Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT04898790
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHAMPS-II adapted to adults 60+ years in HCT setting — BEHAVIORAL
    CHAMPS-II is an evidence-based physical activity program designed to increase physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. Participants will engage in progressive, light to moderate-intensity physical activity throughout the HCT process, with the support of physical therapists, physical activity counselors, and their care-partner. They will take part in supervised exercise sessions; unsupervised exercise sessions; counseling sessions to address barriers, motivators, goals, and safety; and receive telephone support. Walking is the primary mode of aerobic activity, with training in flexibility, strengthening and balance exercises also included. An exercise kit will be provided, consisting of an intervention workbook, therapeutic resistance bands, and activity logs.

Study Details

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.

Key Dates

Start date
Nov 18, 2021
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Change in executive function as measured by Trails A. [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Thuy Koll, MD
[email protected]
402-559-7519
Marcia M Free, RN
[email protected]
402-559-8151
Thuy Koll, MD (PRINCIPAL_INVESTIGATOR)

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