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

NCT04423939 | Completed Results

• 1 other identifier: Pro00105683
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Steam Cell Transplantation (HCT)

Outcome Measures

Primary Outcomes (2)

• Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)

  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.

  Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT

• Hospital Length of Stay, as Measured by Medical Record Review

  Hospital length of stay in days

  Up to Day 90

Other Outcomes (47)

• Change in Shannon Diversity, as Measured by Stool Samples

  Baseline, Day 90

• Change in Shannon Diversity, as Measured by Stool Samples

  Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3

• Hospital Length of Stay, as Measured by Medical Record Review

  Up to 3 years

Study Arms (2)

Hematopoietic Stem Cell Transplantation (HCT) Patients

EXPERIMENTAL

20 HCT patients at Duke

Behavioral: Acceptance and Commitment Therapy (ACT)

Caregivers

EXPERIMENTAL

20 HCT patients caregivers at Duke

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.

Caregivers; Hematopoietic Stem Cell Transplantation (HCT) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Lauren Hill

Raleigh, North Carolina, 27608, United States

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Anthony Sung
• Organization: Duke University Medical Center

anthony.sung@duke.edu

919-668-1000

Study Officials

• Anthony Sung, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: October 14, 2020
• Primary Completion: May 19, 2022
• Study Completion: February 1, 2025
• Last Updated: November 25, 2025
• Results First Posted: November 29, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)