronic Sorrow', 'orgStudyIdInfo': {'id': 'KA21/276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Logotherapy', 'description': 'Participants will receive individual logotherapy counseling by the investigator for 8 visits in 4 weeks.', 'interventionNames': ['Other: Logotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will receive routine care.'}], 'interventions': [{'name': 'Logotherapy', 'type': 'OTHER', 'description': 'Logotherapy is a method of finding meaning with three basic principles. The first principle is that life is meaningful in every situation , even in the most desperate moments. The second principle is that the main source of motivation is the desire to find meaning in life. The third is that an individual is free to choose his own attitude even in the worst conditions.', 'armGroupLabels': ['Logotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Yasemin Eskigülek', 'role': 'CONTACT', 'email': 'yaseminuslu12@gmail.com', 'phone': '+905447887405'}], 'overallOfficials': [{'name': 'Yasemin Eskigülek', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University'}, {'name': 'Sultan Kav', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baskent University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, MSN', 'investigatorFullName': 'Yasemin Eskigülek', 'investigatorAffiliation': 'Baskent University'}}}}