Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06307535
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with improved primary outcomes', 'timeFrame': 'Up to 1 year', 'description': 'Evaluate the efficacy of MCP-C versus SP-C in improving primary outcomes (i.e., sense of meaning in life, spiritual well-being) immediately post-treatment and explore maintenance in gains up to 1 year.'}, {'measure': 'Life Attitude Profile-Revised (LAP-R)', 'timeFrame': 'Up to 1 year', 'description': 'Life Attitude Profile-Revised (LAP-R) - used to measure sense of meaning in life.\n\nThe LAP-R is a 48-item instrument. Each item is rated on a 7-point Likert scale ranging from "strongly agree" to "strongly disagree." Full scale ranges from 30 to 210 with a higher score indicating a greater sense of meaning in life and a more positive attitude towards life.'}, {'measure': 'FACIT Spiritual Well-Being Scale (SWBS)', 'timeFrame': 'Up to 1 year', 'description': 'The Spiritual Well-Being Scale (SWBS) - used to measure spiritual well-being.\n\nThe SWBS is a 12-item instrument. Each item is scored from 1 to 5. Negatively worded items are reverse scored. The measure generates two sub-scales: Faith/Spirituality (0-16) and Meaning/Peace (0-32). Full scale ranges from 0 to 48. Higher scores indicate a greater sense of spiritual well-being.'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Up to 1 year', 'description': 'Hospital Anxiety and Depression Scale (HADS) - measures anxiety and depression.\n\n14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating poorer health outcome.'}, {'measure': 'Benefit Finding Scale (BFS)', 'timeFrame': 'Up to 1 year', 'description': 'Benefit Finding Scale (BFS) - measures benefit finding.\n\nThe BFS is a 17-item instrument. Each item is scored from 1-5 (not at all, a little bit, somewhat, quite a bit, or very much). Full scale ranges from 17 to 85, with higher scores indicating greater benefit finding.'}, {'measure': 'Caregiver Reaction Assessment (CRA)', 'timeFrame': 'Up to 1 year', 'description': 'Caregiver Reaction Assessment (CRA) - measures caregiver burden.\n\nThe CRA is a 24-item instrument. Full scale ranges from 24 to 120, with higher scores indicating greater caregiving burden'}, {'measure': 'Duke-UNC Functional Social Support Questionnaire (FSSQ)', 'timeFrame': 'Up to 1 year', 'description': 'Duke-UNC Functional Social Support Questionnaire (FSSQ) - measures social support.\n\nThe FSSQ is an 8-item instrument. Each item is scored on a scale of 5-1 where 5=as much as I would like; 4=almost as much as I would like; 3=some, but would like more; 2=less than i would like, and 1=much less than I would like. Full scale ranges from 0 to 44 with higher scores indicating a higher degree of satisfaction related to social support.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregiver', 'Caregiver Stress Syndrome', 'Caregiver Burden', 'Caregiver Burnout', 'Meaning-Centered Psychotherapy', '23-376'], 'conditions': ['Caregiver Burden', 'Caregiver Burnout', 'Caregiver Stress Syndrome']}, 'descriptionModule': {'briefSummary': "Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.\n\nAfter participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.\n\nParticipants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or over;\n* As per self-report, a current caregiver to a patient with Stage III or IV solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative);\n* Experiences distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and an indication that this distress is associated with caregiving;\n* As per self-report, can read and understand English;\n* As per self-report, residing in New York, New Jersey, or Florida, or have the ability to complete sessions while complying with current telehealth regulations.\n\nExclusion Criteria:\n\n* Participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional;\n* Engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.'}, 'identificationModule': {'nctId': 'NCT06307535', 'briefTitle': 'A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Meaning-Centered Psychotherapy to Meet Palliative Care Needs of Cancer Caregivers', 'orgStudyIdInfo': {'id': 'STUDY-24-01356'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meaning-Centered Psychotherapy for Caregivers', 'description': 'Meaning-Centered Psychotherapy for Caregivers/MCP-C', 'interventionNames': ['Behavioral: Meaning-Centered Psychotherapy for Caregivers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Psychotherapy for Caregivers', 'description': 'Supportive Psychotherapy for Caregivers/SP-C standard of care', 'interventionNames': ['Behavioral: Supportive Psychotherapy for Caregivers']}], 'interventions': [{'name': 'Meaning-Centered Psychotherapy for Caregivers', 'type': 'BEHAVIORAL', 'otherNames': ['MCP-C'], 'description': 'MCP-C is a stakeholder-informed, innovative, manualized intervention designed to assist caregivers to connect to a sense of meaning and purpose in life, despite the challenges of caregiving.', 'armGroupLabels': ['Meaning-Centered Psychotherapy for Caregivers']}, {'name': 'Supportive Psychotherapy for Caregivers', 'type': 'BEHAVIORAL', 'otherNames': ['SP-C'], 'description': 'Standard of care supportive psychotherapy', 'armGroupLabels': ['Supportive Psychotherapy for Caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendy Lichtenthal, PhD', 'role': 'CONTACT', 'phone': '305-243-8983'}], 'facility': 'University of Miami (Data Collection AND Data Analysis)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Monmouth (Limited protocol activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Talia Zaider, PhD', 'role': 'CONTACT', 'email': 'zaidert@mskcc.org', 'phone': '646-888-0162'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activites)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Allison Applebaum, PhD, FAPOS', 'role': 'CONTACT', 'email': 'allison.applebaum@mssm.edu', 'phone': '212-241-8561'}, {'name': 'Morgan Loschiavo, MPH', 'role': 'CONTACT', 'email': 'LoschiaM@mskcc.org', 'phone': '646-888-0225'}], 'overallOfficials': [{'name': 'Allison Applebaum, PhD, FAPOS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'url': 'https://ip.mountsinai.org/contact-msip/', 'timeFrame': 'Until six years post publication', 'ipdSharing': 'YES', 'description': 'Requests for deidentified individual participant data can be made from the date of publication until six years post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: MSIPinfo@mssm.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'University of Miami Sylvester Comprehensive Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Allison Applebaum', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}