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NCT07516314

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

Sponsor: Anthony Sung, MD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

476

Start Date

2026-05

Completion Date

2031-04

Last Updated

2026-04-07

Healthy Volunteers

Yes

Conditions

Stem Cell Transplant Patients

Interventions

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.

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

Locations (2)

University of Kansas Cancer Center

Kansas City, Kansas, United States

Duke University

Durham, North Carolina, United States