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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
Be older than 18 years old
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 moreSecondary 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 morePROACTIVE 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.
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Who is running the clinical trial?
Thuy Koll MDLead Sponsor
University of NebraskaLead Sponsor
541 Previous Clinical Trials
1,144,665 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You experience chest pain, severe shortness of breath, or any other safety concerns during physical activities, and have not been cleared by a doctor to exercise. You have medical, psychiatric, or behavioral factors that may interfere with participating in the study or following the study's requirements.I am 19 or older and can speak and read English.I am 60 or older, diagnosed with blood cancer, and can walk 4 meters. I agree to follow the study's physical activity plan.I am 60 or older, had a stem cell transplant in the last 3-6 months for blood cancer, and can speak English.My care-partner is not cleared for exercise due to health concerns or has conditions that interfere with study participation.My care-partner is 19 or older and speaks English.My care-partner is 19 or older, speaks English, can walk 4 meters, and is cleared for light to moderate exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Adapted CHAMPS-II intervention
- Group 2: Feedback for Preliminary Adaptation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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