88 Participants Needed

Physical Activity Intervention for Cognitive Function Post-Stem Cell Transplant

(PROACTIVE Trial)

MF
TK
MM
Overseen ByMarcia M Free, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thuy Koll MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is physical activity intervention safe for people after stem cell transplant?

Exercise interventions for people undergoing stem cell transplants have generally been safe, with no adverse events directly linked to the exercise programs in the studies reviewed. However, one serious adverse event occurred during a baseline test, not related to the exercise intervention itself, suggesting that while exercise is generally safe, individual health conditions should be considered.12345

How is the CHAMPS-II treatment different from other treatments for cognitive function post-stem cell transplant?

The CHAMPS-II treatment is unique because it focuses on a physical activity intervention specifically adapted for older adults (60+ years) who have undergone stem cell transplants, aiming to improve cognitive function. Unlike other treatments that may not emphasize exercise, this program is designed to enhance physical activity levels, which can help improve overall quality of life and cognitive health in this specific patient group.24678

What data supports the effectiveness of the treatment CHAMPS-II adapted to adults 60+ years in HCT setting?

Exercise interventions have shown preliminary success in maintaining physical function in patients undergoing hematopoietic cell transplantation (HCT), suggesting that physical activity can be beneficial in this context.13458

Who Is on the Research Team?

TK

Thuy Koll, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.
My care-partner is not cleared for exercise due to health concerns or has conditions that interfere with study participation.
Transplant Team Member: no exclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preliminary Adaptation

Participants provide feedback on the CHAMPS-II intervention and survivorship education materials through qualitative interviews.

3-6 months
Interviews with participants, care-partners, and HCT team members

Treatment

Participants engage in the adapted CHAMPS-II physical activity program to improve cognitive function.

12 weeks
Regular sessions as per CHAMPS-II program

Follow-up

Participants are monitored for changes in cognitive function and physical activity outcomes.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CHAMPS-II adapted to adults 60+ years in HCT setting
  • Survivorship education active control
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Adapted CHAMPS-II interventionExperimental Treatment1 Intervention
Group II: Feedback for Preliminary AdaptationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thuy Koll MD

Lead Sponsor

Trials
1
Recruited
90+

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Published Research Related to This Trial

In a study of 47 adult patients who underwent allogeneic hematopoietic cell transplantation (HCT), physical function was assessed before and after the procedure, revealing that patients were largely sedentary, spending a median of 6 hours daily inactive post-transplant.
The 6-minute walk test (6MWT) conducted on day +30 post-HCT was strongly associated with survival outcomes, indicating that early physical function assessments can help predict long-term mortality risks in HCT recipients.
Objective and subjective physical function in allogeneic hematopoietic stem cell transplant recipients.Mishra, A., Pidala, J., Thapa, R., et al.[2023]
Eighteen adolescent and young adult patients undergoing hematopoietic stem cell transplant engaged in exercise during hospitalization, averaging 76% of days and 36.5 minutes per day, primarily using standard activities like walking and resistance training.
Despite high participation rates in exercise, there were no improvements in functional capacity or quality of life, indicating that supervision and structured programs may be necessary to enhance the benefits of exercise for these patients.
Assessment of voluntary exercise behavior and active video gaming among adolescent and young adult patients during hematopoietic stem cell transplantation.Rosipal, NC., Mingle, L., Smith, J., et al.[2013]
A study of 81 hematopoietic cell transplantation (HCT) survivors found that 83% did not meet the American Cancer Society's recommendation of over 500 MET minutes of physical activity per week, indicating a significant gap in adherence to physical activity guidelines.
Only 17.3% of participants met the recommended activity levels, highlighting the need for improved screening and counseling in HCT survivorship care to promote a more active lifestyle.
Physical Activity Compliance to American Cancer Society Recommendations Amongst Hematopoietic Stem Cell Transplant Survivors.Mead, LE., Kelly, DL., Dahl, WJ., et al.[2023]

Citations

Objective and subjective physical function in allogeneic hematopoietic stem cell transplant recipients. [2023]
Assessment of voluntary exercise behavior and active video gaming among adolescent and young adult patients during hematopoietic stem cell transplantation. [2013]
Physical Activity Compliance to American Cancer Society Recommendations Amongst Hematopoietic Stem Cell Transplant Survivors. [2023]
Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation. [2021]
Physical Activity and Sleep Measures Using a Fitness Tracking Device during Hematopoietic Cell Transplantation: A Pilot Study. [2021]
Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. [2020]
Steps to Enhance Early Recovery After Hematopoietic Stem Cell Transplantation: Lessons Learned From a Physical Activity Feasibility Study. [2018]
A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. [2009]
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