Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Cognitive Enhancement Program

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02166983
• Other study ID #: BRS0037
• Secondary ID: NCI-2013-02353BR
• Status: Withdrawn
• Phase: N/A
• First received: December 16, 2013
• Last updated: November 21, 2014
• Start date: January 2014

Study information

• Verified date: November 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Cancer Survivor
• Cognitive/Functional Effects

Intervention

Other:
• computer-assisted cognitive training
Complete Lumosity cognitive exercises
• cognitive intervention
Complete Active Journaling cognitive exercises

Procedure:
• mind-body intervention procedure
Complete relaxation exercises

Other:
• memory intervention
Complete compensatory strategies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized Executive Function Test Composite Score		Baseline to 3 months	No