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NCT04423939 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
33
Enrollment target

NCT04423939: Completed NA study, sponsored by Duke University.

NCT04423939 is a NA study that has completed, run by Duke University. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04423939, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
33 participants
Enrollment target

Study Summary

This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.

Primary Outcome

The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Interventions

  • BEHAVIORAL Acceptance and Commitment Therapy (ACT)

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2020-10-14
Est. Completion 2025-02-01
Phase NA
Duke University

1,725 total trials

What the finished NCT04423939 record still lists

NCT04423939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Acceptance and Commitment Therapy (ACT) is the first listed.

NCT04423939 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04423939 about?

NCT04423939 is a clinical study titled "ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients". This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this stud...

What is the current status of trial NCT04423939?

This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2020-10-14. Estimated completion is 2025-02-01.

What interventions are being tested in trial NCT04423939?

The interventions under investigation include: Acceptance and Commitment Therapy (ACT) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04423939?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04423939's enrollment target sits among peer trials

33 1574th of 2000 higher than 423 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04423939, the US trial registry maintained by the National Library of Medicine. NCT04423939 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.