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ClinicalTrials.gov ID

NCT07516314

Lead Sponsor

Anthony Sung, MDOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

476Estimated

Last Update Posted

Apr 7, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

Jan 2030Estimated

Completion Date

Apr 2031Estimated

Official Title

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

Brief Summary

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.

• Stem Cell Transplant Patients

• ACTivate sessions

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Anthony Sung, MDOTHER

dorothy.mayo@duke.edu919-668-1935