Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease

NCT ID: NCT06458127

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2027-01-30

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 (i.e., 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.

Conditions

Chronic Graft-versus-host Disease; Chronic GVHD; cGVHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tele-PC Intervention

Participants (individuals with moderate to severe chronic Graft-versus-Host Disease) will receive a monthly at home consultation with a specialty palliative care clinician via a video-conference tele-health visit.

Group Type: EXPERIMENTAL

Tele-palliative care visit

Intervention Type: OTHER

Participants will meet with a specialty palliative care clinician for a video-consultation once a month, and complete three tele-PC consultations in total over a three-to-four-month period. They will also complete self-report assessments at baseline and immediately after the last PC intervention visit, approximately 3-4 months after enrolment.

Interventions

Tele-palliative care visit

Participants will meet with a specialty palliative care clinician for a video-consultation once a month, and complete three tele-PC consultations in total over a three-to-four-month period. They will also complete self-report assessments at baseline and immediately after the last PC intervention visit, approximately 3-4 months after enrolment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1) Adult patients (>18 years)
• 2) Have moderate to severe cGVHD based on their oncology clinician assessment as documented in the electronic health record.
• 3) Ability to comprehend and speak English, and to read and respond to questions in English

Please note that this is a proof-of-concept study, and we only include patients who comprehend, read, and respond to questions in English since the study instruments are all available in English. However, as we have done in prior studies, we will expand the population in a future efficacy trial.

Exclusion Criteria

• 1) Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures
• 2) Patients who have already consulted or are currently consulting palliative care

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

24-077

Identifier Type: -

Identifier Source: org_study_id