Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

Hematopoietic Stem Cell Transplant Clinical Trial

— PATH-4  

Official title:

Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328127
• Other study ID #: 23-691
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 30, 2030

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: Hermioni Amonoo, MD, MPP, MPH
• Phone: 617-525-7472
• Email: hermioni_amonoo[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 30, 2030
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant

Intervention

Behavioral:
• PATH
PATH, a phone-delivered positive psychology intervention for patients who have undergone HSCT, consists of three 3-week modules. The first module focuses on gratitude and physical activity goal setting. The second module focuses on personal strengths and resources to enhance daily physical activity. The third module focuses on meaning and assessing barriers to physical activity. The third week of each module is an integration exercise dedicated to help participants explore practical ways of incorporating the themes for the given module into daily life. A trained interventionist will guide participants to complete each 30-minute weekly session.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Duke Cancer Institute	Durham	North Carolina
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Dana-Farber Cancer Institute, Duke University, H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Flourishing based on the Flourishing Scale	Compare flourishing longitudinally between the two groups using the 8-item Flourishing Scale.; The Flourishing Scale ranges from 8-56, with higher scores indicating more flourishing via psychological resources and strengths.	Up to 40 weeks
Other	Optimism based on the Life Orientation Test-Revised (LOT-R)	Compare dispositional (trait) optimism longitudinally between the two groups using the 10-item Life Orientation Test-Revised (LOT-R).; The LOT-R ranges from 0-24, with higher scores indicating higher levels of dispositional optimism.	Up to 40 weeks
Other	Coping based on the Brief-COPE questionnaire	Compare coping skills longitudinally using the 28-item Brief-COPE between the two groups.; The Brief-COPE assesses the use of 14 coping strategies with two items for each strategy. Scores for each strategy range from 2 to 8, with higher scores indicating greater use of that particular coping strategy.	Up to 40 weeks
Other	Post-traumatic stress based on the Post-traumatic Stress Checklist-Civilian Version	Compare post-traumatic stress disorder symptoms longitudinally between the two groups using the 17-item Post-traumatic Stress Checklist-Civilian Version (PCL-C).; The PCL-C ranges from 17-85, with higher scores indicating greater severity of post-traumatic stress disorder symptoms.	Up to 40 weeks
Other	Steps per day based on the ActiGraph accelerometer	Compare steps per day longitudinally between the two groups using the ActiGraph GT3X+ accelerometer.; Greater steps per day indicate greater physical activity.	Up to 40 weeks
Other	Sedentary leisure time based on the ActiGraph accelerometer	Compare sedentary leisure time longitudinally between the two groups using the ActiGraph GT3X+ accelerometer.; Less sedentary leisure time indicates greater physical activity.	Up to 40 weeks
Primary	Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale	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.	10 weeks
Secondary	Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale	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.	Up to 40 weeks
Secondary	Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale	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.	Up to 40 weeks
Secondary	Gratitude based on the Gratitude Questionnaire	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.	Up to 40 weeks
Secondary	Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale	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.	Up to 40 weeks
Secondary	Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20	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.	Up to 40 weeks
Secondary	Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)	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.	Up to 40 weeks