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CompletedNCT03454568Updated Jan 8, 2026

The Patients' Experience After Stem Cell Transplant

An observational study in Stem Cell Transplant Complications, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by University of Nebraska · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
60 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

In this study, the investigators are looking to understand: 1) how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; 2) whether these changes affect day-to-day activities and quality of life; and 3) 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. Participants will undergo neurocognitive testing along with the collection of a saliva sample and completing a battery of questionnaires and assessments.

02

Conditions studied

  • Stem Cell Transplant Complications

Keywords

  • Stem Cell Transplant
03

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population is being recruited from the Fred \& Pamela Buffett Cancer Center at the University of Nebraska Medical Center.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

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.

    Time frame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months

Secondary outcomes

  1. Assess quality of life of of older patients undergoing allogeneic and autologous transplant at 4 timepoints.

    Quality of life will be measured with the EORTC Quality of Life-30C questionnaire.

    Time frame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months

  2. Assess activity engagement of older patients undergoing allogeneic and autologous transplant at 4 timepoints.

    Activity engagement will be measured with the Activity Card Sort-modified.

    Time frame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months

  3. Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.

    A saliva sample will be collected to look at genetic variations.

    Time frame: 1 time collection: Before transplant

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Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
07

References and documents

Study documents

  • Informed consent form · May 8, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03454568
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Sep 1, 2017
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Last update
Jan 8, 2026

Study contacts

Thuy Koll, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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