Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153797
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-11-23
Brief Title:
A Positive Psychology Based Intervention PATH-C for Caregivers of HSCT Survivors
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Randomized Controlled Trial of a Positive Psychology Based Intervention PATH-C for Caregivers of Hematopoietic Stem Cell Transplant Survivors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATH-C
Brief Summary:
The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention PATH-C can improve psychological well-being quality of life and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation HSCT
Detailed Description:
Family and friend caregivers are vital care providers throughout the entire care continuum for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation HSCT These caregivers must manage multiple time-consuming responsibilities including monitoring vital signs and side effects of treatment administering medications and coordinating transportation to and from medical appointments The substantial caregiving burden among caregivers of patients undergoing HSCT is associated with increased symptoms of depression anxiety and fatigue Symptoms such as fatigue and depression in HSCT caregivers may undermine attempts to maintain regular physical activity routines which may impact essential health outcomes such as cardiovascular health
With persistent shortages in the mental health workforce needed to address these psychological needs of HSCT caregivers adequately remotely-delivered psychosocial interventions offer an innovative approach to overcome the unmet psychological needs of this population Hence the investigators developed a remotely-delivered positive psychology intervention Positive Affect in the Transplantation of Hematopoietic Stem Cells for Caregivers PATH-C tailored to the unique psychological needs of HSCT caregivers With this study the investigators will establish the impact of PATH-C on participant-reported outcomes compared to usual care
The study will use validated questionnaires to measure caregivers quality of life caregiver burden psychological distress symptoms positive psychological well-being eg positive affect gratitude and self-management targets eg coping self-efficacy The study will also use the validated ActiGraph GT3X accelerometer to measure minutesday of moderate-to-vigorous physical activity light activity and sedentary leisure time
With persistent shortages in the mental health workforce needed to address these psychological needs of HSCT caregivers adequately remotely-delivered psychosocial interventions offer an innovative approach to overcome the unmet psychological needs of this population Hence the investigators developed a remotely-delivered positive psychology intervention Positive Affect in the Transplantation of Hematopoietic Stem Cells for Caregivers PATH-C tailored to the unique psychological needs of HSCT caregivers With this study the investigators will establish the impact of PATH-C on participant-reported outcomes compared to usual care
The study will use validated questionnaires to measure caregivers quality of life caregiver burden psychological distress symptoms positive psychological well-being eg positive affect gratitude and self-management targets eg coping self-efficacy The study will also use the validated ActiGraph GT3X accelerometer to measure minutesday of moderate-to-vigorous physical activity light activity and sedentary leisure time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None