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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02353 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| BRS0037 | Other Identifier | Stanford University Hospitals and Clinics | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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PI left Stanford
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm IA (Lumosity, relaxation, compensatory strategies) | Experimental | 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) | Experimental | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computer-assisted cognitive training | Other | Complete Lumosity cognitive exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Executive Function Test Composite Score | Baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelli Kesler | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | United States |
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| Experimental |
Participants complete Lumosity exercises as in Arm IA. |
|
| cognitive intervention | Other | Complete Active Journaling cognitive exercises |
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| mind-body intervention procedure | Procedure | Complete relaxation exercises |
|
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| memory intervention | Other | Complete compensatory strategies |
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| questionnaire administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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