The Patients' Experience After Stem Cell Transplant

Stem Cell Transplant Complications Clinical Trial

Official title:

Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454568
• Other study ID #: 0431-17-EP
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: November 11, 2022

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 60-85

2. Diagnosed with a hematological malignancy

3. 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.

4. Is able to read, write, speak, and understand English

Exclusion Criteria:

1. 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.

2. As per self report or medical record, history of stroke, head injury, neurosurgery, seizure disorder, or demyelinating disorder.

3. As per self report or medical record, history of substance use disorder.

4. As per self report or in the judgement of the consenting professional, uncorrected vision loss.

5. As per self report or medical record, primary psychiatric disorder necessitating inpatient treatment in the last 12 months.

6. As per self report or medical record, history of allogeneic and or autologous stem cell transplant.

Related Conditions & MeSH terms

• Stem Cell Transplant Complications

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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