← Back to Search

Physical Activity Intervention for Cognitive Function Post-Stem Cell Transplant (PROACTIVE Trial)

N/A

Recruiting

Led By Thuy Koll, MD

Research Sponsored by Thuy Koll MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Transplant Team Member: age 19 years and older, able to speak and read English

Participants in Arms 2 and 3: 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), 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

PROACTIVE Trial Summary

This trial will adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the hematopoietic cell transplantation (HCT) setting for adults 60 years and older in order to improve cognitive function.

Who is the study for?

This trial is for older adults aged 60+ who have hematological malignancies like lymphoma or leukemia and are undergoing stem cell transplant. They must be able to walk a short distance, speak English, and consent to participate. Care-partners of these patients can also join if they meet similar criteria.Check my eligibility

What is being tested?

The trial tests an adapted physical activity program called CHAMPS-II, designed to improve cognitive function in seniors post-stem cell transplant. Participants will engage in light to moderate exercises until Day 100 post-transplant compared with a wait-list control group.See study design

What are the potential side effects?

Since the intervention involves physical activity, potential side effects may include typical exercise-related issues such as muscle soreness or fatigue. However, participants with severe reactions during initial assessments or those not cleared by physicians are excluded.

PROACTIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 19 or older and can speak and read English.

Select...

I am 60 or older, diagnosed with blood cancer, and can walk 4 meters. I agree to follow the study's physical activity plan.

Select...

I am 60 or older, had a stem cell transplant in the last 3-6 months for blood cancer, and can speak English.

Select...

My care-partner is 19 or older and speaks English.

Select...

My care-partner is 19 or older, speaks English, can walk 4 meters, and is cleared for light to moderate exercise.

PROACTIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in executive function as measured by Trails A.

Change in executive function as measured by Trails B.

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

+1 more

Secondary outcome measures

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

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

Other outcome measures

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

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

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

+2 more

PROACTIVE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adapted CHAMPS-II interventionExperimental Treatment1 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).

Group II: Feedback for Preliminary AdaptationActive Control1 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thuy Koll MDLead Sponsor

University of NebraskaLead Sponsor

538 Previous Clinical Trials

1,144,466 Total Patients Enrolled

12 Trials studying Leukemia

1,000,517 Patients Enrolled for Leukemia

Thuy Koll, MDPrincipal InvestigatorUniversity of Nebraska

1 Previous Clinical Trials

110 Total Patients Enrolled

Media Library

CHAMPS-II adapted to adults 60+ years in HCT setting Clinical Trial Eligibility Overview. Trial Name: NCT04898790 — N/A

Leukemia Research Study Groups: Adapted CHAMPS-II intervention, Feedback for Preliminary Adaptation

Leukemia Clinical Trial 2023: CHAMPS-II adapted to adults 60+ years in HCT setting Highlights & Side Effects. Trial Name: NCT04898790 — N/A

CHAMPS-II adapted to adults 60+ years in HCT setting 2023 Treatment Timeline for Medical Study. Trial Name: NCT04898790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor still have opportunities for enrollment?

"Affirmative. The information on clinicaltrials.gov demonstrates that this experiment is actively looking for participants, having first been posted on November 18th 2021 and last updated November 26th 2021. 90 individuals are needed to be enrolled at one medical facility."

Answered by AI

What goals are being sought to be achieved through this experiment?

"The primary objective of this 12-week trial is to assess improvement in executive function as determined by COWAT. Secondary goals include evaluating changes in global cognitive ability with MoCA, subjective memory through Neuro-QOL Cognition Function Short Form, and overall cognition assessed using Montreal Cognitive Assessment (MoCA)."

Answered by AI

How many participants are being given treatment as part of this clinical experiment?

"Affirmative. The clinicaltrials.gov database states that this medical research, initially posted on November 18th 2021, is currently attempting to enrol patients. 90 participants must be recruited from 1 location for the trial to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

Thuy Koll MD 2021. "Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04898790.

All > Leukemia