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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Physical Function (Six Minute Walk Test Distance) [Срок оценки: Baseline, Day 30]

Вторичные конечные точки (10)

• Length of Stay [Срок оценки: Measured at Day 180]
• Effect on Clinical Outcomes (Treatment-related Mortality) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Clinical Outcomes (Overall Survival) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Health-related Quality of Life (Short Physical Performance Battery) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Health-related Quality of Life (30 Second Sit-to-Stand Test) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Health-related Quality of Life (Lorig Self-Efficacy) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Health-related Quality of Life (PROMIS-29+2 Profile) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Health-related Quality of Life (FACT-BMT) [Срок оценки: Day -30, Day 30, Day 100, Year 1]
• Effect on Psychological Flexibility (CompACT-10 Questionnaire) [Срок оценки: Baseline, Year 1]
• Caregiver Self-Efficacy (Caregiver Inventory) [Срок оценки: Baseline, Year 1]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• University of Kansas Cancer Center — Kansas City
• Duke University — Durham

Публикации

• 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. Dece
• 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.
• 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.
• 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.
• 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.
• Fitzmaurice, G., Laird, N.M., and Ware, J.H., Applied Longitudinal Analysis. Wiley Series in Probability and Statistics2004, New York: John Wiley & Sons.
• Atkins DC. Using multilevel models to analyze couple and family treatment data: basic and advanced issues. J Fam Psychol. 2005 Mar;19(1):98-110. doi: 10.1037/0893-3200.19.1.98. PMID 15796656
• Adachi H. Cardiopulmonary Exercise Test. Int Heart J. 2017 Oct 21;58(5):654-665. doi: 10.1536/ihj.17-264. Epub 2017 Sep 30. PMID 28966333

Идентификаторы

NCT: NCT07516314 · IIT-2025-ACTivate

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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