Clinical trial NCT03454568: The Patients' Experience After Stem Cell Transplant
Official title: Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplant Complications
Keywords: Stem Cell Transplant
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is being recruited from the Fred \& Pamela Buffett Cancer Center at the University of Nebraska Medical Center.

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.

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.

Primary outcomes:
measure: Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.
timeFrame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months
Secondary outcomes:
measure: Assess quality of life of of older patients undergoing allogeneic and autologous transplant at 4 timepoints.
timeFrame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months
measure: Assess activity engagement of older patients undergoing allogeneic and autologous transplant at 4 timepoints.
timeFrame: Before transplant; Post Transplant at 100 days, 6 months, and 12 months
measure: Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.
timeFrame: 1 time collection: Before transplant
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thuy Koll, MD
role: PRINCIPAL_INVESTIGATOR
References: