Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat
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ClinicalTrials.gov Identifier: NCT02409134
Recruitment Status :
First Posted : April 6, 2015
Last Update Posted : June 14, 2018
Sung Choi, M.D.
Information provided by (Responsible Party):
Sung Choi, M.D., University of Michigan Rogel Cancer Center
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 .
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients enrolled on the primary study NCT01790568. Eligible patients who choose not to participate in this add-on study will not be excluded from participating in NCT01790568.
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).