Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 19 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a physical activity program can help older adults with blood cancer think and remember better around a stem cell transplant. It also looks at how brain changes linked to Alzheimer's disease and inflammation may affect thinking and memory. Depending on the study group, patients must be at least 55 or 60 years old.
Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population. The study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners. The second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- All participants must be able to speak and read English. Patients must give written consent to join.
- Group 1 patients: Age 60 or older, with blood cancer, and had a stem cell transplant 3 to 6 months ago.
- Groups 2 and 3 patients: Age 55 or older, with blood cancer, and planning a stem cell transplant.
- The transplant may use the patient's own stem cells or cells from a donor.
- Groups 2 and 3 patients: Must be able to walk 4 meters, about 13 feet, with or without help.
- Group 3 patients: Must agree to be assigned by chance to start the activity program before transplant or after day 180 following transplant, and follow that group's plan.
- Care partners: Age 19 or older. In Groups 2 and 3, they must also walk 4 meters with or without help and be judged able to safely do light to moderate activity.
- Transplant team members: Age 19 or older.
Who can't join
- Group 1 and transplant team members: No exclusion rules are listed.
- Groups 2 and 3 patients and care partners: Chest pain, severe trouble breathing, or other safety concerns during physical tests, or no doctor's approval to exercise.
- Groups 2 and 3 patients and care partners need heart doctor approval for a heart attack in the past 3 months, chest pain at rest or unstable chest pain, serious or uncontrolled heart rhythm problems, a severe block in the heart's electrical signals, sudden heart failure, very weak heart pumping, or major narrowing of the aortic heart valve.
- Groups 2 and 3 patients and care partners need surgeon approval after a hip fracture, hip or knee replacement, or spine surgery in the past 3 months.
- Groups 2 and 3 patients and care partners: Other health, mental health, or behavior issues that the study leader believes would prevent taking part or following the study plan.
- For Group 3's optional blood, saliva, and MRI tests: Lasting brain damage from a past severe head injury, or major problems on a recent brain scan, such as brain cancer, a large stroke, or blood left around the brain.
- For Group 3's optional tests: A major stroke with clear lasting problems, or multiple sclerosis that comes and goes—a disease that harms nerves.
- For Group 3's optional tests: Current moderate to severe symptoms from a mental health disorder.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Arm 1: Inclusion Criteria for Participants: * age 60 years and older * have a diagnosis of hematological malignancy * have received autologous or allogeneic HCT within the prior 3-6 months * able to speak and read English * have provided written informed consent Exclusion Criteria for Participants: * there are no exclusion criteria Inclusion Criteria for Participants' Care-Partner: * age 19 years and older * able to speak and read English Exclusion Criteria for Participants' Care-Partner: * there are no exclusion criteria Inclusion Criteria for Transplant Team Member: * age 19 years and older * able to speak and read English Exclusion Criteria for Transplant Team Member: * there are no exclusion criteria Arms 2 and 3: Inclusion Criteria for Participants: * age 55 years and older * have a diagnosis of hematological malignancy * planned to receive an autologous or allogeneic HCT * able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance) * (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned * able to speak and read English * have provided written informed consent Exclusion Criteria for Participants: * development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery) * is not cleared to participate in exercise by a physician Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist: * Myocardial infarctions in the past 3 months * Resting or unstable angina * Uncontrolled and/or serious arrhythmias * 3rd degree heart block * Acute congestive heart failure or ejection fraction \<30% * Clinically significant aortic stenosis Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon: * Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months * other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition * (In Arm 3 for those who agree to the voluntary measures of blood, saliva and MRI, there are additional exclusions to avoid conditions that may confound study outcomes): * history of residual brain abnormalities from prior severe traumatic brain injury (e.g. encephalomalacia) or other significant abnormalities documented on a recent brain MRI (e.g. brain cancer, large vessel strokes, residual subdural hematoma) * history of major stroke with obvious residual deficits * history of relapsing and remitting Multiple Sclerosis * active moderate to severe psychiatric symptoms due to primary psychiatric disorder Inclusion Criteria for Participants' Care-Partner: * age 19 years and older * able to speak and read English * able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance) * have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form Exclusion Criteria for Participants' Care-Partner: * development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery) * is not cleared to participate in exercise by a physician Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist: * Myocardial infarctions in the past 3 months * Resting or unstable angina * Uncontrolled and/or serious arrhythmias * 3rd degree heart block * Acute congestive heart failure or ejection fraction \<30% * Clinically significant aortic stenosis Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon: o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months * other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition Inclusion Criteria for Transplant Team Member: * age 19 years and older * able to speak and read English Exclusion Criteria for Transplant Team Member: * there are no exclusion criteria
Study sites (1)
NE
- University of Nebraska Medical Center · Omaha, NE 68198Thuy Koll, MD · Study contact · 402-559-7519 · thuy.koll@unmc.eduMarcia M Free, RN · Study contact · 402-559-8151 · marcia.free@unmc.eduThuy Koll, MD · Principal investigatorMore trials in Omaha