Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

Not Applicable

Withdrawn

• Conditions: Cancer Survivor; Cognitive/Functional Effects; Breast Cancer
• Interventions: Other: cognitive intervention; Other: computer-assisted cognitive training; Procedure: mind-body intervention procedure; Other: memory intervention; Other: questionnaire administration

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm IA (Lumosity, relaxation, compensatory strategies)	questionnaire administration	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, relaxation, compensatory strategy)	cognitive intervention	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 IA (Lumosity, relaxation, compensatory strategies)	mind-body intervention procedure	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, relaxation, compensatory strategy)	memory intervention	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 IA (Lumosity, relaxation, compensatory strategies)	memory intervention	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, relaxation, compensatory strategy)	questionnaire administration	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)	questionnaire administration	Participants complete Lumosity exercises as in Arm IA.
Arm IA (Lumosity, relaxation, compensatory strategies)	computer-assisted cognitive training	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 II (Lumosity only)	computer-assisted cognitive training	Participants complete Lumosity exercises as in Arm IA.
Arm IB (Active Journaling, relaxation, compensatory strategy)	mind-body intervention procedure	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.

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