The Patients' Experience After Stem Cell Transplant
Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study
1 other identifier
observational
110
1 country
1
Brief Summary
This study will examine how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; whether these changes affect day-to-day activities and quality of life and how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. Genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2022
CompletedJanuary 8, 2026
December 1, 2025
5.2 years
January 19, 2018
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.
Cognition will be measured using a neuropsychological battery.
Before transplant; Post Transplant at 100 days, 6 months, and 12 months
Secondary Outcomes (3)
Assess quality of life of of older patients undergoing allogeneic and autologous transplant at 4 timepoints.
Before transplant; Post Transplant at 100 days, 6 months, and 12 months
Assess activity engagement of older patients undergoing allogeneic and autologous transplant at 4 timepoints.
Before transplant; Post Transplant at 100 days, 6 months, and 12 months
Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.
1 time collection: Before transplant
Eligibility Criteria
The study population is being recruited from the Fred \& Pamela Buffett Cancer Center at the University of Nebraska Medical Center.
You may qualify if:
- Between the ages of 60-85
- Diagnosed with a hematological malignancy
- Is considering an autologous or allogeneic stem cell transplant OR has undergone stem cell transplant in the past 12 months and seen by the PI for pre-transplant evaluation.
- Is able to read, write, speak, and understand English
You may not qualify if:
- As per self report or medical record, history of central nervous system involvement and/or history of cranial irradiation or intrathecal chemotherapy except for patients with history of prophylactic intrathecal chemotherapy.
- As per self report or medical record, history of stroke, head injury, neurosurgery, seizure disorder, or demyelinating disorder.
- As per self report or medical record, history of substance use disorder.
- As per self report or in the judgement of the consenting professional, uncorrected vision loss.
- As per self report or medical record, primary psychiatric disorder necessitating inpatient treatment in the last 12 months.
- As per self report or medical record, history of allogeneic and or autologous stem cell transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Biospecimen
A saliva sample will be obtained.
Study Officials
- PRINCIPAL INVESTIGATOR
Thuy Koll, MD
University of Nebraska
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2018
First Posted
March 6, 2018
Study Start
September 1, 2017
Primary Completion
November 11, 2022
Study Completion
November 11, 2022
Last Updated
January 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share