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Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02662335
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
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 Other: Computer-Assisted Cognitive Training Other: Questionnaire Administration Procedure: Standard Follow-Up Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Computerized Cognitive Retraining in Breast Cancer Survivors
Study Start Date : May 2016
Actual Primary Completion Date : December 13, 2016
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Computer-Assisted Cognitive Training
Participate in Cogmed computerized working memory training

Other: Questionnaire Administration
Ancillary studies

Active Comparator: 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.
Other: Questionnaire Administration
Ancillary studies

Procedure: Standard Follow-Up Care
Undergo standard follow-up care




Primary Outcome Measures :
  1. Attrition rate [ Time Frame: Up to 7 weeks ]
    Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.

  2. Percentage of participants retained in the study [ Time Frame: Up to 7 weeks ]
    Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.

  3. Percentage of participants who are recruited [ Time Frame: Up to 7 weeks ]
    Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.

  4. Satisfaction, measured by the satisfaction survey [ Time Frame: Up to 7 weeks ]
    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 :
  1. Anxiety [ Time Frame: Baseline to up to 7 weeks ]
    PROMIS Emotional Distress-Anxiety-Short Form.

  2. Cognition [ Time Frame: Baseline to up to 7 weeks ]
    FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.

  3. Depression [ Time Frame: Baseline to up to 7 weeks ]
    PROMIS Emotional Distress -Depression Short Form.

  4. Executive Function [ Time Frame: Baseline to up to 7 weeks ]
    D-KEFS color word tests, Trails A and B, and Letter-number sequencing.

  5. Fatigue [ Time Frame: Baseline to up to 7 weeks ]
    PROMIS Fatigue-Short Form.

  6. Verbal Working Memory [ Time Frame: Baseline to up to 7 weeks ]
    REY auditory verbal word memory recall and recognition test.

  7. Visuo Spatial Working Memory [ Time Frame: Baseline to up to 7 weeks ]
    Symbol recognition and coding test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662335


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kathleen Shannon Dorcy Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02662335     History of Changes
Other Study ID Numbers: 9363
NCI-2015-02193 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9363 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type