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

What's the purpose of this trial?

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-partner dyads per wave). The dyads will participate in a multi-phase, light to moderate-intensity physical activity program through Day 100 post-HCT. Aim 3: Test the preliminary effectiveness of the adapted intervention to improve cognitive function compared to a wait-list control condition (N = 34 per group) in a 2-arm, pilot randomized controlled trial. Primary and secondary outcomes will include subjective and objective cognitive function using a short battery of neuropsychological tests and a self-report questionnaire. Tertiary outcomes comprise subjective and objective measures of physical activity behavior and physical function. The RE-AIM framework will be utilized for formative and process evaluation during the adaptation process and implementation of the intervention.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Observational Trial

Enrollment: 88 patients (estimated)

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Trial Locations

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Nebraska

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