Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

Stage IIIA Breast Cancer Clinical Trial

Official title:

Computerized Cognitive Retraining in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662335
• Other study ID #: 9363
• Secondary ID: NCI-2015-0219393
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: December 11, 2017
• Start date: May 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2017
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 30, 2017
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• 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

Intervention

Other:
• Computer-Assisted Cognitive Training
Participate in Cogmed computerized working memory training
• Questionnaire Administration
Ancillary studies

Procedure:
• Standard Follow-Up Care
Undergo standard follow-up care

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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