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

NCT01641068 | Completed

• 3 other identifiers: 7750NCI-2012-01035P30CA015704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Cancer Survivor; Cognitive Side Effects of Cancer Therapy; Malignant Female Reproductive System Neoplasm

Keywords

Memory; Attention; Chemo-brain; Survivor; Treatment

Outcome Measures

Primary Outcomes (3)

• 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.

  Pre-workshop to 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.

  Pre-workshop to 7 weeks post-workshop

• Changes in neural function measured by fMRI BOLD signal

  MRI functional imaging assessments while performing cognitive tasks.

  Pre-workshop to 7 weeks post-workshop

Study Arms (2)

Arm I (memory and thinking skills workshop)

EXPERIMENTAL

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: Cognitive Intervention; Procedure: Functional Magnetic Resonance Imaging; Other: Memory Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (Education Workshop)

ACTIVE COMPARATOR

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: Educational Intervention; Procedure: Functional Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cognitive Intervention OTHER

Participate in memory and thinking skills workshop

Arm I (memory and thinking skills workshop)

Educational Intervention OTHER

Participate in workshops focusing on increasing knowledge and education on the brain and cognition

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (Education Workshop)

Functional Magnetic Resonance Imaging PROCEDURE

Undergo functional neuroimaging

Also known as: fMRI, FUNCTIONAL MRI

Arm I (memory and thinking skills workshop); Arm II (Education Workshop)

Memory Intervention OTHER

Participate in memory and thinking skills workshop

Arm I (memory and thinking skills workshop)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (memory and thinking skills workshop); Arm II (Education Workshop)

Questionnaire Administration OTHER

Ancillary studies

Arm I (memory and thinking skills workshop); Arm II (Education Workshop)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Heidi Gray

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: September 12, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

US (1)