The Patients' Experience After Stem Cell Transplant | NCT03454568

Studies
The Patients' Experience After Stem Cell Transplant

NCT03454568

Sponsor

University of Nebraska

Status

Completed

Last Update Posted

Jan 8, 2026Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Stem Cell Transplant Complications

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Nov 11, 2022Actual

Completion Date

Nov 11, 2022Actual

First Submitted Date

Jan 19, 2018

First Submission Date that Met QC Criteria

Mar 2, 2018

First Posted Date

Mar 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2026

Last Update Posted Date

Jan 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Thuy Koll, MD	University of Nebraska	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided