Stem Cell Transplant ComplicationsNCT03454568
The Patients' Experience After Stem Cell Transplant
An observational study of Stem Cell Transplant Complications, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Stem Cell Transplant Complications
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 11 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is being recruited from the Fred \& Pamela Buffett Cancer Center at the University of Nebraska Medical Center.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study
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.
Read the 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.
- Conditions
- Stem Cell Transplant Complications
- Keywords
- Stem Cell Transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.
Cognition will be measured using a neuropsychological battery.
Measured: Before transplant; Post Transplant at 100 days, 6 months, and 12 months
Secondary outcomes (3)
Assess quality of life of of older patients undergoing allogeneic and autologous transplant at 4 timepoints.
Quality of life will be measured with the EORTC Quality of Life-30C questionnaire.
Measured: Before transplant; Post Transplant at 100 days, 6 months, and 12 months
Assess activity engagement of older patients undergoing allogeneic and autologous transplant at 4 timepoints.
Activity engagement will be measured with the Activity Card Sort-modified.
Measured: 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.
A saliva sample will be collected to look at genetic variations.
Measured: 1 time collection: Before transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Sep 2017
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thuy Koll, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454568
- Sponsor's protocol ID
- 0431-17-EP
- Status last verified
- Dec 2025
- First submitted
- 19 Jan 2018
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03454568
- Acronym / sponsor ID
- 0431-17-EP
- Conditions
- Stem Cell Transplant Complications
- Keywords
- Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is being recruited from the Fred \& Pamela Buffett Cancer Center at the University of Nebraska Medical Center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
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
Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.
Time frame: 1 time collection: Before transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Stem Cell Transplant Complications
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thuy Koll, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.