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

NCT ID: NCT04423939

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2025-02-01

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hematopoietic Stem Cell Transplantation (HCT) Patients

20 HCT patients at Duke

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type: 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

20 HCT patients caregivers at Duke

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type: 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.

Interventions

Acceptance and Commitment Therapy (ACT)

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Sung, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Lauren Hill

Raleigh, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00105683

Identifier Type: -

Identifier Source: org_study_id