Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

Not Applicable

Withdrawn

• Conditions: Cancer Survivor; Cognitive/Functional Effects; Breast Cancer

• Registration Number: NCT02166983
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2013-12-16
• Study Start: 2014-01
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-21
• Last Update Posted: 2014-11-24
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Standardized Executive Function Test Composite Score	Baseline to 3 months

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States