The Patients' Experience After Stem Cell Transplant

Completed

• Conditions: Stem Cell Transplant Complications

• Registration Number: NCT03454568
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-06
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.	Before transplant; Post Transplant at 100 days, 6 months, and 12 months	Cognition will be measured using a neuropsychological battery.

Secondary Outcome Measures

Name	Time	Method
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	Activity engagement will be measured with the Activity Card Sort-modified.
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	Quality of life will be measured with the EORTC Quality of Life-30C questionnaire.
Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.	1 time collection: Before transplant	A saliva sample will be collected to look at genetic variations.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States