ACT to Reduce Morbidity and Mortality in Hematopoietic St... | NCT07516314

NCT07516314

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Education Control Arm	No Intervention	Participants in the education control arm will not attend ACTivate sessions.
ACTivate Arm	Experimental	Participants in the ACTivate arm will attend ACTivate sessions.	Behavioral: ACTivate sessions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACTivate sessions	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Physical Function (Six Minute Walk Test Distance)	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 Outcomes

Measure	Description	Time Frame
Length of Stay	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)	Effect on clinical outcomes as measured by treatment-related mortality.

Eligibility Module

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

Name	Role	Phone	Extension	Email
Anthony Sung, MD	Contact	9135886030		asung2@kumc.edu

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Cancer Center		Kansas City	Kansas	66160	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Oncology Center of Excellence (OCE). Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices Guidance for Industry - Draft Guidance. December 2024. Available from: https://www.fda.gov/media/184745/download . Accessed 01-21-2025.
	Background	U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry - E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1). January 2013. Available from: https://www.fda.gov/media/84857/download Accessed 01-21-2025.
	Background	Protocol Review & Monitoring Committee (PRMC) - About the PRMC. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/prmc/Pages/default.aspx Accessed 09-20-2024.
	Background	The University of Kansas Cancer Center Clinical Trials Office Policy - Executive Resourcing Committee Submission Requirements. Version dated 08-03-2022. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/cto/Documents/CTO%20Policy_ERC%20Submission.pdf#search=executive%20resource Accessed 09-20-2024.
	Background	The University of Kansas Cancer Center General Administration Guidance Document - Use of Investigator Initiated Steering Committee. Version dated 07-31-2023. Cited 09-20-2024. Available from: https://kumed.sharepoint.com/sites/mykumc/cto-training/Documents/Guidance_Use%20of%20Investigator%20Initiated%20Steering%20Committee.pdf#search=steering%20committee%20guidance%20document Accessed 09-20-2024.