Cognitive Enhancement Program
| Registry | NCT02166983 |
|---|---|
| Status | Withdrawn - PI left Stanford |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Sponsor | Stanford University (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Breast Cancer, Cancer Survivor, Cognitive/Functional Effects |
| Interventions | computer-assisted cognitive training, cognitive intervention, mind-body intervention procedure, memory intervention, questionnaire administration (Other, procedure) |
| Dates | start 2014-01-01, primary completion 2016-01-01 (estimated), first posted 2014-06-18, last updated 2014-11-24 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials for Cancer Survivor All trials of computer-assisted cognitive training All trials of cognitive intervention
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm IA (Lumosity, relaxation, compensatory strategies) | Experimental | Other: computer-assisted cognitive training; Procedure: mind-body intervention procedure; Other: memory intervention; Other: 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) | Experimental | Other: cognitive intervention; Procedure: mind-body intervention procedure; Other: memory intervention; Other: 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) | Experimental | Other: computer-assisted cognitive training; Other: questionnaire administration | Participants complete Lumosity exercises as in Arm IA. |
Sex: Female, ages: 21 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford, California | United States |
NIH grants: P30CA124435