The Patients' Experience After Stem Cell Transplant

Sponsor
University of Nebraska (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03454568
Collaborator
(none)
110
1
105.9
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants will undergo neurocognitive testing along with the collection of a saliva sample and completing a battery of questionnaires and assessments.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study
    Actual Study Start Date :
    Sep 1, 2017
    Anticipated Primary Completion Date :
    Nov 30, 2022
    Anticipated Study Completion Date :
    Jun 30, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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 months]

      Cognition will be measured using a neuropsychological battery.

    Secondary Outcome Measures

    1. 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]

      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. [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. [1 time collection: Before transplant]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Nebraska Medical Center Omaha Nebraska United States 68198

    Sponsors and Collaborators

    • University of Nebraska

    Investigators

    • Principal Investigator: Thuy Koll, MD, University of Nebraska

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thuy Koll MD, Assistant Professor-Division of Geriatrics, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT03454568
    Other Study ID Numbers:
    • 431-17-EP
    First Posted:
    Mar 6, 2018
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Thuy Koll MD, Assistant Professor-Division of Geriatrics, University of Nebraska

    Study Results

    No Results Posted as of Mar 10, 2022