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Clinical Trials/NCT02166983
NCT02166983
Withdrawn
Not Applicable

Cognitive Enhancement Program

Stanford University1 site in 1 countryJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Stanford University
Locations
1
Primary Endpoint
Standardized Executive Function Test Composite Score
Status
Withdrawn
Last Updated
11 years ago

Overview

Brief Summary

This randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.

Detailed Description

PRIMARY OBJECTIVES: I. To improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (Cognitive Enhancement Program): Participants are randomized to 1 of 2 arms. ARM IA (Lumosity): Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible. ARM IB (Active Journaling): Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA. ARM II (Lumosity only): Participants complete Lumosity cognitive exercises as in Arm IA.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
January 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Previous diagnosis of breast cancer
  • Received chemotherapy treatment for breast cancer diagnosis
  • Chemotherapy-free for at least one year

Exclusion Criteria

  • History of learning disability, head trauma, neurologic disorder or significant psychiatric condition
  • Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
  • Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
  • Pregnancy

Outcomes

Primary Outcomes

Standardized Executive Function Test Composite Score

Time Frame: Baseline to 3 months

Study Sites (1)

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