NCT04898790 · University of Nebraska
Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
(PROACTIVE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
CHAMPS-II adapted to adults 60+ years in HCT setting
CHAMPS-II is an evidence-based physical activity program designed to increase physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. Participants will engage in progressive, light to moderate-intensity physical activity throughout the HCT process, with the support of physical therapists, physical activity counselors, and their care-partner. They will take part in supervised exercise sessions; unsupervised exercise sessions; counseling sessions to address barriers, motivators, goals, and safety; and receive telephone support. Walking is the primary mode of aerobic activity, with training in flexibility, strengthening and balance exercises also included. An exercise kit will be provided, consisting of an intervention workbook, therapeutic resistance bands, and activity logs.
Primary outcome measures
Change in executive function as measured by Trails A.
Time frame: 12 weeks
Change in raw scores and z-scores, determined by the following neuropsychological test: Trail Making Test Part A (Trails A). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Change in executive function as measured by Trails B.
Time frame: 12 weeks
Change in raw scores and z-scores, determined by the following neuropsychological tests: Trail Making Test Part B (Trails B). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Change in executive function as measured by the Controlled Oral Word Association Test (COWAT).
Time frame: 12 weeks
Change in raw scores and z-scores, determined by the following neuropsychological test: Controlled Oral Word Association Test (COWAT). Minimum score is zero and maximum is unlimited; higher score means better outcome.
Change in working memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Time frame: 12 weeks
Change in raw scores and z-scores, determined by the following neuropsychological test: Hopkins Verbal Learning Test-Revised (HVLT-R). There are 3 learning trials and 1 delayed recall trial. Minimum score for each is zero and maximum is 12; higher score means better outcome. There is also a delayed recognition trial where person is presented with both true positives and false positives. Minimum score for both is zero and maximum is 12. For the true positives a higher score means better outcome. For the false positives a lower score means better outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Omaha, Nebraska
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2025 · Source of record for eligibility and locations