Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors (PATH-4)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Behavioral: PATH

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hermioni Amonoo, MD, MPP; Phone Number: 617-732-5056; Email: Hermioni_Amonoo@dfci.harvard.edu
• Study Contact Backup: Name: Annabella Boardman, BA; Email: aboardman1@bwh.harvard.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
      • Contact: Heather Jim, PhD; Email: heather.jim@moffitt.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute
      • Contact: Thomas LeBlanc, MD; Email: thomas.leblanc@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Affect in the Transplantation of Hematopoietic Stem Cells (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.	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.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale	Compare anxiety symptoms between the two groups at 13 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.	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 weeks to 40 weeks
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 indicate greater physical activity.	Up to 40 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Dana-Farber Cancer Institute; Duke University; H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Hermioni Amonoo, MD, MPP, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: stem cell transplant; positive psychology intervention
• Other Study ID Numbers: 23-691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No