Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-28 @ 12:58 PM
Study NCT ID:
NCT01141868
Status:
WITHDRAWN
Last Update Posted:
2013-05-17
First Post:
2010-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072638', 'term': 'Patient Portals'}], 'ancestors': [{'id': 'D055991', 'term': 'Health Records, Personal'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study never opened due to technical upgrades that were needed for the SHUTi computer system.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep efficiency', 'timeFrame': '6 weeks', 'description': 'sleep-onset latency, wake after sleep onset, and number of awakenings'}], 'secondaryOutcomes': [{'measure': 'total sleep time', 'timeFrame': '6 wks', 'description': 'total hours of sleep per 24 hour period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insomnia', 'breast cancer survivor', 'Internet intervention'], 'conditions': ['Insomnia', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be assigned to either gain access to the 6-week treatment program immediately (experimental group) or following study participation (control group).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Female\n* Diagnosed with breast cancer\n* Age 18 and older\n* Completed primary treatment at least one month prior to enrollment\n* Diagnosis of insomnia\n\nExclusion criteria:\n\n* Experiencing a sleep disorder other than insomnia (e.g., sleep apnea)\n* Experiencing a major depressive episode or other serious psychiatric disturbance\n* Modification of psychotropic medications within the previous month\n* Undergoing current psychotherapy treatment'}, 'identificationModule': {'nctId': 'NCT01141868', 'briefTitle': 'Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '31944EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet Intervention', 'interventionNames': ['Behavioral: Internet Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Intervention', 'description': 'Receive access to the online Internet intervention after completing post-assessments.', 'interventionNames': ['Behavioral: Internet Intervention']}], 'interventions': [{'name': 'Internet Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Internet'], 'description': 'online treatment for insomnia', 'armGroupLabels': ['Delayed Intervention', 'Internet Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jane Schubart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jane Schubart, PhD', 'oldOrganization': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'}}}}