Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-28 @ 8:50 PM
Study NCT ID:
NCT00468468
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2007-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mentor Integration Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2007-04-30', 'studyFirstSubmitQcDate': '2007-05-01', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient quality of life', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'Self efficacy', 'timeFrame': 'throughout study'}, {'measure': 'Emotional well being', 'timeFrame': 'throughout study'}]}, 'conditionsModule': {'keywords': ['breast cancer', 'Internet', 'computer', 'support', 'information', 'education'], 'conditions': ['CHESS and Cancer Mentor', 'CHESS Only', 'Mentor Only', 'Control (Internet Only)']}, 'descriptionModule': {'briefSummary': 'Mentor Integration Project\n\nThis study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.\n\nPrimary Aims:\n\n* Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer\n* Determine which of the above conditions is most effective\n* Determine which of the above conditions is most cost efficient'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligibility for this protocol is as follows:\n\n* All subjects must be within 2 months of their primary breast cancer diagnosis,\n* All subjects must be at least 18 years of age,\n* All subjects must be able to read and write English at the 6th-grade level\n* Not homeless'}, 'identificationModule': {'nctId': 'NCT00468468', 'briefTitle': 'Mentor Integration Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Mentor Integration Study', 'orgStudyIdInfo': {'id': '2003-192'}, 'secondaryIdInfos': [{'id': '1P50CA09817-01A1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHESS Condition', 'description': 'Subjects who receive the CHESS (Comprehensive Health Enhancement Support System)', 'interventionNames': ['Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor']}, {'type': 'EXPERIMENTAL', 'label': 'Mentor Condition', 'description': 'Subjects who receive access to a Human Cancer Mentor only', 'interventionNames': ['Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor']}, {'type': 'EXPERIMENTAL', 'label': 'CHESS + Mentor', 'description': 'Subjects who receive the CHESS system plus a Human Cancer Mentor', 'interventionNames': ['Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor']}, {'type': 'NO_INTERVENTION', 'label': 'Internet Only', 'description': 'Subjects receive routine care and nothing else'}], 'interventions': [{'name': 'CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor', 'type': 'BEHAVIORAL', 'description': 'computer based education and support', 'armGroupLabels': ['CHESS + Mentor', 'CHESS Condition', 'Mentor Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Robert Hawkins, PhD.', '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'}}}}