Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat

Sung Choi, M.D.

Status: Completed

Conditions: Quality of Life; Graft-vs-Host Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02409134

HUM00096406 (Other Identifier)

UMCC 2015.020

Details and patient eligibility

About

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 .

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).