Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Enhancement Program

Conditions
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Breast Cancer, Cancer Survivor, Cognitive/Functional Effects

Intervention / Treatment
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* Other: computer-assisted cognitive training
* Other: cognitive intervention
* Procedure: mind-body intervention procedure
* Other: memory intervention
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm IA (Lumosity, relaxation, compensatory strategies)<br>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. | Other: computer-assisted cognitive training<br>* Complete Lumosity cognitive exercises<br>Procedure: mind-body intervention procedure<br>* Complete relaxation exercises<br>* Other names: mind-body interventions;Other: memory intervention<br>* Complete compensatory strategies<br>Other: questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Arm IB (Active Journaling, relaxation, compensatory strategy)<br>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. | Other: cognitive intervention<br>* Complete Active Journaling cognitive exercises<br>Procedure: mind-body intervention procedure<br>* Complete relaxation exercises<br>* Other names: mind-body interventions;Other: memory intervention<br>* Complete compensatory strategies<br>Other: questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Arm II (Lumosity only)<br>Participants complete Lumosity exercises as in Arm IA. | Other: computer-assisted cognitive training<br>* Complete Lumosity cognitive exercises<br>Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Executive Function Test Composite Score |  | Baseline to 3 months |