Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat
- Conditions
- Quality of LifeGraft-vs-Host Disease
- Registration Number
- NCT02409134
- Lead Sponsor
- Sung Choi, M.D.
- Brief Summary
Psychological well-being and cognitive function will be measured in patients enrolled on the primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation. Validated questionnaires will be administered to assess patients' level of depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality. Cognitive testing will include reliable and valid measures of processing speed, attention, executive function, episodic memory, and visual learning and memory. The purpose of this study is to determine whether these measures are feasible to administer in patients before and at early time points after bone marrow transplantation .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Patients must be enrolled on the parent study (NCT01790568; A phase 2 clinical trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation)
- Must speak, read and understand English
- Documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients. 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States