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

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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Key information

Conditions

Quality of Life Graft vs Host Disease Graft-vs-Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients.

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Sung Choi, M.D.

Other

Registry information

Official study title

Cognitive Function and Patient-Reported Psychological and Functional/Quality of Life Outcomes Investigation in Patients Taking Vorinostat for Graft-versus-Host Disease Prophylaxis

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Apr 6, 2015
Registry last updated: Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed