Breast Cancer, Cancer Survivor, Cognitive/Functional Effects
Conditions
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.
Interventions
Complete Lumosity cognitive exercises
OTHERcognitive intervention
Complete Active Journaling cognitive exercises
PROCEDUREmind-body intervention procedure
Complete relaxation exercises
OTHERmemory intervention
Complete compensatory strategies
OTHERquestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized Executive Function Test Composite Score | Baseline to 3 months |
Countries
United States
Outcome results
None listed