Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06153797

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hematologic Malignancy Caregiver Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PATH-C

Behavioral

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.

Primary outcomes

  1. PATH-C Intervention Feasibility

    Time frame: Up to 10 weeks

    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.

Secondary outcomes

  1. PATH-C Intervention Acceptability

    Time frame: Up to 10 weeks

    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.

  2. Physical activity longitudinally based on ActiGraph GT3X+ accelerometer

    Time frame: Up to 20 weeks (+/- 28 days)

    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.

  3. Caregiver Quality of Life based on the CarGOQOL

    Time frame: Up to 20 weeks (+/- 28 days)

    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.

  4. Anxiety Symptoms based on the HADS-Anxiety Subscale

    Time frame: Up to 20 weeks (+/- 28 days)

    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.

  5. Depression Symptoms based on the HADS-Depression Subscale

    Time frame: Up to 20 weeks (+/- 28 days)

    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.

  6. Caregiving Burden based not the Caregiver Reaction Assessment (CRA)

    Time frame: Up to 20 weeks (+/- 28 days)

    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.

Other outcomes

  1. Optimism

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare optimism using the 10-item Life Orientation Test-Revised (LOT-R) between the two groups.

    The LOT-R ranges from 0 to 24, with higher scores indicating greater optimism.

  2. Positive Affect

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare positive affect using the 15-item Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Short Form between the two groups.

    The PROMIS Positive Affect Short Form ranges from 15 to 75, with higher scores indicating greater positive affect.

  3. Life Satisfaction

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare life satisfaction using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction Questionnaire between the two groups.

    The PROMIS General Life Satisfaction Questionnaire ranges from 10 to 60, with higher scores indicating greater satisfaction with life.

  4. Gratitude

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare gratitude using the 6-item Gratitude Questionnaire between the two groups.

    The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.

  5. Flourishing

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare flourishing using the 8-item Flourishing Scale between the two groups.

    The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths.

  6. Self-Efficacy

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups.

    The CASE-t ranges from 0 to 170, with higher scores indicating greater self-efficacy.

  7. Perceived Coping Skills

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare coping skills using the Measure of Current Status (MOCS-A) between the two groups.

    The MOCS-A ranges from 0 to 52, with higher scores indicating having more coping skills.

  8. Stress Resilience

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare stress resilience using the 6-item Brief Resilience Scale (BRS) between the two groups.

    The BRS ranges from 6 to 30, with higher scores indicating greater stress resilience.

  9. Locus of Control

    Time frame: Up to 20 weeks (+/- 28 days)

    Compare locus of control using the Multidimensional Health Locus of Control (MHLC) scale, Form A between the two groups.

    The MHLC Form A ranges from 6 to 36 for each locus of control category (internal, powerful others, or chance), and higher scores suggest greater belief in each category as the source of health locus of control.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • American Society of Hematology
  • Dana-Farber Cancer Institute
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Acronym: PATH-C

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Dec 1, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.