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

April 2, 2026 updated by: Anthony Sung, MD

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

This study is a phase 2, multicenter, randomized controlled trial to test the application of Acceptance and Commitment Therapy (ACT) in HCT patients.

ACT is an evidence-based cognitive behavioral therapy intervention that emphasizes psychological flexibility and behaviors, helping transplant patients focus on actions that may help maintain adequate physical activity despite physical and emotional discomfort.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Anthony Sung, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
        • Contact:
        • Principal Investigator:
          • Rhonda M Merwin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Patient Inclusion Criteria:

  • Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote / electronic consent via REDCap consenting allowed per IRB policy and approval.
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • Plan to undergo allogeneic HCT in approximately 30 days
  • Males and/or females age 18 - 80 years
  • Agreement to adhere to Lifestyle Considerations throughout study duration
  • Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). NOTE: A smartphone will be provided to participants if needed.
  • Able to read/write English or Spanish (as we lack trained ACT interventionists in other languages)

Caregiver Inclusion Criteria:

  • Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote / electronic consent via REDCap consenting allowed per IRB policy and approval.
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • Males and/or females age 18-80 years
  • Agreement to adhere to Lifestyle Considerations throughout study duration
  • Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). NOTE: A smartphone will be provided to participants if needed.
  • Able to read/write English or Spanish (as we lack trained ACT interventionists in other languages)

Patient Exclusion Criteria:

  • Caregiver unwilling to enroll (as standard of care, all HCT patients are required to have a caregiver, but caregivers may decline to participate in this study which would make the patient ineligible for this study)
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Concurrent participation in another behavioral intervention research study.
  • Activity restrictions that limit one's ability to engage in intense physical activity

Caregiver Exclusion Criteria:

  • Patient unwilling to enroll

  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements

    • Concurrent participation in another behavioral intervention research study.

  • Activity restrictions that limit one's ability to engage in intense physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Education Control Arm
Participants in the education control arm will not attend ACTivate sessions.
Experimental: ACTivate Arm
Participants in the ACTivate arm will attend ACTivate sessions.
Behavioral: ACTivate sessions
ACTivate sessions are based on ACT and train psychological flexibility skills to help patients and caregivers adhere to recommendations for physical activity and nutrition in the face of an uncertain and difficult treatment course, side effects and complications. Sessions will be conducted conjointly (include both the patient and caregiver). . Interventionists will be master's level psychology professionals. All sessions will be conducted remotely and audiotaped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Function (Six Minute Walk Test Distance)
Time Frame: Baseline, Day 30
The change in physical function as measured by the difference in six minute walk test distance in meters from baseline to Day 30; a greater number of meters walked indicates a higher level of physical fitness.
Baseline, Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: Measured at Day 180
The length of hospital stay measured in days from time of transplant to time of discharge.
Measured at Day 180
Effect on Clinical Outcomes (Treatment-related Mortality)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on clinical outcomes as measured by treatment-related mortality.
Day -30, Day 30, Day 100, Year 1
Effect on Clinical Outcomes (Overall Survival)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on clinical outcomes as measured by overall survival.
Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (Short Physical Performance Battery)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on health-related quality of life as measured by performance on the Short Physical Performance Battery, which results in a score from 0 to 12 points, with a higher number indicating better physical function.
Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (30 Second Sit-to-Stand Test)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on the health-related quality of life as measured by the 30-second Sit-to-Stand Test, which measures the number of times an individual can stand up from a chair and sit back down within 30 seconds, with higher number indicating greater fitness.
Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (Lorig Self-Efficacy)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on health-related quality of life as measured by Lorig Self-Efficacy for Managing Chronic Disease Scale, which results in a numerical score between 1 and 10, with a higher number indicating higher self-efficacy.
Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (PROMIS-29+2 Profile)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on health-related quality of life as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile, which results in a numerical score between 0 and 100, with a higher number indicating better physical function.
Day -30, Day 30, Day 100, Year 1
Effect on Health-related Quality of Life (FACT-BMT)
Time Frame: Day -30, Day 30, Day 100, Year 1
Effect on health-related quality of life as measured by the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) questionnaire, which results in a numerical score between 0 and 148, with a higher number indicating a better quality of life.
Day -30, Day 30, Day 100, Year 1
Effect on Psychological Flexibility (CompACT-10 Questionnaire)
Time Frame: Baseline, Year 1
Effect on psychological flexibility as measured by the CompACT-10 Questionnaire, which assess three key factors - openness to experience, behavioral awareness, and valued action - with higher total scores indicating higher psychological flexibility.
Baseline, Year 1
Caregiver Self-Efficacy (Caregiver Inventory)
Time Frame: Baseline, Year 1
Caregiver self-efficacy as measured by the Caregiver Inventory (CGI), which results in a numerical score between 9 and 189, with a higher number indicating greater caregiver self-efficacy.
Baseline, Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthony Sung, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIT-2025-ACTivate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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