Tele-Palliative Care for Graft-versus-Host Disease

(cGVHDTele-PC Trial)

Overseen By Upeka Samarakoon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Acute psychiatric, Cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Tele-palliative care visit for Graft-versus-Host Disease?

Research shows that tele-palliative care can improve quality of life and reduce symptom burden for patients with advanced diseases, and it also benefits caregivers by improving mood and reducing burden. While specific data for Graft-versus-Host Disease is not available, these findings suggest potential benefits for similar conditions. ^{1 2 3 4 5}

How does the treatment Tele-palliative care visit differ from other treatments for graft-versus-host disease?

Tele-palliative care visits offer a unique approach by using virtual consultations to provide palliative care, which can improve access to care and reduce stress for patients and caregivers by eliminating the need for travel. This method is particularly beneficial for those in remote areas or with limited access to specialized care, making it different from traditional in-person treatments. ^{3 5 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with moderate to severe chronic graft-versus-host disease (cGVHD) as assessed by their oncologist. Participants must understand and speak English well enough to answer questions. Those with acute psychiatric or cognitive conditions, or who are already in palliative care, cannot join.

Inclusion Criteria

My doctor has diagnosed me with moderate to severe chronic graft-versus-host disease.

I am over 18 years old.

Exclusion Criteria

Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures

I am currently receiving or have received palliative care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tele-Palliative Care Intervention

Participants receive a monthly at-home consultation with a specialty palliative care clinician via video-conference tele-health visit

12 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Tele-palliative care visit

Trial Overview The study is testing the use of telehealth for providing palliative care to patients suffering from cGVHD. It aims to determine how practical and acceptable it is for patients to receive this type of remote healthcare service.

Participant Groups

Group I: Tele-PC Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Telehealth applications have been found effective in delivering palliative care to patients in remote and rural communities, improving symptom management and quality of life based on a review of 18 studies involving over 3,300 patients.

Despite the positive outcomes, the studies revealed significant biases and limitations, indicating a need for more rigorous research to establish best practices for virtual palliative care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Telehealth for Delivery of Palliative Care to Remote Communities: A Rapid Review. Gordon, B., Mason, B., Smith, SLH.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of Tele-palliative Care on Patient and Caregiver Outcomes: A Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Leveraging Telehealth for Delivery of Palliative Care to Remote Communities: A Rapid Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

How outpatient palliative care teleconsultation facilitates empathic patient-professional relationships: a qualitative study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

The effect of weekly specialist palliative care teleconsultations in patients with advanced cancer -a randomized clinical trial. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Providing Palliative Care to Patients Throughout the State of Indiana from a Centralized Virtual Palliative Care Hub. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Web-based videoconferencing for rural palliative care consultation with elderly patients at home. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Telemedicine in Palliative Care: Digital Communication in a Relationship-Based Speciality - Does It Make Sense?] [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Integrating Palliative Care in Hematopoietic Stem Cell Transplantation: A Qualitative Study Exploring Patient, Caregiver, and Clinician Perspectives. [2023]