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

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.

Study Overview

• Status: Completed
• Conditions: Stem Cell Transplant Complications

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• 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.

Description

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:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Activity engagement will be measured with the Activity Card Sort-modified.	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.	A saliva sample will be collected to look at genetic variations.	1 time collection: Before transplant

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Thuy Koll, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stem Cell Transplant
• Other Study ID Numbers: 0431-17-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No