Improving cognitive function in older adults after stem cell transplant
Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation
This study is testing if a special exercise program can help older adults who had a stem cell transplant think better and improve their brain health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT04898790 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance cognitive function in older adults who have undergone hematopoietic cell transplantation (HCT) for hematological malignancies. It will adapt and test the Community Health Activities Model Program for Seniors II (CHAMPS II), an evidence-based physical activity intervention, specifically for adults aged 60 and older in the HCT setting. The study will involve semi-structured interviews with patients to assess their experiences and needs related to cognitive health. By increasing physical activity, the study hypothesizes that cognitive function can be improved in this vulnerable population, addressing a significant gap in post-transplant care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 60 years and older who have been diagnosed with a hematological malignancy and have received a stem cell transplant within the past 3-6 months.
Not a fit: Patients who are younger than 60 years or have not undergone a stem cell transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive function and quality of life for older adults recovering from stem cell transplants.
How similar studies have performed: While similar interventions have shown success in improving cognitive function in other cancer populations, this specific approach in older adults undergoing HCT is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Thuy Koll, MD — University of Nebraska
- Study coordinator: Marcia M Free, BSN
- Email: marcia.free@unmc.edu
- Phone: 402-559-8151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.