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NCT02409134 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02409134
Other study ID # UMCC 2015.020
Secondary ID HUM00096406
Status Completed
Phase
First received
Last updated
Start date April 2015
Est. completion date April 2018

Study information
Verified date June 2018
Source University of Michigan Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Health System Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
Sung Choi, M.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients. 3 years
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