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

NCT06153797 | Active Not Recruiting

• 1 other identifier: 23-509
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematologic Malignancy; Caregiver

Keywords

Hematologic Malignancy; Hematopoietic Stem Cell Transplant; Caregivers of Patients with Cancer; Positive Psychology Intervention

Outcome Measures

Primary Outcomes (1)

• 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 10 weeks

Secondary Outcomes (6)

• PATH-C Intervention Acceptability

  Up to 10 weeks

• Physical activity longitudinally based on ActiGraph GT3X+ accelerometer

  Up to 20 weeks (+/- 28 days)

• Caregiver Quality of Life based on the CarGOQOL

  Up to 20 weeks (+/- 28 days)

• Anxiety Symptoms based on the HADS-Anxiety Subscale

  Up to 20 weeks (+/- 28 days)

• Depression Symptoms based on the HADS-Depression Subscale

  Up to 20 weeks (+/- 28 days)

Other Outcomes (9)

• Optimism

  Up to 20 weeks (+/- 28 days)

• Positive Affect

  Up to 20 weeks (+/- 28 days)

• Life Satisfaction

  Up to 20 weeks (+/- 28 days)

Study Arms (2)

PATH-C

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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. The investigators will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).

Interventions

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.

PATH-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Robert Wood Johnson Foundation: collaborator
• American Society of Hematology: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hermioni Amonoo, MD, MPP, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-site randomized efficacy trial of the PATH-C intervention in 80 caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. 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 assign each participant to either PATH-C versus usual care.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Well-Being and Cancer Research Program

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: January 1, 2024
• Primary Completion: November 17, 2025
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Contact the study investigator at hermioni\ amonoo@dfci.harvard.edu

Locations

US (1)