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

Primary Purpose

Breast Carcinoma, Cancer Survivor, Cognitive Side Effects of Cancer Therapy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Intervention
Educational Intervention
Functional Magnetic Resonance Imaging
Memory Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma focused on measuring Memory, Attention, Chemo-brain, Survivor, Treatment

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

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 (memory and thinking skills workshop)

Arm II (Education Workshop)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
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
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
MRI functional imaging assessments while performing cognitive tasks.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2012
Last Updated
November 7, 2019
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01641068
Brief Title
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
Official Title
Behavioral and Neural Indices of Cognitive Rehabilitation in Women's Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2012 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Cancer Survivor, Cognitive Side Effects of Cancer Therapy, Malignant Female Reproductive System Neoplasm
Keywords
Memory, Attention, Chemo-brain, Survivor, Treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm I (memory and thinking skills workshop)
Arm Type
Experimental
Arm Description
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 Title
Arm II (Education Workshop)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Intervention
Intervention Description
Participate in memory and thinking skills workshop
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Participate in workshops focusing on increasing knowledge and education on the brain and cognition
Intervention Type
Procedure
Intervention Name(s)
Functional Magnetic Resonance Imaging
Other Intervention Name(s)
fMRI, FUNCTIONAL MRI
Intervention Description
Undergo functional neuroimaging
Intervention Type
Other
Intervention Name(s)
Memory Intervention
Intervention Description
Participate in memory and thinking skills workshop
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
Description
Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Time Frame
Pre-workshop to 7 weeks post-workshop
Title
Change in score on the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire
Description
Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Time Frame
Pre-workshop to 7 weeks post-workshop
Title
Changes in neural function measured by fMRI BOLD signal
Description
MRI functional imaging assessments while performing cognitive tasks.
Time Frame
Pre-workshop to 7 weeks post-workshop

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Gray
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

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

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