Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Washington
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01641068
First received: July 12, 2012
Last updated: June 2, 2016
Last verified: June 2016

July 12, 2012
June 2, 2016
September 2012
September 2017   (final data collection date for primary outcome measure)
  • Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire [ Time Frame: Pre-workshop to 7 weeks post-workshop ] [ Designated as safety issue: No ]
    Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
  • Change in score on the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire [ Time Frame: Pre-workshop to 7 weeks post-workshop ] [ Designated as safety issue: No ]
    Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
  • Changes in neural function measured by fMRI BOLD signal [ Time Frame: Pre-workshop to 7 weeks post-workshop ] [ Designated as safety issue: No ]
    MRI functional imaging assessments while performing cognitive tasks.
  • Changes in cognitive performance and QOL pre and post participation in a cognitive rehabilitation intervention [ Time Frame: Baseline to 7 weeks ] [ Designated as safety issue: No ]
    The behavioral data (tests and questionnaires) will be entered into SPSS statistical software and analyzed. A mixed model (group by time) multivariate analysis of variance (MANOVA) will be used to determine if an interaction occurs between the treatment group and control (CL) over time, which will be further confirmed with post-hoc analyses.
  • Changes in neural function measured by fMRI BOLD signal and corresponding behavioral responses while performing cognitive tasks [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
    Software from the fMRI for the Brain (FMRIB) Software Library will be used to analyze fMRI data and a paired T-test will be used to compare resting state images with paired associate recall images. Prior to automated procedures each functional series will be manually reviewed and aberrant volumes or extreme motion artifacts will be removed. Both a whole brain and region of interest (ROI) analysis will be conducted for cognitive task scans.
Complete list of historical versions of study NCT01641068 on ClinicalTrials.gov Archive Site
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Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
Behavioral and Neural Indices of Cognitive Rehabilitation in Women's Cancer: A Pilot Study
The purpose of this study is to examine thinking abilities, mood, and quality of life in cancer survivors before and after an 8-week group-based memory and thinking skills workshop. Research participants will include people treated for cancer in the past. Researchers would like to know if there is a relationship between baseline performance on timed attention and memory tasks before receiving memory and thinking skills workshop designed to improve cognition, and performance on such tasks after the workshop.

PRIMARY OBJECTIVES:

I. To objectively assess changes in cognitive performance and quality of life (QOL) pre and post participation in a cognitive rehabilitation intervention in gynecologic and breast cancer survivors who have undergone chemotherapy.

II. To measure changes in neural function as measured by functional magnetic resonance imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral responses while performing cognitive tasks.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (Skills workshop): Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).

ARM II (Education workshop): Patients participate in education workshop for 7 weeks 1-hour duration group focusing on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Carcinoma
  • Cancer Survivor
  • Cognitive Side Effects of Cancer Therapy
  • Malignant Female Reproductive System Neoplasm
  • Other: Cognitive Intervention
    Participate in memory and thinking skills workshop
  • Other: Educational Intervention
    Participate in workshops focusing on increasing knowledge and education on the brain and cognition
    Other Names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Procedure: Functional Magnetic Resonance Imaging
    Undergo functional neuroimaging
    Other Names:
    • fMRI
    • FUNCTIONAL MRI
  • Other: Memory Intervention
    Participate in memory and thinking skills workshop
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Experimental: Arm I (memory and thinking skills workshop)
    Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
    Interventions:
    • Other: Cognitive Intervention
    • Procedure: Functional Magnetic Resonance Imaging
    • Other: Memory Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Active Comparator: Arm II (Education Workshop)
    Patients participate in 7 weekly 1-hour group workshops focusing on increasing knowledge and education on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3). Patients are then given the option to participate in the memory and thinking skills workshop.
    Interventions:
    • Other: Educational Intervention
    • Procedure: Functional Magnetic Resonance Imaging
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment
  • Prior treatment of gynecologic or breast cancer with chemotherapy
  • Completion of treatment (e.g., chemotherapy, radiation therapy, surgery, etc.) for gynecologic or breast cancer 6 months or greater in the past
  • Able to comprehend and speak English
  • For the subset of participants who will undergo magnetic resonance imaging (MRI), ability to withstand lying down in small area (MRI scanner) for 50 minutes
  • Completion of successful fMRI safety screening
  • Able to give informed consent
  • Able to undergo informed consent procedures and 3 hours of testing, plus 8 1-hour cognitive rehabilitation sessions with breaks

Exclusion Criteria:

  • Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
  • Cancer onset before the age of 21
  • Unstable medical problems (such as unstable heart disease, unstable hypertension, diabetes in poor control, respiratory disease complicated by hypoxia or hypercapnia, infectious illnesses, unstable thyroid dysfunction, currently hospitalized)
  • History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization; mild depression or stable anti-depressants, and anti-seizure medications are acceptable; anti-anxiety medications may be acceptable
  • Current alcohol over-use as defined by currently consuming 4 drinks or more per day or binge drinking (6 or more drinks in one night) within the past week
  • History of or current neurological illness that significantly impacts cognition (e.g. stroke, multiple sclerosis, Parkinson's disease, Alzheimer's disease, head injury, epilepsy, etc)
  • History of brain injury that significantly impacted cognition; as indicated responses on the Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) greater or equal to any of the following: 30 minutes or more of loss of consciousness (LOC), two or more mild cases within two weeks of each other, or any injury with loss of consciousness before the age of 15
  • History of central nervous system (CNS) tumor
  • A score of 25 or more on the Patient Health Questionnaire (PHQ-9) on the first visit
  • A score of 26 or below on the Mini Mental Status Exam (MMSE) triggers a review by an investigational team before enrolling
  • A score above 45 on the Wender Utah Rating Scale for attention deficit disorder (ADD) (WURS)
  • For the subset of participants undergoing neuroimaging:

    • Medical history or devices which make an MRI unsafe or uncomfortable (e.g., magnetic rods or pins, metal plates or screws, pacemaker)
Female
21 Years to 90 Years   (Adult, Senior)
No
United States
 
NCT01641068
7750, NCI-2012-01035, 7750, P30CA015704
No
Not Provided
Not Provided
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Heidi Gray Fred Hutch/University of Washington Cancer Consortium
University of Washington
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP