Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-26 @ 3:16 AM
Study NCT ID:
NCT01901835
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument', 'timeFrame': 'Up to day 1 of course 3 of chemotherapy', 'description': 'Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in PANAS-X positive and negative affect scores between groups.'}], 'secondaryOutcomes': [{'measure': 'Humor Styles Questionnaire (HSQ) total score', 'timeFrame': 'Up to day 1 of course 3 of chemotherapy', 'description': 'Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in HSQ total scores between groups.'}, {'measure': 'Brief Fatigue Inventory (BFI) total score', 'timeFrame': 'Up to day 1 of course 3 of chemotherapy', 'description': 'Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in BFI total scores between groups.'}, {'measure': 'Ease of use (EoS) score', 'timeFrame': 'Up to day 1 of course 3 of chemotherapy', 'description': "Assessed with a Likert scale at the completion of the subject's participation to understand how the intervention may be improved should results of this study favor implementation into standard clinical procedure for future patients. Summarized in terms of medians and ranges, stratified by group and assessment time point. Changes from baseline within each group will be evaluated using a nonparametric Wilcoxon Signed Rank test"}, {'measure': 'Quality of materials (QOM) score', 'timeFrame': 'Up to day 1 of course 3 of chemotherapy', 'description': "Assessed with a Likert scale at the completion of the subject's participation to understand how the intervention may be improved should results of this study favor implementation into standard clinical procedure for future patients. Summarized in terms of medians and ranges, stratified by group and assessment time point. Changes from baseline within each group will be evaluated using a nonparametric Wilcoxon Signed Rank test"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Female Reproductive Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies media diversion in improving quality of life in patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may improve mood and quality of life in patients having cancer treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To analyze the impact of a media-based intervention on patient mood during the receipt of chemotherapy for recurrent gynecologic cancers.\n\nOUTLINE: are randomized to 1 of 2 arms.\n\nARM I: Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.\n\nARM II: Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with pathologically-proven gynecologic malignancies\n* Subjects who have previously completed primary treatment for a gynecologic malignancy\n* Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)\n* Patients must be English speaking\n* Patients must have the ability to use audio media and read and understand written English\n\nExclusion Criteria:\n\n* Patients unable to use audio or video media due to auditory or ocular dysfunction\n* Patients unable to read written English\n* Patients who are prisoners or incarcerated'}, 'identificationModule': {'nctId': 'NCT01901835', 'briefTitle': 'Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers', 'orgStudyIdInfo': {'id': 'UW13037'}, 'secondaryIdInfos': [{'id': 'NCI-2013-01284', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': '2013-0618', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'P30CA014520', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014520', 'type': 'NIH'}, {'id': 'A532820', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/OBSTET & GYNECOL/', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (humorous followed by non-humorous movies)', 'description': 'Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.', 'interventionNames': ['Procedure: mind-body intervention procedure', 'Other: survey administration', 'Procedure: quality-of-life assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (non-humorous followed by humorous movies)', 'description': 'Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.', 'interventionNames': ['Procedure: mind-body intervention procedure', 'Other: survey administration', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'mind-body intervention procedure', 'type': 'PROCEDURE', 'otherNames': ['mind-body interventions'], 'description': 'Participate in media diversion with humorous and non-humorous movies', 'armGroupLabels': ['Arm I (humorous followed by non-humorous movies)', 'Arm II (non-humorous followed by humorous movies)']}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (humorous followed by non-humorous movies)', 'Arm II (non-humorous followed by humorous movies)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (humorous followed by non-humorous movies)', 'Arm II (non-humorous followed by humorous movies)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Stephen Rose', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}