Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Stage IIIA Breast Cancer
Stage IB Breast Cancer
Stage IIIB Breast Cancer
Stage IIB Breast Cancer
Stage IIA Breast Cancer
Stage IIIC Breast Cancer
Stage IA Breast Cancer
Cancer Survivor
Stage 0 Breast Cancer

Treatments

Other: Questionnaire Administration
Procedure: Standard Follow-Up Care
Other: Computer-Assisted Cognitive Training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02662335
NCI-2015-02193 (Registry Identifier)
9363 (Other Identifier)
P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Arm I (computer-assisted cognitive training)
Experimental group
Description:
Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
Treatment:
Other: Computer-Assisted Cognitive Training
Other: Questionnaire Administration
Arm II (wait-list)
Active Comparator group
Description:
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.
Treatment:
Procedure: Standard Follow-Up Care
Other: Questionnaire Administration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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