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

Not Applicable

Active, not recruiting

• Conditions: Hematopoietic Steam Cell Transplantation (HCT)
• Interventions: Behavioral: Acceptance and Commitment Therapy (ACT)

• Registration Number: NCT04423939
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-10-14
• Primary Completion: 2022-05-19
• Results First Submitted: 2023-05-19
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-11-29
• Last Update Posted: 2024-11-29
• Study Completion: 2025-02-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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

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Exclusion Criteria

• Under the age of 18
• Non-English speaking
• Has a caregiver unwilling to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caregivers	Acceptance and Commitment Therapy (ACT)	20 HCT patients caregivers at Duke
Hematopoietic Stem Cell Transplantation (HCT) Patients	Acceptance and Commitment Therapy (ACT)	20 HCT patients at Duke

Primary Outcome Measures

Name	Time	Method
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)	Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT	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.
Hospital Length of Stay, as Measured by Medical Record Review	Up to Day 90	Hospital length of stay in days

Trial Locations

Locations (1)

Lauren Hill; 🇺🇸 Raleigh, North Carolina, United States