Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing HSCT

NCT ID: NCT05216978

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-04-30

Brief Summary

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.

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.

Conditions

Caregiver; Hematologic Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Positive Psychology Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hermioni L.Amonoo, MD, MPP, MPH

Director, Well-Being and Cancer Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hermioni L Amonoo, MD, MPP, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-596

Identifier Type: -

Identifier Source: org_study_id