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N/A N=23 Supportive Care

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

Caregiver · Hematologic Malignancy

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Feasibility of the PATH Intervention — 15; 13; 15 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Positive Psychology Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Brigham and Women's Hospital
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Feasibility of the PATH Intervention
15; 13; 15
PRIMARY
Acceptability Rate
8.1; 8.3

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05216978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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