Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02051660
Status:
COMPLETED
Last Update Posted:
2019-05-24
First Post:
2014-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression module of the Patient Health Questionnaire (PHQ-9)', 'timeFrame': '6-months', 'description': 'A reliable and valid 9-item measure of depression.'}, {'measure': 'Beck Depression-Inventory II (BDI-II)', 'timeFrame': '6-months', 'description': 'A reliable and valid 21-item self-report instrument for evaluating the severity of depression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression', 'Psychological Distress']}, 'referencesModule': {'references': [{'pmid': '30887126', 'type': 'DERIVED', 'citation': 'Scheffold K, Philipp R, Vehling S, Koranyi S, Engelmann D, Schulz-Kindermann F, Harter M, Mehnert-Theuerkauf A. Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients. Support Care Cancer. 2019 Nov;27(11):4317-4325. doi: 10.1007/s00520-019-04744-x. Epub 2019 Mar 18.'}, {'pmid': '26286128', 'type': 'DERIVED', 'citation': 'Scheffold K, Philipp R, Engelmann D, Schulz-Kindermann F, Rosenberger C, Oechsle K, Harter M, Wegscheider K, Lordick F, Lo C, Hales S, Rodin G, Mehnert A. Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial. BMC Cancer. 2015 Aug 19;15:592. doi: 10.1186/s12885-015-1589-y.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.', 'detailedDescription': 'Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥18 years of age\n* Fluency in German\n* No cognitive impairment indicated in the medical record or by the attending oncologist\n* Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer) stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)\n* PHQ-9 depression score \\>=9 or Distress thermometer score \\>=5\n\nExclusion Criteria:\n\n* Major communication difficulties (including language barriers)\n* Inability to commit to the required 3-6 psychotherapy sessions\n* A score \\<20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion\n* A score \\<70 on the Karnofsky-Performance Status Scale, indicating high physical symptom burden impeding study participation\n* Being in psychotherapy"}, 'identificationModule': {'nctId': 'NCT02051660', 'briefTitle': 'German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)', 'orgStudyIdInfo': {'id': 'DKH-110746'}, 'secondaryIdInfos': [{'id': 'DKH-109967', 'type': 'OTHER_GRANT', 'domain': 'German Cancer Aid'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manualized CALM Intervention', 'interventionNames': ['Behavioral: Manualized CALM intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-manualized supportive intervention', 'interventionNames': ['Behavioral: Non-manualized supportive intervention.']}], 'interventions': [{'name': 'Manualized CALM intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Managing Cancer and Living Meaning Cancer (CALM)'], 'description': 'Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.', 'armGroupLabels': ['Manualized CALM Intervention']}, {'name': 'Non-manualized supportive intervention.', 'type': 'BEHAVIORAL', 'description': 'Supportive psycho-oncological intervention.', 'armGroupLabels': ['Non-manualized supportive intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Anja Mehnert, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center of Leipzig'}, {'name': 'Martin Härter, Prof Dr Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Aid', 'class': 'OTHER'}, {'name': 'University of Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Anja Mehnert', 'investigatorFullName': 'Anja Mehnert', 'investigatorAffiliation': 'University of Leipzig'}}}}