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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

• age 19 years and older

• able to speak and read English

• age 19 years and older

• able to speak and read English

• 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

• 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

• age 19 years and older

• able to speak and read English

Locations
United States
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Marcia M Free, BSN
marcia.free@unmc.edu
402-559-8151
Backup
Thuy Koll, MD
thuy.koll@unmc.edu
402-559-7519
Time Frame
Start Date: 2021-11-18
Estimated Completion Date: 2027-07
Participants
Target number of participants: 88
Treatments
No_intervention: Feedback for Preliminary Adaptation
Participants in Aim 1 will participate in qualitative interviews to obtain feedback on the CHAMPS-II intervention and survivorship education active control condition materials. Interviews will be with 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members.
Experimental: Adapted CHAMPS-II intervention
All participants in Aim 2 (preliminary testing) and Aim 3 (RCT) will participate in the CHAMPS-II physical activity program adapted to the HCT setting. Testing for outcome measures will be completed, and feedback on the intervention will be obtained via qualitative interviews from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members.~Aim 3 participants will be randomized to either the immediate intervention (intervention then follow-up) or delayed intervention (wait period and then intervention).
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov