Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT06293456
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patients who complete the intervention', 'timeFrame': '1 year', 'description': 'This requires meeting both of the following criteria: i) collection of the DT Interview for 30 patients; and ii) delivery of the poem to at least 22 (\\>75%) participants.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dignity Therapy (DT)', 'End of Life (EOL)'], 'conditions': ['End of Life']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender minority (SGM) patients in MSK. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* SGM (as per self-report) palliative care patients identified through Memorial Sloan Kettering Cancer Center's Palliative Care team and primary solid tumor oncology clinics.\n* Age 18 and older (as per self-report/EHR)\n* English-speaking as per the English language assessment items below and wil ing to receive the intervention in English.\n\n o What is the participant's preferred language?\n* (Specify Lang)\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\n * How well does the participant speak English?\n * Very well (PARTICIPANT IS ELIGIBLE)\n * Well (PARTICIPANT is ELIGIBLE)\n * Not well (PARTICIPANT is NOT ELIGIBLE)\n * Not at all (PARTICIPANT is NOT ELIGIBLE)\n\nExclusion Criteria:\n\n* Delirium/ altered mental status prohibitive of providing consent."}, 'identificationModule': {'nctId': 'NCT06293456', 'briefTitle': 'Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'An Open Trial of a Novel Poetic Dignity Therapy Intervention to Enhance Meaning and Purpose for Sexual and Gender Minority Patients With Cancer', 'orgStudyIdInfo': {'id': '23-360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dignity Therapy', 'description': 'The DT intervention is a 45-75-minute virtual interview, which is recorded and transcribed within 1-2 weeks of the interview.', 'interventionNames': ['Other: Dignity Therapy']}], 'interventions': [{'name': 'Dignity Therapy', 'type': 'OTHER', 'description': 'A trained research staff member will conduct the DT interview virtually. The interview will occur or by phone only if the participant lacks access to technology for videoconferencing. The interviewer asks a series of open-ended questions that encourages patients to talk about their lives and what matters most to them.', 'armGroupLabels': ['Dignity Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth (Consent Only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen (Consent Only)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Suffolk- Commack (Consent Only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau (Consent Only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'overallOfficials': [{'name': 'William E Rosa, Ph.D., MBE, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months 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: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}