Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

NCT ID: NCT06328127

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2030-05-31

Brief Summary

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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

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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.

Conditions

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Hematopoietic Stem Cell Transplant

Keywords

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stem cell transplant positive psychology intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PATH

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hermioni L.Amonoo, MD, MPP, MPH

Director, Well-Being and Cancer Research Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hermioni Amonoo, MD, MPP, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Duke Cancer Institute

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hermioni Amonoo, MD, MPP, MPH

Role: CONTACT

Phone: 617-525-7472

Email: [email protected]

Isabella Larizza, BSc

Role: CONTACT

Email: [email protected]

Facility Contacts

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Heather Jim, PhD

Role: primary

Hermioni Amonoo, MD, MPP, MPH

Role: primary

Thomas LeBlanc, MD

Role: primary

Other Identifiers

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23-691

Identifier Type: -

Identifier Source: org_study_id