Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT01037933
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2009-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comedy in Chemotherapy (COMIC) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-22', 'studyFirstSubmitDate': '2009-12-21', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention', 'timeFrame': 'One day'}], 'secondaryOutcomes': [{'measure': 'To compare changes in a marker of immune function (salivary immunoglobulin A), and a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD.', 'timeFrame': 'One day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Humor', 'Distraction', 'Comedy', 'Chemotherapy'], 'conditions': ['Cancer', 'Chemotherapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://queens.org', 'label': "The Queen's Medical Center"}]}, 'descriptionModule': {'briefSummary': 'Primary aims: To compare changes in (a) symptoms related to cancer and chemotherapy, (b) a marker of immune function (salivary immunoglobulin A), and (c) a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD.\n\nSecondary aim: To describe the perception of patients, caregivers, and nurses regarding the overall intervention experience.', 'detailedDescription': 'Patients were recruited from the Outpatient Oncology (OPO) clinic at QMC. After signing an informed consent, patients receiving intravenous chemotherapy were randomly assigned to view a 45-minute humorous DVD or non-humorous DVD. The following measurements were obtained before and after patients viewed the DVD: Edmonton Symptom Assessment Scale (ESAS) and the state portion of the Spielberger State-Trait Anxiety Index (STAI-S) to assess symptoms related to cancer and chemotherapy, salivary immunoglobulin A (IgA) to assess immune function and salivary cortisol to assess emotional stress. In addition, patients, caregivers, and nurses were asked open-ended questions after the intervention to ascertain their impression of the overall intervention experience. Multiple analysis of covariance (MANCOVA) were be used to analyze changes in ESAS, STAI-S, IgA and cortisol within and between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of cancer\n2. Receiving intravenous chemotherapy in the OPO clinic at QMC\n3. Has a minimum appointment time in OPO of two hours\n4. Age 21 or older\n5. Speaks English\n\nExclusion Criteria:\n\n1. Blind\n2. Deaf\n3. Diagnosis of head/neck cancer\n4. Severe oral mucositis\n5. Cognitively impaired\n\n \\-'}, 'identificationModule': {'nctId': 'NCT01037933', 'acronym': 'COMIC', 'briefTitle': 'Comedy in Chemotherapy (COMIC) Study', 'organization': {'class': 'OTHER', 'fullName': "Queen's Medical Center"}, 'officialTitle': 'Comedy in Chemotherapy (COMIC) Study', 'orgStudyIdInfo': {'id': 'RA2007020'}, 'secondaryIdInfos': [{'id': 'Hob Osterlund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Humor intervention', 'description': 'A 45-minute humorous DVD ("Bananas Bunch") using a portable DVD player.', 'interventionNames': ['Other: Humor intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-humor intervention', 'description': 'A 45-minute non-humorous DVD "The A to Z of Steam Railways" using a portable DVD player.', 'interventionNames': ['Other: Non-humor intervention (distraction)']}], 'interventions': [{'name': 'Humor intervention', 'type': 'OTHER', 'description': 'A 45-minute humorous DVD ("Bananas Bunch") using a portable DVD player.', 'armGroupLabels': ['Humor intervention']}, {'name': 'Non-humor intervention (distraction)', 'type': 'OTHER', 'description': 'A 45-minute non-humorous DVD ("The A to Z of Steam Railways") using a portable DVD player', 'armGroupLabels': ['Non-humor intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "The Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Hob Osterlund, RN, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Queen's Medical Center"}, {'name': 'Brad Willcox, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "The Queen's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's Medical Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Emma Nursing Research Institute', 'class': 'UNKNOWN'}, {'name': 'University of Hawaii', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Hob Osterlund, APRN Clinical Nurse Specialist, Pain and Palliative Care Department', 'oldOrganization': "The Queen's Medical Center"}}}}