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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02409134
Enrollment
9
Registered
2015-04-06
Start date
2015-04-30
Completion date
2018-04-30
Last updated
2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-vs-Host Disease, Quality of Life

Keywords

Bone Marrow Transplantation, Hematologic Malignancies, Adults, Cognition

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 .

Interventions

None listed

Sponsors

Sung Choi, M.D.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients.3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026