Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT04898790

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

Led by University of Nebraska · Updated on 2025-07-23

88

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years and older (Arm 1) or 55 years and older (Arms 2 and 3)
  • Diagnosis of hematological malignancy
  • Received autologous or allogeneic hematopoietic cell transplantation within the prior 3-6 months (Arm 1) or planned to receive HCT (Arms 2 and 3)
  • Able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance) (Arms 2 and 3)
  • Able to speak and read English
  • Provided written informed consent
  • For Arm 3 participants, willingness to be randomized to initiate physical activity intervention either before HCT or after Day 180 post-HCT
  • Care-partners aged 19 years and older, able to speak and read English, able to walk 4 meters (with or without assistance), and medically cleared for light to moderate physical activity
  • Transplant team members aged 19 years and older, able to speak and read English
Not Eligible

You will not qualify if you...

  • Development of chest pain, severe shortness of breath, or other safety concerns during physical performance measures
  • Not cleared to participate in exercise by a physician
  • Medical history requiring cardiologist clearance for exercise, including recent myocardial infarction (past 3 months), unstable angina, uncontrolled arrhythmias, 3rd degree heart block, acute congestive heart failure or ejection fraction <30%, or significant aortic stenosis
  • Medical history requiring surgeon clearance for exercise, including hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
  • Other medical, psychiatric, or behavioral factors that may interfere with participation or ability to follow the intervention or control condition
  • For Arm 3 voluntary biomarker and MRI measures: history of severe traumatic brain injury or brain abnormalities, major stroke with residual deficits, relapsing-remitting multiple sclerosis, or active moderate to severe psychiatric symptoms due to primary psychiatric disorder
  • No exclusion criteria for care-partners or transplant team members beyond the above medical requirements

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

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Research Team

M

Marcia M Free, BSN

CONTACT

T

Thuy Koll, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant | DecenTrialz