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Clinical Trial Summary

The main purpose of this research study is to determine if a positive psychology-based program in people who have received a stem cell transplant for blood cancer treatment is feasible and acceptable, and can help improve positive feelings, mood, quality of life, overall wellbeing and health. The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI).


Clinical Trial Description

Low levels of positive psychological well-being (PPWB) (e.g., optimism, positive affect) in allogeneic hematopoietic stem cell transplant (HSCT) recipients are common and have been associated with decreased quality of life, poorer immune response, and increased mortality. These poor health outcomes are likely mediated through deficits in health behaviors (e.g., medication adherence, physical activity), and indeed low PPWB has been prospectively associated with poorer adherence to diet, medication, and physical activity in other medical populations, independent of sociodemographic, medical comorbidity, and the ill effects of depression and anxiety. Positive psychological intervention s (PPIs) could be used to promote PPWB in the allogeneic transplant population. Despite the successful and effective use of PPIs in medical populations to reduce distress, increase quality of life, and promote health behaviors, PPI have never been tested in allogeneic recipients. -This a single center randomized trial of the PATH intervention versus usual care in patients with hematologic malignancies undergoing HSCT. The research study procedures include screening for eligibility: - Participants will be randomized equally to the two arms using randomized permuted blocks of sizes two and four, with randomization stratified by presence/absence of GVHD. As allogeneic transplant recipients with GVHD have significantly different courses of recovery, QOL, and function post transplant. - Participant will be randomized into either: The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI) or usual care. It is expected that about 70 people will take part in this research study. The National Institute of Health (NIH), National Cancer Institute (NCI) is supporting this research study by providing funding for the research ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05147311
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 17, 2021
Completion date March 31, 2025

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