Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

NCT02166983 — Not applicable, Withdrawn, Stanford University

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Cognitive Enhancement Program

RegistryNCT02166983
StatusWithdrawn - PI left Stanford
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
SponsorStanford University (Other); collaborators: National Cancer Institute (NCI)
ConditionsBreast Cancer, Cancer Survivor, Cognitive/Functional Effects
Interventionscomputer-assisted cognitive training, cognitive intervention, mind-body intervention procedure, memory intervention, questionnaire administration (Other, procedure)
Datesstart 2014-01-01, primary completion 2016-01-01 (estimated), first posted 2014-06-18, last updated 2014-11-24
Locations1 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Arm IA (Lumosity, relaxation, compensatory strategies)ExperimentalOther: computer-assisted cognitive training; Procedure: mind-body intervention procedure; Other: memory intervention; Other: questionnaire administrationParticipants 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)ExperimentalOther: cognitive intervention; Procedure: mind-body intervention procedure; Other: memory intervention; Other: questionnaire administrationParticipants 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)ExperimentalOther: computer-assisted cognitive training; Other: questionnaire administrationParticipants complete Lumosity exercises as in Arm IA.
  • computer-assisted cognitive training (Other): Complete Lumosity cognitive exercises
  • cognitive intervention (Other): Complete Active Journaling cognitive exercises
  • mind-body intervention procedure (Procedure), also known as mind-body interventions: Complete relaxation exercises
  • memory intervention (Other): Complete compensatory strategies
  • questionnaire administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

  • Standardized Executive Function Test Composite Score [Baseline to 3 months]

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Stanford University Hospitals and ClinicsStanford, CaliforniaUnited States

+Investigators

  • Shelli Kesler, Principal investigator, Stanford University Hospitals and Clinics

+Funding

NIH grants: P30CA124435