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

Mass General Brigham

Status: Not yet enrolling

Conditions: Hematopoietic Stem Cell Transplant

Treatments: Behavioral: PATH

Study type: Interventional

Funder types: Other

Identifiers

NCT06328127

23-691

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: PATH

Usual Care

No Intervention group

Description:

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.