Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors
NCT ID: NCT02166983
Last Updated: 2014-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm IA (Lumosity, relaxation, compensatory strategies)
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.
computer-assisted cognitive training
Complete Lumosity cognitive exercises
mind-body intervention procedure
Complete relaxation exercises
memory intervention
Complete compensatory strategies
questionnaire administration
Ancillary studies
Arm IB (Active Journaling, relaxation, compensatory strategy)
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.
cognitive intervention
Complete Active Journaling cognitive exercises
mind-body intervention procedure
Complete relaxation exercises
memory intervention
Complete compensatory strategies
questionnaire administration
Ancillary studies
Arm II (Lumosity only)
Participants complete Lumosity exercises as in Arm IA.
computer-assisted cognitive training
Complete Lumosity cognitive exercises
questionnaire administration
Ancillary studies
Interventions
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computer-assisted cognitive training
Complete Lumosity cognitive exercises
cognitive intervention
Complete Active Journaling cognitive exercises
mind-body intervention procedure
Complete relaxation exercises
memory intervention
Complete compensatory strategies
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received chemotherapy treatment for breast cancer diagnosis
* Chemotherapy-free for at least one year
Exclusion Criteria
* Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
* Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
* Pregnancy
21 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
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Principal Investigators
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Shelli Kesler
Role: PRINCIPAL_INVESTIGATOR
Stanford University Hospitals and Clinics
Locations
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Stanford University Hospitals and Clinics
Stanford, California, United States
Countries
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Other Identifiers
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NCI-2013-02353
Identifier Type: REGISTRY
Identifier Source: secondary_id
BRS0037
Identifier Type: OTHER
Identifier Source: secondary_id
BRS0037
Identifier Type: -
Identifier Source: org_study_id