Recruiting

Positive Psychology

Sponsor:

Brigham and Women's Hospital

Code:

NCT06328127

Conditions

Hematopoietic Stem Cell Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PATH

Study Details

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

Study ID

NCT06328127

Start date

Dec 17, 2024

Status verified date

Nov, 2025

Completion date

May 31, 2030

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Hermioni Amonoo, MD, MPP, MPH

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

Isabella Larizza, BSc

ilarizza@bwh.harvard.edu

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Heather Jim, PhD

heather.jim@moffitt.org

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Hermioni Amonoo, MD, MPP, MPH

617-525-7472Hermioni_Amonoo@dfci.harvard.edu

Principal Investigator:

Hermioni Amonoo, MD, MPP, MPH

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Thomas LeBlanc, MD

thomas.leblanc@duke.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • stem cell transplant
  • positive psychology intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-11-13.