Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-25 @ 10:43 AM
Study NCT ID:
NCT06374251
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who complete the narrative medicine sessions', 'timeFrame': 'Up to 3 months', 'description': 'To determine the intervention feasibility, the number of participants who complete the narrative medicine sessions will be tracked.'}, {'measure': 'Change in well-being scores', 'timeFrame': 'Up to 3 months', 'description': 'Will be evaluated using the Edmonton Symptom Assessment System-Revised Version (ESAS-r). The total score ranges from 0 to 10, with a higher score indicating worse outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Digestive System Neoplasm']}, 'descriptionModule': {'briefSummary': "This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the feasibility of implementing narrative medicine tools in serial workshops with patients with malignancy.\n\nII. To determine if narrative medicine interventions improve markers and expressions of well-being.\n\nDESCRIPTIVE OBJECTIVES:\n\nI. To estimate changes in markers and expressions of well-being after 3 sessions of narrative medicine intervention.\n\nII. To determine, through qualitative methods, if patients find benefit from the intervention regarding their well-being.\n\nIII. To decide whether to expand these kinds of interventions to a larger study with control group.\n\nOUTLINE:\n\nPatients participate in narrative medicine sessions over 60 minutes once every 2 weeks (Q2W) for 3 sessions.\n\nAfter completion of study intervention, patients are followed up at 1 and 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of gastrointestinal malignancy actively receiving infusional therapy for cancer.\n* Age \\>= 18 years.\n* English speaking with ability to participate in reading and writing questionnaires and implementation tools.\n* Performance Status =\\< Eastern Cooperative Oncology Group (ECOG) 3.\n\nExclusion Criteria:\n\n* Altered mental status or other cognitive impairment, organic or drug induced that would limit ability to participate in the evaluation.'}, 'identificationModule': {'nctId': 'NCT06374251', 'briefTitle': 'Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Can Narrative Medicine Methods Improve Well-Being in Patients With GI Malignancies', 'orgStudyIdInfo': {'id': '0S-23-2'}, 'secondaryIdInfos': [{'id': 'NCI-2023-08890', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '0S-23-2', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (narrative medicine sessions)', 'description': 'Patients participate in narrative medicine sessions over 60 minutes Q2W for 3 sessions.', 'interventionNames': ['Procedure: Discussion', 'Other: Interview', 'Other: Survey Administration']}], 'interventions': [{'name': 'Discussion', 'type': 'PROCEDURE', 'otherNames': ['Discuss'], 'description': 'Participate in narrative medicine sessions', 'armGroupLabels': ['Supportive Care (narrative medicine sessions)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (narrative medicine sessions)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (narrative medicine sessions)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Eve L Makoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}