Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

NCT06328127 | Recruiting

• 1 other identifier: 23-691
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Hematopoietic Stem Cell Transplant

Keywords

stem cell transplant; positive psychology intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale

  Up to 40 weeks

• Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale

  Up to 40 weeks

• Gratitude based on the Gratitude Questionnaire

  Up to 40 weeks

• Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale

  Up to 40 weeks

• Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20

  Up to 40 weeks

Study Arms (2)

Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)

EXPERIMENTAL

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

Usual Care

NO 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.

Interventions

PATH BEHAVIORAL

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.

Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who underwent allogeneic HSCT for benign hematologic conditions
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Duke University: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

• Hermioni Amonoo, MD, MPP, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermioni Amonoo, MD, MPP, MPH

CONTACT

617-525-7472; hermioni_amonoo@dfci.harvard.edu

Isabella Larizza, BSc

CONTACT

ilarizza@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Well-Being and Cancer Research Program

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 25, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2030
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Contact the study investigator at hermioni\ amonoo@dfci.harvard.edu

Locations

US (3)