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Behavioral Intervention

Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH) for Bone Marrow Transplant (PATH-4 Trial)

N/A
Waitlist Available
Led By Hermioni Amonoo, MD, MPP, MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks to 40 weeks
Awards & highlights

PATH-4 Trial Summary

"This trial is studying how a positive psychology program called PATH can help improve anxiety, depression, and quality of life in people who have had a stem cell transplant, compared to standard care."

Who is the study for?
This trial is for adults over 18 who have had a bone marrow transplant (allogeneic HSCT) and are about 100 days post-transplant. They must be able to communicate in English or Spanish and have access to a phone. It's not for those with benign hematologic conditions, outpatient HSCT, or severe psychiatric issues like dementia.Check my eligibility
What is being tested?
The study is testing the PATH program, which uses positive psychology techniques to see if it can improve anxiety, depression symptoms, and life quality after bone marrow transplant compared to usual care. Participants will be randomly assigned to either receive PATH or continue with their standard follow-up.See study design
What are the potential side effects?
Since PATH involves psychological support rather than medication, there may not be physical side effects. However, participants might experience emotional discomfort when discussing personal experiences during sessions.

PATH-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks to 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale
Gratitude based on the Gratitude Questionnaire
+3 more
Other outcome measures
Coping based on the Brief-COPE questionnaire
Flourishing based on the Flourishing Scale
Optimism based on the Life Orientation Test-Revised (LOT-R)
+3 more

PATH-4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)Experimental Treatment1 Intervention
Participants recruited from the Dana-Farber Cancer Institute, Duke Cancer Institute, and Moffitt Cancer Center who are randomized to the intervention/experimental arm will receive the PATH intervention, which is focused on gratitude, strengths, and meaning, as well as focused exercises on goal-setting and tracking daily physical activity. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
Group II: Usual CareActive Control1 Intervention
Participants recruited from the Dana-Farber Cancer Institute, Duke Cancer Institute, and Moffitt Cancer Center who are randomized to the usual care arm will receive their usual support from the HSCT team, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PATH
2006
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,430 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,580 Total Patients Enrolled
Duke UniversityOTHER
2,363 Previous Clinical Trials
3,420,086 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"Information from clinicaltrials.gov shows that the current trial is not actively seeking participants. Although it was initially posted on June 1st, 2024 and last revised on March 18th, 2024. Despite this trial being inactive in recruitment status at present, there are currently 46 other trials actively enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
Hermioni L.Amonoo, MD, MPP, MPH 2024. "Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06328127.
All > Stem Cell Transplant
~267 spots leftby Jun 2026
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