Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-04-25 @ 1:57 PM
Study NCT ID:
NCT02866994
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Connect Online: An Internet-based Intervention for Women With Breast Cancer
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychological mediator and moderator assessment', 'timeFrame': 'Baseline, 2 months, 4 months', 'description': 'phone and web based assessment: Comparative effectiveness of the two conditions will be evaluated with analysis of covariance (ANCOVA), in which the dependent variable is CES-D (Center for Epidemiologic Studies-Depression scale, condition assignment and any variables on which baseline imbalance is observed.'}], 'primaryOutcomes': [{'measure': 'Change of general and cancer-related psychological status', 'timeFrame': 'Baseline, 2 months, 4 months', 'description': 'web site self reported'}], 'secondaryOutcomes': [{'measure': 'Change in overall physical health status', 'timeFrame': 'Baseline, 2 months, 4 months', 'description': 'web site self reported'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Women'], 'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women at least 18 years of age;\n* first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;\n* ability to complete the intervention and assessments in English; and\n* willingness to attend in-person PCO workshop;\n\nExclusion Criteria:\n\n* male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);\n* local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and\n* use of a personal website to post cancer-relevant material in the past six months'}, 'identificationModule': {'nctId': 'NCT02866994', 'acronym': 'PCO', 'briefTitle': 'Project Connect Online: An Internet-based Intervention for Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)', 'orgStudyIdInfo': {'id': '14-001744'}, 'secondaryIdInfos': [{'id': '20155036', 'type': 'OTHER_GRANT', 'domain': 'Breast Cancer Research Foundation'}, {'id': 'SAC110009', 'type': 'OTHER_GRANT', 'domain': 'Susan G. Komen Breast Cancer Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project Connect Online (PCO)', 'description': 'Creation of personal website to share breast cancer experience with friends and family', 'interventionNames': ['Behavioral: Project Connect Online']}, {'type': 'EXPERIMENTAL', 'label': 'PCO PLUS', 'description': 'Creation of personal website to share breast cancer experience with friends and family, as well as other women diagnosed with breast cancer', 'interventionNames': ['Behavioral: PCO PLUS']}], 'interventions': [{'name': 'Project Connect Online', 'type': 'BEHAVIORAL', 'description': 'Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family', 'armGroupLabels': ['Project Connect Online (PCO)']}, {'name': 'PCO PLUS', 'type': 'BEHAVIORAL', 'description': 'Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family, as well as other women diagnosed with breast cancer', 'armGroupLabels': ['PCO PLUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Patricia Ganz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Proffessor and Director, Health Policy & Management'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Susan G. Komen Breast Cancer Foundation', 'class': 'OTHER'}, {'name': 'Breast Cancer Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}