The Patients' Experience After Stem Cell Transplant

NCT ID: NCT03454568

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-11-11

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.

Conditions

Stem Cell Transplant Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thuy Koll, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

0431-17-EP

Identifier Type: -

Identifier Source: org_study_id