NCT05147311

Positive Psychology Intervention In HSCT

Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 interventions (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 graft-versus-host disease (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

Conditions

• Hematologic Malignancy
• Hematopoietic/Lymphoid Cancer
• Blood Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Positive Psychology Intervention	Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.

Timeline

• Start date: 2021-11-17
• Primary completion: 2023-05-16
• Completion: 2023-08-28
• First posted: 2021-12-07
• Last updated: 2024-07-30
• Results posted: 2024-07-30

Locations

1 site across 1 country: United States