Clinical trial NCT06153797: A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors
Official title: Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Caregiver
Keywords: Hematologic Malignancy
Hematopoietic Stem Cell Transplant
Caregivers of Patients with Cancer
Positive Psychology Intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Robert Wood Johnson Foundation
name: American Society of Hematology
First posted: 2023-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).

Detailed description: Family and friend caregivers are vital care providers throughout the entire care continuum for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). These caregivers must manage multiple time-consuming responsibilities, including monitoring vital signs and side effects of treatment, administering medications, and coordinating transportation to and from medical appointments. The substantial caregiving burden among caregivers of patients undergoing HSCT is associated with increased symptoms of depression, anxiety, and fatigue. Symptoms such as fatigue and depression in HSCT caregivers may undermine attempts to maintain regular physical activity routines, which may impact essential health outcomes such as cardiovascular health.

With persistent shortages in the mental health workforce needed to address these psychological needs of HSCT caregivers adequately, remotely-delivered psychosocial interventions offer an innovative approach to overcome the unmet psychological needs of this population. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells for Caregivers (PATH-C), tailored to the unique psychological needs of HSCT caregivers. With this study, the investigators will establish the impact of PATH-C on participant-reported outcomes compared to usual care.

The study will use validated questionnaires to measure caregivers' quality of life, caregiver burden, psychological distress symptoms, positive psychological well-being (e.g., positive affect, gratitude), and self-management targets (e.g., coping, self-efficacy). The study will also use the validated ActiGraph GT3X+ accelerometer to measure minutes/day of moderate-to-vigorous physical activity, light activity, and sedentary leisure time.

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.

Primary outcomes:
measure: PATH-C Intervention Feasibility
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: PATH-C Intervention Acceptability
timeFrame: Up to 10 weeks
measure: Physical activity longitudinally based on ActiGraph GT3X+ accelerometer
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Caregiver Quality of Life based on the CarGOQOL
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Anxiety Symptoms based on the HADS-Anxiety Subscale
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Depression Symptoms based on the HADS-Depression Subscale
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Caregiving Burden based not the Caregiver Reaction Assessment (CRA)
timeFrame: Up to 20 weeks (+/- 28 days)
Other outcomes:
measure: Optimism
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Positive Affect
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Life Satisfaction
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Gratitude
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Flourishing
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Self-Efficacy
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Perceived Coping Skills
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Stress Resilience
timeFrame: Up to 20 weeks (+/- 28 days)
measure: Locus of Control
timeFrame: Up to 20 weeks (+/- 28 days)
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hermioni Amonoo, MD, MPP, MPH
role: PRINCIPAL_INVESTIGATOR
References: