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

Hematologic Malignancy Clinical Trial

— PATH-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216978
• Other study ID #: 21-596
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 stem cell transplant (SCT) as treatment for their cancer, caregivers are even more crucial before, during, and after their transplantation. Although SCT 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, 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 SCT 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 SCT recipients. A scalable and accessible positive emotion based intervention tailored to the unique needs of SCT recipient caregivers provides a new line of behavioral intervention resources that could confer benefit to both caregivers and patients and could be generalizable to other cancer caregivers.

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 one-arm 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 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 would be obtained (via phone).

Upon consent to participate in the study, participants in Phase-2 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 PP exercises and an explanation of the exercises and intervention.

Participants in Phase-1 will complete the intervention after consenting for the study. All participants in Phase-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 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, participants in Phase-2 will repeat self-assessment questionnaires completed at baseline 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 the 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 30, 2024
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult caregivers (=18 years) of patients undergoing allogeneic HSCT at 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 with the Brief Interview for Mental Status (BIMS) screening tool that is sensitive and specific for screening for cognitive impairment in research subjects.

Related Conditions & MeSH terms

• Caregiver
• Hematologic Malignancy
• Hematologic Neoplasms

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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refinement of a positive psychology intervention in caregivers based on qualitative feedback of five participants	Refinement of a positive psychology intervention (PATH) in caregivers of HSCT recipients based on findings from an open-pilot study (N=5).	9 weeks after fifth participant is recruited
Secondary	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