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

November 7, 2019 updated by: University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Cognitive Intervention
Participate in memory and thinking skills workshop
Procedure: Functional Magnetic Resonance Imaging
Undergo functional neuroimaging
Other Names:
  • fMRI
  • FUNCTIONAL MRI
Other: Memory Intervention
Participate in memory and thinking skills workshop
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Functional Magnetic Resonance Imaging
Undergo functional neuroimaging
Other Names:
  • fMRI
  • FUNCTIONAL MRI
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
Time Frame: Pre-workshop to 7 weeks post-workshop
Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Pre-workshop to 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
Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Pre-workshop to 7 weeks post-workshop
Changes in neural function measured by fMRI BOLD signal
Time Frame: Pre-workshop to 7 weeks post-workshop
MRI functional imaging assessments while performing cognitive tasks.
Pre-workshop to 7 weeks post-workshop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Heidi Gray, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2012

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (ESTIMATE)

July 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7750 (OTHER: Fred Hutch/University of Washington Cancer Consortium)
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2012-01035 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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