Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT02662335
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attrition rate', 'timeFrame': 'Up to 7 weeks', 'description': 'Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.'}, {'measure': 'Percentage of participants retained in the study', 'timeFrame': 'Up to 7 weeks', 'description': 'Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.'}, {'measure': 'Percentage of participants who are recruited', 'timeFrame': 'Up to 7 weeks', 'description': 'Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.'}, {'measure': 'Satisfaction, measured by the satisfaction survey', 'timeFrame': 'Up to 7 weeks', 'description': 'Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'PROMIS Emotional Distress-Anxiety-Short Form.'}, {'measure': 'Cognition', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.'}, {'measure': 'Depression', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'PROMIS Emotional Distress -Depression Short Form.'}, {'measure': 'Executive Function', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'D-KEFS color word tests, Trails A and B, and Letter-number sequencing.'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'PROMIS Fatigue-Short Form.'}, {'measure': 'Verbal Working Memory', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'REY auditory verbal word memory recall and recognition test.'}, {'measure': 'Visuo Spatial Working Memory', 'timeFrame': 'Baseline to up to 7 weeks', 'description': 'Symbol recognition and coding test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer Survivor', 'Stage 0 Breast Cancer', 'Stage IA Breast Cancer', 'Stage IB Breast Cancer', 'Stage IIA Breast Cancer', 'Stage IIB Breast Cancer', 'Stage IIIA Breast Cancer', 'Stage IIIB Breast Cancer', 'Stage IIIC Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. The severity of these cognitive deficits is associated with a significant negative impact on daily function and quality of life. A computerized cognitive retraining method may help researchers find ways to improve cognitive function and quality of life in breast cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate the feasibility and acceptability of a 6-week computerized working memory training program in breast cancer survivors who subjectively report cognitive deficits: evaluate feasibility of study procedures (recruitment and screening procedures, number of participants recruited, screened, and retained, attrition rate and reason, weekly phone calls completed with participants); evaluate the acceptability of an adaptive computerized working memory training intervention (burden, adherence to training schedule, performance level achieved, and participant satisfaction with computerized exercises).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the difference in the posttest means at T2 (week #7) adjusted for T1 (baselines) in the primary working memory outcomes of visuo-spatial working memory (VSWM), visual working memory (VWM), and executive function (EF) as measured by the neuropsychological tests (Rey Auditory Test, Wechsler Adult Intelligence Scale \\[WAIS\\] IV symbol test, WAIS IV coding test, Delis-Kaplan Executive Function System \\[DKFES\\] color tests, Trails A and Trails B tests, and WAIS IV Letter and Number sequencing test) and self-report Patient Reported Outcomes Measurement Information System (PROMIS) surveys (Applied Cognition General Concerns Short Form, Applied Cognition Executive Function Short Form, and Functional Assessment of Cancer Therapy \\[FACT\\] Cognitive Function) between the intervention group and wait control group.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I (COMPUTER-ASSISTED COGNITIVE TRAINING): Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.\n\nARM II (WAIT LIST): Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)\n* Able to read, write, and speak English\n* Mini Mental State Exam score greater than or equal to 19\n* Have reliable internet and daily access to computer with audio/speakers\n* Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study\n\nExclusion Criteria:\n\n* History of multiple cancers\n* History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery\n* History of traumatic brain injury\n* Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease\n* Self-report of learning disabilities\n* Substance addiction\n* Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder\n* Mini mental state exam score less than 19\n* Previous participation in cognitive training program\n* Visual impairments such as uncorrected vision or color blindness\n* Uncorrected hearing impairments\n* Self-report that they are not pregnant or planning to become pregnant in the next four months\n* Anticipate moving from the region in the next 4 months\n* Inability to use a mouse or computer keys to navigate around the computer screen"}, 'identificationModule': {'nctId': 'NCT02662335', 'briefTitle': 'Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Computerized Cognitive Retraining in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '9363'}, 'secondaryIdInfos': [{'id': 'NCI-2015-02193', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '9363', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (computer-assisted cognitive training)', 'description': 'Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.', 'interventionNames': ['Other: Computer-Assisted Cognitive Training', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (wait-list)', 'description': 'Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.', 'interventionNames': ['Other: Questionnaire Administration', 'Procedure: Standard Follow-Up Care']}], 'interventions': [{'name': 'Computer-Assisted Cognitive Training', 'type': 'OTHER', 'description': 'Participate in Cogmed computerized working memory training', 'armGroupLabels': ['Arm I (computer-assisted cognitive training)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (computer-assisted cognitive training)', 'Arm II (wait-list)']}, {'name': 'Standard Follow-Up Care', 'type': 'PROCEDURE', 'description': 'Undergo standard follow-up care', 'armGroupLabels': ['Arm II (wait-list)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Kathleen Shannon Dorcy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}