NCT02166983

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

December 16, 2013

Last Update Submit

November 21, 2014

Conditions

Breast CancerCancer SurvivorCognitive/Functional Effects

Outcome Measures

Primary Outcomes (1)

  • Standardized Executive Function Test Composite Score

    Baseline to 3 months

Study Arms (3)

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.

Other: computer-assisted cognitive trainingProcedure: mind-body intervention procedureOther: memory interventionOther: questionnaire administration

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.

Other: cognitive interventionProcedure: mind-body intervention procedureOther: memory interventionOther: questionnaire administration

Arm II (Lumosity only)

EXPERIMENTAL

Participants complete Lumosity exercises as in Arm IA.

Other: computer-assisted cognitive trainingOther: questionnaire administration

Interventions

computer-assisted cognitive trainingOTHER

Complete Lumosity cognitive exercises

Arm IA (Lumosity, relaxation, compensatory strategies)Arm II (Lumosity only)
cognitive interventionOTHER

Complete Active Journaling cognitive exercises

Arm IB (Active Journaling, relaxation, compensatory strategy)
mind-body intervention procedurePROCEDURE

Complete relaxation exercises

Also known as: mind-body interventions
Arm IA (Lumosity, relaxation, compensatory strategies)Arm IB (Active Journaling, relaxation, compensatory strategy)
memory interventionOTHER

Complete compensatory strategies

Arm IA (Lumosity, relaxation, compensatory strategies)Arm IB (Active Journaling, relaxation, compensatory strategy)
questionnaire administrationOTHER

Ancillary studies

Arm IA (Lumosity, relaxation, compensatory strategies)Arm IB (Active Journaling, relaxation, compensatory strategy)Arm II (Lumosity only)

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis of breast cancer
  • Received chemotherapy treatment for breast cancer diagnosis
  • Chemotherapy-free for at least one year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Shelli Kesler

    Stanford University Hospitals and Clinics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

June 18, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

US(1)