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The Patients' Experience After Stem Cell Transplant

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03454568
Enrollment
110
Registered
2018-03-06
Start date
2017-09-01
Completion date
2022-11-11
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Transplant Complications

Keywords

Stem Cell Transplant

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.

Interventions

None listed

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 monthsCognition will be measured using a neuropsychological battery.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026