Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

December 11, 2017 updated by: Fred Hutchinson Cancer Center

Computerized Cognitive Retraining in Breast Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Computer-Assisted Cognitive Training
Participate in Cogmed computerized working memory training
Active Comparator: 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Standard Follow-Up Care
Undergo standard follow-up care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attrition rate
Time Frame: 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.
Up to 7 weeks
Percentage of participants retained in the study
Time Frame: 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.
Up to 7 weeks
Percentage of participants who are recruited
Time Frame: 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.
Up to 7 weeks
Satisfaction, measured by the satisfaction survey
Time Frame: 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.
Up to 7 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 13, 2016

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9363 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2015-02193 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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