[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation


Description

Cancer and treatment-related cognitive changes 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. Physical activity improves cognitive function in older adults and survivors of other cancers. We hypothesize that increasing physical activity can also improve cognitive function in this vulnerable population. The objective of this research 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 60 years and older. Aim 1: Adapt the CHAMPS-II manual and develop study materials using feedback from up to 10 patient/care-partner dyads who have experienced the HCT process within the last 3-6 months and HCT team members via semi-structured interviews. Aim 2: Iteratively adapt and implement CHAMPS-II intervention in three waves (2-6 patient/care-part

Trial Eligibility

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 60 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: 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 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

Study Info

Organization

University of Nebraska


Primary Outcome

Change in executive function as measured by Trails A.


Outcome Timeframe 12 weeks

NCTID NCT04898790

Phases NA

Primary Purpose TREATMENT

Start Date 2021-11-18

Completion Date 2026-06

Enrollment Target 88

Interventions

BEHAVIORAL CHAMPS-II adapted to adults 60+ years in HCT setting

Locations Recruiting

University of Nebraska Medical Center

United States, Nebraska, Omaha


Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.

newsletter icon

Get the latest thought leadership on your Lymphoma delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.