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Clinical Trials/NCT03454568
NCT03454568
Completed
N/A

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

University of Nebraska1 site in 1 country110 target enrollmentSeptember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stem Cell Transplant Complications
Sponsor
University of Nebraska
Enrollment
110
Locations
1
Primary Endpoint
Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
November 11, 2022
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.

Time Frame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months

Cognition will be measured using a neuropsychological battery.

Secondary Outcomes

  • 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)
  • 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)
  • Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.(1 time collection: Before transplant)

Study Sites (1)

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