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

NCT05216978 | Completed Results DMC

• 1 other identifier: 21-596
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver; Hematologic Malignancy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

PATH Intervention

EXPERIMENTAL

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

Interventions

Positive Psychology Intervention 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.

PATH Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Hermioni Amonoo, Director of Well-Being and Cancer Research Program
• Organization: Brigham and Women's Hospital

hermioni_amonoo@dfci.harvard.edu

‭617-525-7472‬

Study Officials

• Hermioni L Amonoo, MD, MPP, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Well-Being and Cancer Research Program

Model Details: All participants will receive the PATH intervention.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 1, 2022
• Study Start: March 1, 2022
• Primary Completion: June 8, 2023
• Study Completion: April 30, 2024
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-06

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)