Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-11 @ 4:05 AM
Study NCT ID:
NCT03612050
Status:
UNKNOWN
Last Update Posted:
2021-08-30
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meaning Centered Psychotherapy for Palliative Care Patients (MCP-PC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spiritual Well Being', 'timeFrame': 'Through study completion (approx 6 weeks)', 'description': 'Overall spiritual well-being as measured through the self-report FACIT Spiritual Well Being scale'}], 'secondaryOutcomes': [{'measure': 'Hopelessness', 'timeFrame': 'Through study completion (approx 6 weeks)', 'description': 'Self-report rating scale, the Hopelessness Assessment in Illness scale'}, {'measure': 'Acceptance of Death', 'timeFrame': 'Through study completion (approx 6 weeks)', 'description': 'Subscale derived from the Life Attitude Profile, a self-report measure of meaning and purpose'}, {'measure': 'Health related Quality of life', 'timeFrame': 'Through study completion (approx 6 weeks)', 'description': 'Single item rating of overall quality of life derived from the McGill Quality of Life Questionnaire'}, {'measure': 'Desire for hastened death', 'timeFrame': 'Through study completion (approx 6 weeks)', 'description': 'Abbreviated version of the Schedule of Attitudes towards Hastened Death, a measure of desire for hastened death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative care', 'Despair', 'Spiritual well-being'], 'conditions': ['Palliative Care']}, 'referencesModule': {'references': [{'pmid': '27435603', 'type': 'BACKGROUND', 'citation': 'Rosenfeld B, Saracino R, Tobias K, Masterson M, Pessin H, Applebaum A, Brescia R, Breitbart W. Adapting Meaning-Centered Psychotherapy for the palliative care setting: Results of a pilot study. Palliat Med. 2017 Feb;31(2):140-146. doi: 10.1177/0269216316651570. Epub 2016 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, controlled trial evaluates the effectiveness of an adaptation of a well-established brief, structured existential psychotherapy (Meaning Centered Psychotherapy) specifically tailored to the needs of palliative care patients (MCP-PC). Terminally ill patients with cancer who have been hospitalized in a palliative care hospital will be randomly assigned to either MCP-PC or enhanced usual care. Patients will complete a very short battery of self-report measures before the 3-session intervention, and again 2 and 4 weeks later to determine whether treatment has bolstered spiritual and psychological well-being and improved quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Terminal illness with life expectancy of less than 6 months; hospitalized at a palliative care facility in Bronx NY, English speaking\n\nExclusion Criteria:\n\n* Cognitive impairment or severe psychiatric symptoms that preclude informed consent or participation in treatment.'}, 'identificationModule': {'nctId': 'NCT03612050', 'acronym': 'MCP-PC', 'briefTitle': 'Meaning Centered Psychotherapy for Palliative Care Patients (MCP-PC)', 'organization': {'class': 'OTHER', 'fullName': 'Fordham University'}, 'officialTitle': 'Development of Meaning Centered Psychotherapy for Palliative Care Patients', 'orgStudyIdInfo': {'id': 'R21 NR017728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'facilitate any clinical interventions', 'interventionNames': ['Behavioral: Meaning Centered Psychotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Meaning Centered Psychotherapy', 'description': "raise patients' sense of meaning/purpose", 'interventionNames': ['Behavioral: Meaning Centered Psychotherapy']}], 'interventions': [{'name': 'Meaning Centered Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Manualized, 3-session existential psychotherapy (30-45 minutes/session) with an optional 4th "booster" session. Content focuses on enhancing patients sense of meaning and purpose in life.', 'armGroupLabels': ['Enhanced Usual Care', 'Meaning Centered Psychotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Barry D Rosenfeld, PhD', 'role': 'CONTACT', 'email': 'rosenfeld@fordham.edu', 'phone': '718-817-3794'}], 'overallOfficials': [{'name': 'Barry Rosenfeld, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fordham University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'One year after completion of data collection.', 'ipdSharing': 'YES', 'description': 'Data will be made available upon request following completion of the study.', 'accessCriteria': 'Affiliation with medical or university-based research institute'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fordham University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Calvary Hospital, Bronx, NY', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}