Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
Primary Purpose
Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-Assisted Cognitive Training
Questionnaire Administration
Standard Follow-Up Care
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Survivor
Eligibility Criteria
Inclusion Criteria:
- Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
- Able to read, write, and speak English
- Mini Mental State Exam score greater than or equal to 19
- Have reliable internet and daily access to computer with audio/speakers
- Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study
Exclusion Criteria:
- History of multiple cancers
- History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery
- History of traumatic brain injury
- Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease
- Self-report of learning disabilities
- Substance addiction
- Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder
- Mini mental state exam score less than 19
- Previous participation in cognitive training program
- Visual impairments such as uncorrected vision or color blindness
- Uncorrected hearing impairments
- Self-report that they are not pregnant or planning to become pregnant in the next four months
- Anticipate moving from the region in the next 4 months
- Inability to use a mouse or computer keys to navigate around the computer screen
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (computer-assisted cognitive training)
Arm II (wait-list)
Arm Description
Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
Outcomes
Primary Outcome Measures
Attrition rate
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Percentage of participants retained in the study
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Percentage of participants who are recruited
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Satisfaction, measured by the satisfaction survey
Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
Secondary Outcome Measures
Anxiety
PROMIS Emotional Distress-Anxiety-Short Form.
Cognition
FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.
Depression
PROMIS Emotional Distress -Depression Short Form.
Executive Function
D-KEFS color word tests, Trails A and B, and Letter-number sequencing.
Fatigue
PROMIS Fatigue-Short Form.
Verbal Working Memory
REY auditory verbal word memory recall and recognition test.
Visuo Spatial Working Memory
Symbol recognition and coding test.
Full Information
NCT ID
NCT02662335
First Posted
January 20, 2016
Last Updated
December 11, 2017
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02662335
Brief Title
Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
Official Title
Computerized Cognitive Retraining in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 13, 2016 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. The severity of these cognitive deficits is associated with a significant negative impact on daily function and quality of life. A computerized cognitive retraining method may help researchers find ways to improve cognitive function and quality of life in breast cancer survivors.
Detailed Description
PRIMARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of a 6-week computerized working memory training program in breast cancer survivors who subjectively report cognitive deficits: evaluate feasibility of study procedures (recruitment and screening procedures, number of participants recruited, screened, and retained, attrition rate and reason, weekly phone calls completed with participants); evaluate the acceptability of an adaptive computerized working memory training intervention (burden, adherence to training schedule, performance level achieved, and participant satisfaction with computerized exercises).
SECONDARY OBJECTIVES:
I. To evaluate the difference in the posttest means at T2 (week #7) adjusted for T1 (baselines) in the primary working memory outcomes of visuo-spatial working memory (VSWM), visual working memory (VWM), and executive function (EF) as measured by the neuropsychological tests (Rey Auditory Test, Wechsler Adult Intelligence Scale [WAIS] IV symbol test, WAIS IV coding test, Delis-Kaplan Executive Function System [DKFES] color tests, Trails A and Trails B tests, and WAIS IV Letter and Number sequencing test) and self-report Patient Reported Outcomes Measurement Information System (PROMIS) surveys (Applied Cognition General Concerns Short Form, Applied Cognition Executive Function Short Form, and Functional Assessment of Cancer Therapy [FACT] Cognitive Function) between the intervention group and wait control group.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (COMPUTER-ASSISTED COGNITIVE TRAINING): Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
ARM II (WAIT LIST): Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (computer-assisted cognitive training)
Arm Type
Experimental
Arm Description
Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
Arm Title
Arm II (wait-list)
Arm Type
Active Comparator
Arm Description
Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
Intervention Type
Other
Intervention Name(s)
Computer-Assisted Cognitive Training
Intervention Description
Participate in Cogmed computerized working memory training
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Standard Follow-Up Care
Intervention Description
Undergo standard follow-up care
Primary Outcome Measure Information:
Title
Attrition rate
Description
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Time Frame
Up to 7 weeks
Title
Percentage of participants retained in the study
Description
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Time Frame
Up to 7 weeks
Title
Percentage of participants who are recruited
Description
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Time Frame
Up to 7 weeks
Title
Satisfaction, measured by the satisfaction survey
Description
Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
Time Frame
Up to 7 weeks
Secondary Outcome Measure Information:
Title
Anxiety
Description
PROMIS Emotional Distress-Anxiety-Short Form.
Time Frame
Baseline to up to 7 weeks
Title
Cognition
Description
FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.
Time Frame
Baseline to up to 7 weeks
Title
Depression
Description
PROMIS Emotional Distress -Depression Short Form.
Time Frame
Baseline to up to 7 weeks
Title
Executive Function
Description
D-KEFS color word tests, Trails A and B, and Letter-number sequencing.
Time Frame
Baseline to up to 7 weeks
Title
Fatigue
Description
PROMIS Fatigue-Short Form.
Time Frame
Baseline to up to 7 weeks
Title
Verbal Working Memory
Description
REY auditory verbal word memory recall and recognition test.
Time Frame
Baseline to up to 7 weeks
Title
Visuo Spatial Working Memory
Description
Symbol recognition and coding test.
Time Frame
Baseline to up to 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
Able to read, write, and speak English
Mini Mental State Exam score greater than or equal to 19
Have reliable internet and daily access to computer with audio/speakers
Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study
Exclusion Criteria:
History of multiple cancers
History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery
History of traumatic brain injury
Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease
Self-report of learning disabilities
Substance addiction
Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder
Mini mental state exam score less than 19
Previous participation in cognitive training program
Visual impairments such as uncorrected vision or color blindness
Uncorrected hearing impairments
Self-report that they are not pregnant or planning to become pregnant in the next four months
Anticipate moving from the region in the next 4 months
Inability to use a mouse or computer keys to navigate around the computer screen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Shannon Dorcy
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
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