Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-29 @ 2:03 AM
Study NCT ID:
NCT05975333
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Writing Intervention With Adolescents and Young Adults With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007839', 'term': 'Functional Laterality'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D004292', 'term': 'Dominance, Cerebral'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-27', 'size': 260681, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-27T14:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of touchpoints that participants have with the narrative medicine expert/guide', 'timeFrame': 'During the narrative exercise, up to 2 months after enrollment', 'description': 'To determine intervention feasibility, the number of touchpoints that participants have with the narrative medicine expert/guide will be tracked'}, {'measure': 'Number of participants who complete the writing exercise', 'timeFrame': 'During the narrative exercise, up to 2 months after enrollment', 'description': 'To determine intervention feasibility, the number of participants who complete the writing exercise will be tracked'}, {'measure': 'Intervention acceptability', 'timeFrame': 'Post-intervention interview will occur after the narrative exercise is completed at around 2 months after enrollment, +/- 1 month', 'description': 'Comparison of acceptability between participants who did/did not participate in the optional check-ins. Analysis of de-identified semi-structured interviews will be done. Interviews will be recorded, transcribed, de-identified, and analyzed using content analysis, an inductive approach that includes memo-writing, codebook development, coding, reconciliation, and synthesis to identify emerging patterns and themes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescents', 'Young Adults', 'Writing Intervention', 'Interview'], 'conditions': ['Cancer Patients', 'Communication Research']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': "Young people with cancer have difficult experiences and writing exercises may help improve their well-being. However, very few studies have examined how a creative writing activity might be useful for young people with cancer. In this pilot study, researchers at St. Jude Children's Research Hospital hope to explore whether teenagers and young adults with cancer want to participate in a writing exercise and whether they find it to be valuable.\n\nPrimary Objective\n\nTo assess the feasibility and acceptability of a writing-based narrative medicine intervention for adolescent and young adult patients with cancer.", 'detailedDescription': 'Participants will be given the opportunity to write about their experiences with cancer, with support and guidance from an expert writer. Participants will meet briefly with the expert at the start of the exercise (15-30 minutes), and they can choose to meet 1-3 additional times with the expert over the next 2 months to receive further support if they wish.\n\nAfter completing the writing exercise, participants will do an informal interview to share their thoughts about whether the experience of writing felt helpful or not. The post-intervention interview will occur at around 2 months after enrollment, +/- 1 month. Patients may participate in a second informal semi-structured interview 6 to 12 months after completing the first interview. Additionally, bereaved parents may participate in an informal interview on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 15-25\n* Currently receiving cancer-directed therapy\n* Active patient at St. Jude Children's Research Hospital\n* Parent of a ChronCan participant who has passed away\n\nExclusion Criteria:\n\n* Does not meet the inclusion criteria\n* If the parents have not responded or not interviewed till December 31, 2025."}, 'identificationModule': {'nctId': 'NCT05975333', 'briefTitle': 'Writing Intervention With Adolescents and Young Adults With Cancer', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'ChronCan (Chronicling Cancer): Piloting a Novel Writing Intervention With Adolescents and Young Adults With Cancer', 'orgStudyIdInfo': {'id': 'ChronCan'}, 'secondaryIdInfos': [{'id': 'NCI-2023-06074', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'description': "Adolescents and young adults (AYA) patients aged 15-25 years currently receiving cancer-directed therapy at St. Jude Children's Research Hospital", 'interventionNames': ['Behavioral: Writing', 'Behavioral: Interview']}], 'interventions': [{'name': 'Writing', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to write about their experiences with cancer, guided by several specific open-ended writing prompts to spark ideas.', 'armGroupLabels': ['Participants']}, {'name': 'Interview', 'type': 'BEHAVIORAL', 'otherNames': ['Questions'], 'description': 'Following completion of the writing exercise, participants will reflect on their experiences with the writing intervention in a semi-structured private interview with a member of the research team.', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erica Kaye, MD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}, {'name': 'Erica Kaye, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Erica Kaye, MD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}], 'overallOfficials': [{'name': 'Erica Kaye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be made available at the time of article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.', 'accessCriteria': 'Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}