ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant Patients

This study is testing a behavioral intervention called ACTivate sessions for people undergoing stem cell transplants. ACTivate sessions use Acceptance and Commitment Therapy (ACT) to help you and your caregivers stick to recommendations for physical activity and nutrition, even when facing challenges like side effects. The study aims to see if these sessions can improve your physical function, measured by how far you can walk in six minutes. You may be able to join if you are between 18 and 80 years old, are planning to have an allogeneic (donor) stem cell transplant, and are willing to follow study procedures. The current status of this study is unclear, and it plans to enroll 476 participants.

Study design
This is a Phase 2, multicenter, randomized controlled trial. It will compare the ACTivate sessions to a control group.
What's involved
You would need to be available for the duration of the study and willing to comply with all study procedures and lifestyle considerations. The primary endpoint is measured at baseline and Day 30.
Compensation
Not stated in the trial record.
Follow-up
Physical function is measured at baseline and Day 30 after the intervention.

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NCT07516314

ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant Patients

Not Yet Recruiting
NAAges 18–80InterventionalSupportive care
Anthony Sung, MD
~476 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:ACTivate sessions

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Physical Function (Six Minute Walk Test Distance)
Measured over Baseline, Day 30
Stem Cell Transplant Patients
2 sites across 2 states
Kansas1
North Carolina1

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Eligibility criteria

Inclusion

Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote / electronic consent via REDCap consenting allowed per IRB policy and approval.
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
Plan to undergo allogeneic HCT in approximately 30 days
Males and/or females age 18 - 80 years
Agreement to adhere to Lifestyle Considerations throughout study duration
Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). NOTE: A smartphone will be provided to participants if needed.
Able to read/write English or Spanish (as we lack trained ACT interventionists in other languages)
Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote / electronic consent via REDCap consenting allowed per IRB policy and approval.
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
Males and/or females age 18-80 years
Agreement to adhere to Lifestyle Considerations throughout study duration
Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). NOTE: A smartphone will be provided to participants if needed.
Able to read/write English or Spanish (as we lack trained ACT interventionists in other languages)

Exclusion

Caregiver unwilling to enroll (as standard of care, all HCT patients are required to have a caregiver, but caregivers may decline to participate in this study which would make the patient ineligible for this study)
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Concurrent participation in another behavioral intervention research study.
Activity restrictions that limit one's ability to engage in intense physical activity
Patient unwilling to enroll
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Activity restrictions that limit one's ability to engage in intense physical activity
  • Change in Physical Function (Six Minute Walk Test Distance)Baseline, Day 30

    The change in physical function as measured by the difference in six minute walk test distance in meters from baseline to Day 30; a greater number of meters walked indicates a higher level of physical fitness.