Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458127
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-09
Brief Title:
Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
cGVHDTele-PC
Brief Summary:
This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients with moderate to severe chronic graft-versus-host disease
Detailed Description:
Chronic graft-versus-host disease cGVHD is a major cause of morbidity among survivors of allogeneic hematopoietic cell transplantation HCT patients Allogeneic HCT is a potentially curative procedure for a variety of hematologic malignancies and involves infusion of donor cells to establish marrow and immune function Recent advances in risk determination treatment ie improved safety use of a variety of donors prevention of complications and reduced-toxicity regimens have expanded the eligible patient population and increased survival of patients who undergo HCT However development of cGVHD is a leading complication of allogenic HCT and impacts over 50 of survivors It develops 3-18 months post-allogeneic HCT and is a main cause of post-HCT morbidity and mortality
cGVHD is a debilitating immunologic syndrome which attacks different organs in the body resulting in a wide range of disruptive and unpredictable symptoms Additionally side effects of cGVHD include psychological distress with many patients reporting clinical levels of depression and anxiety Further patients with cGVHD are also at high risk for late effects such as skeletal complications secondary cancers cardiovascular disease and thromboembolic events As a result of this diverse symptom burden the side effects and psychological distress from illness and uncertainty of the illness course patients living with cGVHD experience diminished QOL Patients with cGVHD struggle to manage their chronic condition exacerbated with treatment related side effects of physical symptoms functional limitations psychological distress and impaired QOL Specialty palliative care clinicians have expertise in complex symptom management facilitate coping with illness and improvement of QOL in cancer patients Telehealth in various forms has been long studied as an approach to increase access to care and a care model for management of chronic diseases Expanding on prior experience with the specialty palliative care model for HCT patients the investigators aim to develop a telehealth specialty PC model for patients with moderate to severe cGVHD In this single-arm pilot study the investigators will test the feasibility and acceptability of a once a month tele-palliative care appointment over the course of 3 months to address the symptom burden psychological distress and disease uncertainty of cGVHD patients
cGVHD is a debilitating immunologic syndrome which attacks different organs in the body resulting in a wide range of disruptive and unpredictable symptoms Additionally side effects of cGVHD include psychological distress with many patients reporting clinical levels of depression and anxiety Further patients with cGVHD are also at high risk for late effects such as skeletal complications secondary cancers cardiovascular disease and thromboembolic events As a result of this diverse symptom burden the side effects and psychological distress from illness and uncertainty of the illness course patients living with cGVHD experience diminished QOL Patients with cGVHD struggle to manage their chronic condition exacerbated with treatment related side effects of physical symptoms functional limitations psychological distress and impaired QOL Specialty palliative care clinicians have expertise in complex symptom management facilitate coping with illness and improvement of QOL in cancer patients Telehealth in various forms has been long studied as an approach to increase access to care and a care model for management of chronic diseases Expanding on prior experience with the specialty palliative care model for HCT patients the investigators aim to develop a telehealth specialty PC model for patients with moderate to severe cGVHD In this single-arm pilot study the investigators will test the feasibility and acceptability of a once a month tele-palliative care appointment over the course of 3 months to address the symptom burden psychological distress and disease uncertainty of cGVHD patients
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