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Behavioral Intervention

Positive Psychology for Bone Marrow Transplant Survivors (PATH-4 Trial)

N/A

Recruiting

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 up to 40 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out