N/A
Completed N=28
ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients
Hematopoietic Steam Cell Transplantation (HCT)
Source: ClinicalTrials.gov NCT04423939 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT) — 449; 468; 478 meters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT) |
449; 468; 478 | — |
| PRIMARY Hospital Length of Stay, as Measured by Medical Record Review |
— | — |
Eligibility Criteria
Inclusion Criteria
Patient:
- Over the age of 18
- Undergoing allogeneic HCT for any cancer or noncancer illness
- English speaking
- Has a caregiver willing to participate
Caregiver:
- Over the age of 18
- English speaking
Exclusion Criteria
- Under the age of 18
- Non-English speaking
- Has a caregiver unwilling to participate
Data sourced from ClinicalTrials.gov (NCT04423939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.