Clinical trial NCT06328127: Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
Official title: Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: stem cell transplant
positive psychology intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Duke University
name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2024-03-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care.

Detailed description: Patients undergoing hematopoietic stem cell transplantation (HSCT) deal with numerous physical and psychological symptoms during acute hospitalization and recovery. Of the few psychosocial interventions tailored to the needs of the HSCT population, most focus on the needs of patients in the pre-transplant phase or during the HSCT hospitalization, but not during the acute recovery period starting at 100-days post-HSCT. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH). This intervention encourages patients to perform simple and enjoyable structured activities that increase the intensity of positive thoughts and emotions. With this multi-site randomized clinical trial, the investigators aim to find out whether PATH can improve psychological distress and quality of life in HSCT survivors, compared to usual care, using validated assessment tools.

Eligibility criteria: Inclusion Criteria:

* Adult patients (aged 18 years and older) undergoing allogeneic HSCT and are approaching 100-days post-HSCT
* Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
* Access to a basic telephone

Exclusion Criteria:

* Patients who underwent allogeneic HSCT for benign hematologic conditions
* Patients who received outpatient HSCT
* Patients with severe psychiatric or cognitive conditions, such as dementia, determined by their transplant oncologist to make them unable to provide informed consent or comply with study procedures

Primary outcomes:
measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
timeFrame: 10 weeks
Secondary outcomes:
measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
timeFrame: Up to 40 weeks
measure: Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale
timeFrame: Up to 40 weeks
measure: Gratitude based on the Gratitude Questionnaire
timeFrame: Up to 40 weeks
measure: Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale
timeFrame: Up to 40 weeks
measure: Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20
timeFrame: Up to 40 weeks
measure: Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Brigham and Women's Hospital
name: Hermioni Amonoo, MD, MPP, MPH
role: PRINCIPAL_INVESTIGATOR
References: