NCT03454568

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

5.2 years

First QC Date

January 19, 2018

Last Update Submit

January 5, 2026

Conditions

Keywords

Stem Cell Transplant

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

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

A saliva sample will be obtained.

Study Officials

  • Thuy Koll, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

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

Locations