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New treatment option for Leukemia
Official title Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
ClinicalTrials.gov ID: NCT04898790
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Arm 1: 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- Arm 1: 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
What rules you out
- 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 assigned by chance 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...
- 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...
- (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...
- 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...
- 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...
- 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...
- 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...
- age 19 years and older
- able to speak and read English Exclusion Criteria for Transplant Team Member:
- there are no exclusion criteria
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.