Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

NCT04898790 | Recruiting DMC

• 1 other identifier: 0421-21-EP
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Myelodysplastic Syndromes (MDS); Myeloproliferative Neoplasm

Keywords

Hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (4)

• Change in executive function as measured by Trails A.

  Change in raw scores and z-scores, determined by the following neuropsychological test: Trail Making Test Part A (Trails A). Time to complete and number of errors are measured, where less time and errors are better outcomes.

  12 weeks

• Change in executive function as measured by Trails B.

  Change in raw scores and z-scores, determined by the following neuropsychological tests: Trail Making Test Part B (Trails B). Time to complete and number of errors are measured, where less time and errors are better outcomes.

  12 weeks

• Change in executive function as measured by the Controlled Oral Word Association Test (COWAT).

  Change in raw scores and z-scores, determined by the following neuropsychological test: Controlled Oral Word Association Test (COWAT). Minimum score is zero and maximum is unlimited; higher score means better outcome.

  12 weeks

• Change in working memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).

  Change in raw scores and z-scores, determined by the following neuropsychological test: Hopkins Verbal Learning Test-Revised (HVLT-R). There are 3 learning trials and 1 delayed recall trial. Minimum score for each is zero and maximum is 12; higher score means better outcome. There is also a delayed recognition trial where person is presented with both true positives and false positives. Minimum score for both is zero and maximum is 12. For the true positives a higher score means better outcome. For the false positives a lower score means better outcome.

  12 weeks

Secondary Outcomes (2)

• Change in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA).

  12 weeks

• Change in subjective memory as measured by the Neuro-Quality of Life (QOL) Cognition Function-Short Form.

  12 weeks

Other Outcomes (9)

• Change in functional ability as measured by the Short Performance Physical Battery (SPPB).

  12 weeks

• Change in endurance as measured by the 6-minute walk.

  12 weeks

• Change in performance of instrumental activities of daily living as measured by the Lawton Instrumental Activities of Daily Living (IADL).

  12 weeks

Study Arms (2)

Feedback for Preliminary Adaptation

NO INTERVENTION

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.

Adapted CHAMPS-II intervention

EXPERIMENTAL

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).

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

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.

Adapted CHAMPS-II intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age 19 years and older
• able to speak and read English
• age 19 years and older
• able to speak and read English
• Arms 2 and 3:
• 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
• 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:

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Myelodysplastic Syndromes; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases

Study Officials

• Thuy Koll, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia M Free, BSN

CONTACT

402-559-8151; marcia.free@unmc.edu

Thuy Koll, MD

CONTACT

402-559-7519; thuy.koll@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor completing primary outcome testing during the RCT in Aim 3 will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 1 will seek feedback from 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members for preliminary adaptation of the evidence-based physical activity intervention (CHAMPS-II) manual, and development of study materials. Aim 2 will iteratively adapt and implement CHAMPS-II for adults 60 years and older undergoing HCT with feedback from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 will take the final CHAMPS-II adaptation from Aim 2 and pilot test it, using a Type 1 hybrid effectiveness-implementation design to determine its preliminary effectiveness to improve cognitive function compared to a wait-list control condition. Feedback will be obtained on the intervention and control condition from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 24, 2021
• Study Start: November 18, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)