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

Chronic Graft-versus-host Disease Clinical Trial

— cGVHDTele-PC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458127
• Other study ID #: 24-077
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: Areej El-Jawahri, MD
• Phone: 617-724-4000
• Email: ael-jawahri[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 our prior experience with the specialty palliative care model for HCT patients, we aim to develop a telehealth specialty PC model for patients with moderate to severe cGVHD. In this single-arm pilot study, we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• cGVHD
• Chronic Graft-versus-host Disease
• Chronic GVHD
• Graft vs Host Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital (MGH)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the tele-palliative care intervention	To calculate two measures of feasibility: 1) the proportion of eligible patients who are approached and agree to participate, with 95% confidence interval, and 2) the proportion of enrolled participants who complete at least two of the three intervention visits, with 95% confidence interval.; The intervention will be deemed feasible if at least 60% of patients with moderate to severe cGVHD agree to participate in the study.; The intervention will be deemed feasible if at least 70% of participants attend at least two of the three intervention visits.	Week 12
Secondary	Acceptability of the tele-palliative care intervention	To calculate two acceptability measures: 1) the proportion of participants who score >20 on the Client Satisfaction Questionnaire (CSQ-8) with 95% confidence interval, and 2) the proportion of participants who complete the baseline and 3-month patient surveys with 95% confidence interval.; Total scores of CSQ-8 range from 8 to 32, with the higher score indicating greater satisfaction.; The proposed intervention will be deemed acceptable if at least 60% of participants score >20 on the CSQ-8.	Week 12