Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant (NCT04898790) | Clinical Trial Compass
RecruitingNot Applicable
Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
United States108 participantsStarted 2021-11-18
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Perfor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in executive function as measured by Trails A.
Timeframe: 12 weeks
2
Change in executive function as measured by Trails B.
Timeframe: 12 weeks
3
Change in executive function as measured by the Controlled Oral Word Association Test (COWAT).
Timeframe: 12 weeks
4
Change in working memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).