Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

NCT02662335 | Completed DMC

• 3 other identifiers: 9363NCI-2015-02193P30CA015704
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Anxiety

  Baseline to up to 7 weeks

• Cognition

  Baseline to up to 7 weeks

• Depression

  Baseline to up to 7 weeks

• Executive Function

  Baseline to up to 7 weeks

• Fatigue

  Baseline to up to 7 weeks

Study Arms (2)

Arm I (computer-assisted cognitive training)

EXPERIMENTAL

Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.

Other: Computer-Assisted Cognitive Training; Other: Questionnaire Administration

Arm II (wait-list)

ACTIVE COMPARATOR

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; Procedure: Standard Follow-Up Care

Interventions

Computer-Assisted Cognitive Training OTHER

Participate in Cogmed computerized working memory training

Arm I (computer-assisted cognitive training)

Questionnaire Administration OTHER

Ancillary studies

Arm I (computer-assisted cognitive training); Arm II (wait-list)

Standard Follow-Up Care PROCEDURE

Undergo standard follow-up care

Arm II (wait-list)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kathleen Shannon Dorcy

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: May 1, 2016
• Primary Completion: December 13, 2016
• Study Completion: November 30, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

US (1)