Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat
2 other identifiers
observational
9
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJune 14, 2018
June 1, 2018
3 years
March 23, 2015
June 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients.
3 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sung Choi, M.D.lead
Study Sites (1)
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Hoodin F, LaLonde L, Errickson J, Votruba K, Kentor R, Gatza E, Reddy P, Choi SW. Cognitive Function and Quality of Life in Vorinostat-Treated Patients after Matched Unrelated Donor Myeloablative Conditioning Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Feb;25(2):343-353. doi: 10.1016/j.bbmt.2018.09.015. Epub 2018 Sep 20.
PMID: 30244099DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 23, 2015
First Posted
April 6, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
June 14, 2018
Record last verified: 2018-06