Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2026-01-06 @ 12:36 AM
Study NCT ID:
NCT00234793
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Problem-Solving in Childhood Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 433}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2010-04'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity'}, {'measure': 'e.g. depression, anxiety, and increasing satisfaction with resource utilization'}], 'secondaryOutcomes': [{'measure': 'Standardized measures at three time points: pre-intervention, post-intervention, 3 months post the second time point'}]}, 'conditionsModule': {'keywords': ['childhood cancer', 'intervention', 'maternal coping', 'problem solving skills', 'anxiety', 'cope', 'problem solving'], 'conditions': ['Stress', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '19091804', 'type': 'RESULT', 'citation': 'Askins MA, Sahler OJ, Sherman SA, Fairclough DL, Butler RW, Katz ER, Dolgin MJ, Varni JW, Noll RB, Phipps S. Report from a multi-institutional randomized clinical trial examining computer-assisted problem-solving skills training for English- and Spanish-speaking mothers of children with newly diagnosed cancer. J Pediatr Psychol. 2009 Jun;34(5):551-63. doi: 10.1093/jpepsy/jsn124. Epub 2008 Dec 17.'}, {'pmid': '23358975', 'type': 'DERIVED', 'citation': 'Sahler OJ, Dolgin MJ, Phipps S, Fairclough DL, Askins MA, Katz ER, Noll RB, Butler RW. Specificity of problem-solving skills training in mothers of children newly diagnosed with cancer: results of a multisite randomized clinical trial. J Clin Oncol. 2013 Apr 1;31(10):1329-35. doi: 10.1200/JCO.2011.39.1870. Epub 2013 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.', 'detailedDescription': 'The purpose of this study is:\n\n1. to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo);\n2. to develop a personal digital assistant hand-held supplement to standard PSST to provide real-time training, reinforcement, and on-the-spot documentation of PSST usage;\n3. to develop independent measures of the application of problem-solving strategies in everyday life; and\n4. to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of PSST.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact.\n\nExclusion Criteria:\n\n* Mothers of children with cancer if they do not read or speak English or Spanish, if their child is in severe medical crisis, or if they live a prohibitive distance to complete the intervention.'}, 'identificationModule': {'nctId': 'NCT00234793', 'briefTitle': 'Maternal Problem-Solving in Childhood Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Maternal Problem-Solving in Childhood Cancer', 'orgStudyIdInfo': {'id': 'RO1 CA098964-02'}, 'secondaryIdInfos': [{'id': 'RSRB 09840'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Problem-Solving Skills Training', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027-6016', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15214', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT/MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Olle Jane Z. Sahler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Robert W Butler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Martha A Askins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}, {'name': 'Robert B Noll, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Ernest R Katz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}, {'name': 'Donna R Copeland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT/MD Anderson Cancer Center'}, {'name': 'Lewis W Johnson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'OJ Sahler', 'investigatorAffiliation': 'University of Rochester'}}}}