Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Cancer Survivor; Stage IA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage 0 Breast Cancer; Stage IB Breast Cancer; Stage IIIA Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer
• Interventions: Other: Computer-Assisted Cognitive Training; Other: Questionnaire Administration; Procedure: Standard Follow-Up Care

• Registration Number: NCT02662335
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Study Start: 2016-05
• Primary Completion: 2016-12-13
• Study Completion: 2017-11-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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)
• Able to read, write, and speak English
• Mini Mental State Exam score greater than or equal to 19
• Have reliable internet and daily access to computer with audio/speakers
• 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

Exclusion Criteria

• History of multiple cancers
• History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery
• History of traumatic brain injury
• Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease
• Self-report of learning disabilities
• Substance addiction
• Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder
• Mini mental state exam score less than 19
• Previous participation in cognitive training program
• Visual impairments such as uncorrected vision or color blindness
• Uncorrected hearing impairments
• Self-report that they are not pregnant or planning to become pregnant in the next four months
• Anticipate moving from the region in the next 4 months
• Inability to use a mouse or computer keys to navigate around the computer screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (computer-assisted cognitive training)	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 I (computer-assisted cognitive training)	Questionnaire Administration	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)	Standard Follow-Up Care	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.
Arm II (wait-list)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Satisfaction, measured by the satisfaction survey	Up to 7 weeks	Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
Percentage of participants who are recruited	Up to 7 weeks	Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Percentage of participants retained in the study	Up to 7 weeks	Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Attrition rate	Up to 7 weeks	Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.

Secondary Outcome Measures

Name	Time	Method
Depression	Baseline to up to 7 weeks	PROMIS Emotional Distress -Depression Short Form.
Anxiety	Baseline to up to 7 weeks	PROMIS Emotional Distress-Anxiety-Short Form.
Cognition	Baseline to up to 7 weeks	FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.
Executive Function	Baseline to up to 7 weeks	D-KEFS color word tests, Trails A and B, and Letter-number sequencing.
Verbal Working Memory	Baseline to up to 7 weeks	REY auditory verbal word memory recall and recognition test.
Fatigue	Baseline to up to 7 weeks	PROMIS Fatigue-Short Form.
Visuo Spatial Working Memory	Baseline to up to 7 weeks	Symbol recognition and coding test.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States