Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-27 @ 5:12 AM
Study NCT ID:
NCT03067766
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2017-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comic Art Creation as Supportive Care in Cancer Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001155', 'term': 'Art Therapy'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-02-24', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the comic art creation workshop defined as participant completion and psychosocial value of the comic art', 'timeFrame': 'Up to 1.5 years', 'description': 'The project will be considered feasible if most of the participants complete the study and consider the comic art to have personal meaning, and if an initial power calculation indicates that a sufficiently powered randomized controlled trial is possible given the resources of the study team. It is anticipated that the psychosocial value of the art will be largely derived from the internal creation process and further assessment of the artistic products will not be conducted.'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale questionnaire', 'timeFrame': 'Baseline to up to 6 weeks post-workshop', 'description': 'Statistical analysis will include Wilcoxon signed ranks test of pre, mid and post workshop HRQOL and symptom assessments. The Friedman test will be used to measure magnitude of difference within a case.'}, {'measure': 'Change in health-related quality of life (HRQOL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30', 'timeFrame': 'Baseline to up to 6 weeks post-workshop', 'description': 'Statistical analysis will include Wilcoxon signed ranks test of pre, mid and post workshop HRQOL and symptom assessments. The Friedman test will be used to measure magnitude of difference within a case.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver', 'Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well comic art creation works as supportive care in cancer patients and caregivers. Participating in a comic art creation workshop may help patients and their family members or friends share their medical experience through storytelling and drawings in a way that can, but does not have to, reflect the real world. It may also help improve emotional wellbeing and communication in cancer patients and caregivers.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the feasibility of using a 10 week (Workshop A) or a 5 week (Workshops B-C) comic art creation workshops for supportive care.\n\nII. To determine the feasibility of studying comic art creation workshops for supportive care.\n\nIII. To describe those factors affecting the ability or inability of participants to engage in the workshop.\n\nSECONDARY OBJECTIVES:\n\nI. To describe changes in emotional wellbeing and communication of patients and caretakers/family/friends.\n\nTERTIARY OBJECTIVES:\n\nI. Identify the methods that most engage supportive care patients and caretakers.\n\nII. Identify the social and cultural interactions most impacted by comics creation.\n\nIII. To describe participant feedback regarding the intervention and study design.\n\nOUTLINE: Patients are assigned to 1 of 2 arms.\n\nWORKSHOP A: Patients and a family member, caretaker, or friend participate in an artist-led comic art therapy workshop over 2 hours once a week for 10 weeks. Patients and participants receive a range of assignments that focus on creative art and experimentation with materials and storytelling in order to make a series of small handmade books that relate directly or indirectly to their experience with cancer. Patients undergo a qualitative interview over approximately 45 minutes and complete validated questionnaires within 4 weeks prior to the workshop and midway through the workshop.\n\nWORKSHOPS B AND C: Patients participate in an artist-led comic art therapy workshop over 3 hours once a week for 5 weeks. Patients receive a range of assignments that focus on creative art and experimentation with materials and storytelling in order to make a series of small handmade books that relate directly or indirectly to their experience with cancer. Patients undergo a qualitative interview over approximately 45 minutes and complete validated questionnaires within 4 weeks prior to the workshop.\n\nAfter completion of the study, patients are followed up at 1 and 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented written informed consent of the participant\n* Workshop A (2017 - 10 weeks- City of Hope)\n\n * Either one of the following:\n * City of Hope (COH) cancer patient (all types and at any time point of their disease) OR\n * Caretaker/friend family member of the cancer patient\n* Workshops B and C (2018 - 5 weeks - City of Hope)\n\n * Cancer patients (all types and at any time point in their disease)\n * Note: documentation to confirm this eligibility criteria will not be requested; self-reporting as a cancer patient will be considered adequate\n* Ability read and speak English\n* Willingness and ability to complete the entire workshop, including the interviews and questionnaires (there is no predetermined qualification with regard to the ability to hold an artist tool; accommodations and creative solutions will be made to facilitate participation)'}, 'identificationModule': {'nctId': 'NCT03067766', 'briefTitle': 'Comic Art Creation as Supportive Care in Cancer Patients and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'A Pilot Study to Test the Feasibility of Comic Art Creation for Symptom Management in Cancer Supportive Care', 'orgStudyIdInfo': {'id': '16251'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00287', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '16251', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Workshop A (10 weeks - comic art creation workshop)', 'description': 'Patients and a family member, caretaker, or friend participate in an artist-led comic art therapy workshop over 2 hours once a week for 10 weeks. Patients and participants receive a range of assignments that focus on creative art and experimentation with materials and storytelling in order to make a series of small handmade books that relate directly or indirectly to their experience with cancer. Patients undergo a qualitative interview over approximately 45 minutes and complete validated questionnaires within 4 weeks prior to the workshop and midway through the workshop.', 'interventionNames': ['Procedure: Art Therapy', 'Other: Interview', 'Procedure: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Workshop B and C (5 weeks - comic art creation workshop)', 'description': 'Patients participate in an artist-led comic art therapy workshop over 3 hours once a week for 5 weeks. Patients receive a range of assignments that focus on creative art and experimentation with materials and storytelling in order to make a series of small handmade books that relate directly or indirectly to their experience with cancer. Patients undergo a qualitative interview over approximately 45 minutes and complete validated questionnaires within 4 weeks prior to the workshop.', 'interventionNames': ['Procedure: Art Therapy', 'Other: Interview', 'Procedure: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Art Therapy', 'type': 'PROCEDURE', 'description': 'Participate in a comic art creation workshop', 'armGroupLabels': ['Workshop A (10 weeks - comic art creation workshop)', 'Workshop B and C (5 weeks - comic art creation workshop)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Undergo qualitative interviews', 'armGroupLabels': ['Workshop A (10 weeks - comic art creation workshop)', 'Workshop B and C (5 weeks - comic art creation workshop)']}, {'name': 'Quality-of-Life Assessment', 'type': 'PROCEDURE', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Workshop A (10 weeks - comic art creation workshop)', 'Workshop B and C (5 weeks - comic art creation workshop)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Workshop A (10 weeks - comic art creation workshop)', 'Workshop B and C (5 weeks - comic art creation workshop)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Jaroslava Salman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}