Positive psychology intervention for caregivers of patients with hematologic malignancies

Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors

This study is testing a new online program to see if it can help caregivers of patients with blood cancers feel better and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06153797 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a remotely-delivered positive psychology intervention called PATH-C, aimed at improving the psychological well-being, quality of life, and physical activity of caregivers for patients undergoing hematopoietic stem cell transplantation (HSCT). Caregivers often face significant emotional and physical burdens, which can lead to increased symptoms of depression and anxiety. The study will compare the outcomes of caregivers receiving the PATH-C intervention to those receiving usual care, using validated questionnaires to assess improvements. This innovative approach addresses the unmet psychological needs of HSCT caregivers, particularly in light of the shortage of mental health resources.

Who should consider this trial

Good fit: Ideal candidates are adult caregivers aged 18 and older who provide care for patients undergoing HSCT at Dana-Farber Cancer Institute.

Not a fit: Patients who are caregivers for individuals undergoing HSCT for benign hematologic conditions or those with acute psychiatric issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance the mental health and overall quality of life for caregivers of HSCT patients.

How similar studies have performed: Other studies have shown promise in using positive psychology interventions for caregiver support, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Adult caregivers (aged 18 years and older) of patients undergoing allogeneic or autologous HSCT at Dana-Farber Cancer Institute for a hematologic malignancy.
* A relative or a friend who either lives with the patient or has in-person contact with them at least twice per week and is identified as the primary caregiver for HSCT.
* Ability to speak English and able to complete questionnaires with minimal assistance of an interpreter as this is a feasibility trial of the PATH-C intervention which is currently only available in English.

Exclusion Criteria:

* Caregivers of patients undergoing HSCT for benign hematologic conditions.
* Caregivers with acute or unstable psychiatric conditions which the treating transplant clinician believes prohibits informed consent or compliance with study procedures.
* Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS) screening tool that is sensitive and specific for screening for cognitive impairment in research participants.

Where this trial is running

Boston, Massachusetts

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Hermioni Amonoo, MD, MPP, MPH — Brigham and Women's Hospital
• Study coordinator: Hermioni Amonoo, MD, MPP, MPH

Conditions: Hematologic Malignancy, Caregiver, Hematopoietic Stem Cell Transplant, Caregivers of Patients with Cancer, Positive Psychology Intervention