search
Back to results

Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Cancer Survivor, Cognitive/Functional Effects

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computer-assisted cognitive training
cognitive intervention
mind-body intervention procedure
memory intervention
questionnaire administration
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm IA (Lumosity, relaxation, compensatory strategies)

Arm IB (Active Journaling, relaxation, compensatory strategy)

Arm II (Lumosity only)

Arm Description

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.

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.

Participants complete Lumosity exercises as in Arm IA.

Outcomes

Primary Outcome Measures

Standardized Executive Function Test Composite Score

Secondary Outcome Measures

Full Information

First Posted
December 16, 2013
Last Updated
November 21, 2014
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02166983
Brief Title
Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors
Official Title
Cognitive Enhancement Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
PI left Stanford
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer Survivor, Cognitive/Functional Effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm IA (Lumosity, relaxation, compensatory strategies)
Arm Type
Experimental
Arm Description
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 Title
Arm IB (Active Journaling, relaxation, compensatory strategy)
Arm Type
Experimental
Arm Description
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 Title
Arm II (Lumosity only)
Arm Type
Experimental
Arm Description
Participants complete Lumosity exercises as in Arm IA.
Intervention Type
Other
Intervention Name(s)
computer-assisted cognitive training
Intervention Description
Complete Lumosity cognitive exercises
Intervention Type
Other
Intervention Name(s)
cognitive intervention
Intervention Description
Complete Active Journaling cognitive exercises
Intervention Type
Procedure
Intervention Name(s)
mind-body intervention procedure
Other Intervention Name(s)
mind-body interventions
Intervention Description
Complete relaxation exercises
Intervention Type
Other
Intervention Name(s)
memory intervention
Intervention Description
Complete compensatory strategies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Standardized Executive Function Test Composite Score
Time Frame
Baseline to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelli Kesler
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

We'll reach out to this number within 24 hrs