A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors

Study Overview
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Brief Summary
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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
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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, we 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, we 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.

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

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Behavioral: PATH-C


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATH-C<br>Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Caregivers of patients undergoing HSCT will receive the PATH-C intervention to learn to reflect on their positive emotions and consistently use and incorporate positive psychology exercises in their daily routine, as well as learn how to set goals and track their physical activity (i.e., with an activity tracker) daily while caring for a loved one undergoing HSCT. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. | Behavioral: PATH-C<br>* PATH-C, a phone-delivered positive psychology intervention for caregivers of patients undergoing HSCT, consists of the following nine sessions: 1) Enhancing gratitude and increasing awareness for physical activity; 2) Expressing gratitude and goal setting for physical activity; 3) Integrating gratitude and goals for physical activity; 4) Personal strengths and environmental scan to enhance physical activity; 5) Enhancing strengths via reflection on past successes; 6) Integrating strengths to enhance well-being and physical activity; 7) Engaging in enjoyable and meaningful activities; 8) Promoting optimism and integrating long-term activity habits; 9) Integrating meaning for sustainable physical activity goals. Each session takes about 30 minutes, and a trained interventionist will guide participants to complete the sessions.<br>|
| No Intervention: Usual Care<br>Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. Participants in the usual care arm will receive their usual support from the HSCT team as caregivers of patients undergoing HSCT, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team. Patients in the usual care and PATH-C groups will be permitted to use all supportive care services per standard care. We will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PATH-C Intervention Feasibility | PATH-C Intervention Feasibility is defined as >60% of eligible participants enrolling in the study and >60% of enrolled participants who start the intervention completing at least 6/9 intervention sessions. | Up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PATH-C Intervention Acceptability | Acceptability will be measured using weekly ratings of the ease and utility of each exercise (0=very difficult/not helpful; 10=very easy/very helpful) and will use a threshold of a mean combined score of 7.0/10.0. | Up to 9 weeks | 
| Physical activity longitudinally based on ActiGraph GT3X+ accelerometer | Compare physical activity levels using the ActiGraph GT3X+ accelerometer between the two groups. Greater steps/day and lower sedentary leisure time indicate greater physical activity. | Up to 18 weeks | 
| Caregiver Quality of Life based on the CarGOQOL | Compare caregiver quality of life using the 29-item CareGiver Oncology Quality of Life questionnaire (CarGOQOL) between the two groups. Higher scores on the CarGOQOL (normalized score range, 1-100) indicate better quality of life. | Up to 18 weeks | 
| Anxiety Symptoms based on the HADS-Anxiety Subscale | Compare anxiety symptoms using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale between the two groups. The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms. | Up to 18 weeks | 
| Depression Symptoms based on the HADS-Depression Subscale | Compare depression symptoms using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale between the two groups. The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms. | Up to 18 weeks | 
| Caregiving Burden based not the Caregiver Reaction Assessment (CRA) | Compare caregiving burden using the 24-item Caregiver Reaction Assessment (CRA) between the two groups. The CRA ranges from 24 to 120, with higher scores indicating greater caregiving burden. | Up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematologic Malignancy