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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-02193 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9363 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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).
SECONDARY OBJECTIVES:
I. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 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.
ARM 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (computer-assisted cognitive training) | Experimental | Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks. |
|
| Arm II (wait-list) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Assisted Cognitive Training | Other | Participate in Cogmed computerized working memory training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attrition rate | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks |
| Percentage of participants retained in the study | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks |
| Percentage of participants who are recruited | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks |
| Satisfaction, measured by the satisfaction survey | Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey. | Up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | PROMIS Emotional Distress-Anxiety-Short Form. | Baseline to up to 7 weeks |
| Cognition | FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Shannon Dorcy | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
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| Standard Follow-Up Care | Procedure | Undergo standard follow-up care |
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| Baseline to up to 7 weeks |
| Depression | PROMIS Emotional Distress -Depression Short Form. | Baseline to up to 7 weeks |
| Executive Function | D-KEFS color word tests, Trails A and B, and Letter-number sequencing. | Baseline to up to 7 weeks |
| Fatigue | PROMIS Fatigue-Short Form. | Baseline to up to 7 weeks |
| Verbal Working Memory | REY auditory verbal word memory recall and recognition test. | Baseline to up to 7 weeks |
| Visuo Spatial Working Memory | Symbol recognition and coding test. | Baseline to up to 7 weeks |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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