Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing HSCT (PATH-C)

Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation

Caregivers (i.e., family and friends) of patients with cancer are essential in providing care during cancer treatment. For patients who are undergoing a hematopoietic stem cell transplant/transplantation (HSCT) as treatment for their cancer, caregivers are even more crucial before, during, and after their transplantation. Although HSCT is potentially curative for some patients with blood cancers, the treatment is intensive and accompanied by a prolonged hospitalization as patients recover from the toxic side-effects of chemotherapy and medical complications from the transplantation. Unsurprisingly, during the entire transplantation process, caregiver burden is high as caregivers witness and support their loved ones through multiple treatment-related complications, management of ongoing physical symptoms, and complex medication schedules. Caregiver burden leads to poor health outcomes including poor caregiver quality of life, fatigue, depression, anxiety, impaired physical health, and low levels of resilience and positive emotions. Reducing distress and enhancing positive emotions can both reduce caregiver burden and improve caregiver quality of life. However, the few interventions in the HSCT caregiver population have mostly focused on mitigating distress, despite strong evidence that enhancing positive emotions in caregivers reduces caregiver burden and promotes physical and psychological health. To address this gap, we hope to develop and test an intervention that emphasizes positive emotions in caregivers of HSCT recipients. A scalable and accessible positive emotion-based intervention tailored to the unique needs of HSCT recipients' caregivers provides a new line of behavioral intervention resources that could offer benefit to both caregivers and patients and could be generalizable to other cancer caregivers.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy; Caregiver
• Intervention / Treatment: Behavioral: Positive Psychology Intervention

Detailed Description

The proposed project (PATH-C) entails two phases:

1. Phase one is an open-pilot trial in 5 caregivers of patients undergoing HSCT to refine the PATH intervention.
2. Phase two is single-arm open-pilot trial evaluating the feasibility and acceptability of the PATH intervention in 20 caregivers of patients undergoing HSCT.

All participants will be approached in-person at the routine HSCT patient consent clinic visit or, with patient permission, over the phone if the caregiver is not physically present at the consent visit for eligibility determination. Interested participants will be screened based on the inclusion/exclusion criteria and verbal consent will be obtained.

Upon consent to participate in the study, participants in both phases will be asked to complete baseline questionnaires either in-person, over the phone, or via a REDCap survey link to participants. After baseline assessments are completed, participants will be given an intervention manual with 9-weekly positive psychology (PP) exercises and an explanation of the exercises and intervention.

All participants in Phases 1 and 2 will be asked to complete the 9-weekly PP exercises starting after the baseline questionnaires (i.e., after the patient transplant consent visit) are completed in the pre-transplant phase and to speak with the study interventionist, a trained clinical research coordinator (CRC), weekly. Immediately after the completion of each exercise, participants will rate the ease of exercise completion, overall utility of the exercise, and their current levels of positive affect. After the Week 9 intervention phone session, all participants in both phases will complete another set of self-assessment questionnaires either over the phone, in-person at a routine clinic visit, or via a REDCap survey link emailed to participants. Additionally, participants will be asked to complete a recorded exit interview over the phone. These individual, semi-structured exit interviews will elicit feedback about the intervention (e.g., relevance and applicability of the chosen PP exercises, intervention length, timing, and delivery), study procedures, and questionnaires. Exit interviews will be recorded, transcribed, coded and thematically analyzed. At study completion, we will inquire about participants' potential interest in being contacted about our future studies.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult caregivers (≥18 years) of patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) at Dana-Farber Cancer Institute (DCFI).
• A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for HSCT.
• Ability to speak English and able to complete questionnaires with minimum assistance of an interpreter.

Exclusion Criteria:

• 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, the Brief Interview for Mental Status (BIMS) screening tool, which is sensitive and specific for screening for cognitive impairment in research subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PATH Intervention; Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.

Behavioral: Positive Psychology Intervention; Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the PATH Intervention	Feasibility of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone hematopoietic stem cell transplant (HSCT) using a single-arm trial.	9 weeks
Acceptability Rate	At the end of each weekly intervention session, acceptability was measured with ratings of ease and utility of each positive psychology exercise with a 10-point Likert scale (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability of the PATH intervention assessed by participant ratings of ease and utility on a 10 point likert scale after each weekly intervention session	Feasibility and acceptability of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone HSCT using a single-arm trial (N=20).	Up to 1 year

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Hermioni L Amonoo, MD, MPP, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hematopoietic Stem Cell Transplant; Positive Psychology Intervention; Caregivers of Patients with Cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 21-596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the study investigator at hermioni_amonoo@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No