Clinical trial NCT02662335: Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
Official title: Computerized Cognitive Retraining in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-01-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attrition rate
timeFrame: Up to 7 weeks
measure: Percentage of participants retained in the study
timeFrame: Up to 7 weeks
measure: Percentage of participants who are recruited
timeFrame: Up to 7 weeks
measure: Satisfaction, measured by the satisfaction survey
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline to up to 7 weeks
measure: Cognition
timeFrame: Baseline to up to 7 weeks
measure: Depression
timeFrame: Baseline to up to 7 weeks
measure: Executive Function
timeFrame: Baseline to up to 7 weeks
measure: Fatigue
timeFrame: Baseline to up to 7 weeks
measure: Verbal Working Memory
timeFrame: Baseline to up to 7 weeks
measure: Visuo Spatial Working Memory
timeFrame: Baseline to up to 7 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Kathleen Shannon Dorcy
role: PRINCIPAL_INVESTIGATOR
References: