Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-29 @ 2:18 AM
Study NCT ID:
NCT06367959
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2024-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Benefits of Writing Therapy Among Asian American Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'Time Frame: through study completion; an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health.", 'detailedDescription': 'Primary Objective:\n\nTo determine the effects of writing therapy on QOL and perceived stress at the 6- and 12-month follow-ups.\n\nSecondary Objective:\n\nTo discover the effects of writing therapy on stress biomarkers and perceived stress at the 3-month follow-up.\n\nTo explore the psychosocial and cultural mechanisms responsible for the benefits of writing therapy by using mixed methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (aged 18 and older) diagnosed with stage 0-III cancer (or acute leukemia in remission/ chronic myeloid leukemia in chronic phase).\n* Self-identified as Asian, Asian Americans, any Asian or Asian American subgroup (Chinese, Vietnamese, Indian, Korean, etc.) ethnic/cultural background\n* Completed primary treatment, including surgery, chemotherapy, and/or radiation therapy, immunotherapy, or targeted therapy within the preceding 5 years.\n* Comfortable reading in English or in Chinese.\n\nExclusion Criteria:\n\n\\- Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06367959', 'briefTitle': 'Health Benefits of Writing Therapy Among Asian American Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Health Benefits of Writing Therapy Among Asian American Cancer Survivors', 'orgStudyIdInfo': {'id': '2021-0324'}, 'secondaryIdInfos': [{'id': 'NCI-2024-02939', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control condition', 'description': 'Participants will be asked to write about facts regarding their cancer diagnosis and treatment in writing sessions.', 'interventionNames': ['Behavioral: Esays', 'Behavioral: Questionnaires']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Condition', 'description': 'Participants will be asked to write about different topics regarding their cancer experience. During session 1, participants will be asked to write about the stress of having cancer and their strategies for coping with stressors associated with their cancer (i.e., stress and coping). During session 2, participants will be asked to write about their deepest feelings regarding their cancer experience (i.e., emotional disclosure). During session 3 and the booster session (at 9-month follow-up), participants will be asked to write about positive thoughts and feelings regarding their experience with cancer.', 'interventionNames': ['Behavioral: Esays', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Esays', 'type': 'BEHAVIORAL', 'description': 'Participants will write about their experiences One (1) time each week for 3 weeks at the beginning of the study and then 1 more time 9 months later. Participants will be asked to write about their experiences with cancer in English or Chinese and to write as much as they can for about 20-30 minutes for each essay.', 'armGroupLabels': ['Control condition', 'Intervention Condition']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Participants will answer a questionnaire at the beginning of the study and then 3, 6, and 12 months later.\n\nParticipants will also answer a questionnaire about their thoughts on writing and on the study after they complete the third essay.', 'armGroupLabels': ['Control condition', 'Intervention Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Qian Lu, MD, PHD', 'role': 'CONTACT', 'email': 'qlu@mdanderson.org', 'phone': '713-745-8324'}, {'name': 'Qian Lu, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Qian Lu, MD, PHD', 'role': 'CONTACT', 'email': 'qlu@mdanderson.org', 'phone': '(713) 745-8324'}], 'overallOfficials': [{'name': 'Qian Lu, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}