Actively Recruiting
Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
Led by Brigham and Women's Hospital · Updated on 2025-11-13
400
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
D
Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a positive psychology program called PATH on anxiety, depression, and quality of life among adults who have survived hematopoietic stem cell transplantation (HSCT). The study focuses on the recovery phase starting around 100 days after HSCT, a time when patients may experience both physical and psychological challenges. This multi-site randomized trial aims to compare the PATH intervention with usual care to see if it helps improve mental health and well-being using validated tools. The PATH intervention is delivered remotely by phone and includes three modules lasting three weeks each. These modules focus on gratitude, personal strengths, meaning, goal-setting, and daily physical activity, with weekly 30-minute guided sessions led by a trained interventionist. Participants are randomized to either receive PATH or continue with their usual care and support from their HSCT teams. Both groups complete questionnaires at scheduled times throughout the study. Participants will be involved in completing questionnaires in person, online, by phone, or mail at several points up to 40 weeks. The main outcome measured is anxiety at 10 weeks using a standardized scale, with other outcomes including depression symptoms, gratitude, positive affect, physical function, and quality of life monitored over time. The study includes safety and adherence monitoring to assess the impact of the intervention during recovery. Participation lasts for several months with assessments planned to capture changes over this period.
CONDITIONS
Brief Title
Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years and older undergoing allogeneic HSCT and approaching 100 days post-HSCT
- Ability to speak, read, and respond to questions in English or Spanish
- Access to a basic telephone
You will not qualify if you...
- Underwent allogeneic HSCT for benign hematologic conditions
- Severe psychiatric or cognitive conditions such as dementia that impair informed consent or study compliance as determined by the transplant oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 9 weeks
Participants receive a remotely-delivered positive psychology intervention consisting of three 3-week modules focused on gratitude, personal strengths, meaning, and physical activity guided by a trained interventionist in weekly 30-minute sessions.
Weekly phone sessions for 9 weeks
Duration - Up to 40 weeks
Participants complete questionnaires to assess psychological distress and quality of life outcomes up to 40 weeks after starting the intervention.
Periodic questionnaire assessments (in-person, remote, or by mail)
Trial Site Locations
Total: 3 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
H
Hermioni Amonoo, MD, MPP, MPH
I
Isabella Larizza, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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