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OpenTrials
Completed

NCT Number: NCT03454568

The Patients' Experience After Stem Cell Transplant

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Assess quality of life of of older patients undergoing allogeneic and autologous transplant at 4 timepoints.

    Time frame: 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.

  2. Assess activity engagement of older patients undergoing allogeneic and autologous transplant at 4 timepoints.

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

    Activity engagement will be measured with the Activity Card Sort-modified.

  3. Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.

    Time frame: 1 time collection: Before transplant

    A saliva sample will be collected to look at genetic variations.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2018
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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