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Behavioral and Neural Indices of Cognitive Rehabilitation in Ovarian Cancer: A Pilot Study


N/A
21 Years
90 Years
Open (Enrolling)
Female
Cancer Survivor, Cognitive/Functional Effects, Ovarian Neoplasm

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Trial Information

Behavioral and Neural Indices of Cognitive Rehabilitation in Ovarian Cancer: A Pilot Study


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 ovarian 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: Patients participate in a memory and thinking skills workshop once weekly for 8
weeks. Patients complete cognitive tests and questionnaires at baseline and 7 weeks.

ARM II: Patients complete cognitive tests and questionnaires at baseline and 7 weeks.
Patients are then scheduled to participate in a later memory and thinking skills workshop.


Inclusion Criteria:



- Subjective concern about declines in cognitive functioning related to a diagnosis of
cancer and/or cancer related treatment

- Prior treatment of ovarian cancer with chemotherapy

- Completion of treatment (e.g., chemotherapy, radiation therapy, surgery, etc.) for
ovarian 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 are not

- 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

- Current substance use or abuse as defined by any recreational drug use (e.g. cocaine,
methamphetamine, crack, hashish, heroin, acid, mushrooms and others that may not be
listed here but are determined to be adverse according to PI) as well as any use of
marijuana regardless of medical prescription

- 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 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)

- A score above 45 on the Wender Utah Rating Scale for 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Changes in cognitive performance and QOL pre and post participation in a cognitive rehabilitation intervention

Outcome Description:

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.

Outcome Time Frame:

Baseline to 7 weeks

Safety Issue:

No

Principal Investigator

Heidi Gray

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

7750

NCT ID:

NCT01641068

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Cancer Survivor
  • Cognitive/Functional Effects
  • Ovarian Neoplasm
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109