Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
- Conditions
- Hematopoietic Stem Cell Transplant
- Interventions
- Behavioral: PATH
- Registration Number
- NCT06328127
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH) PATH 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.
- Primary Outcome Measures
Name Time Method Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale 10 weeks Compare anxiety symptoms between the two groups at 10 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A).
The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.
- Secondary Outcome Measures
Name Time Method Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale Up to 40 weeks Compare positive affect longitudinally between the two groups using the 10-item Positive and Negative Affect Schedule (PANAS) Positive Affect Subscale.
The PANAS Positive Affect Subscale ranges from 10-50, with higher scores indicating higher levels of positive affect.Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Up to 40 weeks Compare quality of life longitudinally between the two groups using the 47-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).
The FACT-BMT consists of 5 subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. The FACT-BMT ranges from 0-148, with higher scores indicating better quality of life.Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale Up to 40 weeks Compare depression symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale.
The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms.Gratitude based on the Gratitude Questionnaire Up to 40 weeks Compare gratitude longitudinally between the two groups using the 6-item Gratitude Questionnaire.
The Gratitude Questionnaire ranges from 6-42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale Up to 40 weeks Compare anxiety symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale.
The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20 Up to 40 weeks Compare physical function longitudinally between the two groups using the 20-item Patient-Reported Outcomes Measurement Information System-Physical Function-20 (PROMIS-PF-20).
The PROMIS-PF-20 ranges from 20 to 100, with higher scores indicating better physical functioning.
Trial Locations
- Locations (3)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States