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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and user-friendliness of telehealth palliative care for individuals with moderate to severe chronic graft-versus-host disease, a condition that can occur after a stem cell or bone marrow transplant. Participants will engage in monthly video calls with a palliative care specialist to manage symptoms from home. This trial suits adults diagnosed with moderate to severe chronic graft-versus-host disease who can communicate in English. As an unphased trial, it offers patients a unique opportunity to access innovative care and contribute to the advancement of telehealth solutions.

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 prior data suggests that this tele-palliative care intervention is safe for patients with chronic graft-versus-host disease?

Research has shown that tele-palliative care can improve quality of life and reduce symptom burden for patients with advanced diseases. It helps manage pain and other symptoms without causing harm. Tele-palliative care involves video calls with healthcare providers and is generally safe and well-tolerated. No reports of serious side effects exist, and patients usually find it comfortable and convenient. As a non-invasive method, it is considered safe for patients with long-term conditions like graft-versus-host disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The tele-palliative care approach for managing chronic Graft-versus-Host Disease (GVHD) is unique because it utilizes video-conferencing to bring specialized palliative care directly into patients' homes. Unlike traditional in-person visits, this method offers increased accessibility and convenience, which can be particularly beneficial for individuals dealing with the debilitating effects of moderate to severe GVHD. Researchers are excited about this treatment because it has the potential to improve quality of life by providing consistent, personalized care without the need for patients to travel, thereby reducing stress and enhancing overall well-being.

What evidence suggests that tele-palliative care is effective for chronic graft-versus-host disease?

Research shows that tele-palliative care can effectively support patients with long-term illnesses like graft-versus-host disease (GVHD). Studies indicate that palliative care improves quality of life by managing symptoms and offering emotional support. In this trial, participants with moderate to severe GVHD will receive monthly at-home consultations with a specialty palliative care clinician through video-conference telehealth visits. For patients with severe GVHD, the high risk of serious health issues underscores the need for this care. Telehealth allows patients to receive support conveniently at home, which is especially helpful for those who have difficulty moving or traveling. While it may not directly improve GVHD symptoms, the main goal is to enhance overall well-being and help patients cope better. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06458127?term=AREA%5BConditionSearch%5D(%22Chronic%20Graft%20Versus%20Host%20Disease%22)&rank=1

Tele-Palliative Care Intervention for Patients With Chronic ... This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients with moderate to ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/502275

Tele-Palliative Care Intervention for Patients With Chronic ... This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients with moderate to ...

3. jpsmjournal.com jpsmjournal.com/article/S0885-3924(23)00169-0/fulltext

Graft Versus Host Disease (GVHD) and Palliative Medicine ... No improvement in GVHD by at least one grade within 4 weeks of treatment is associated with a 6-month mortality of 45%-65%. Grade IV GVHD has mortality rates ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8198341/

Burden and Needs of Patients with Severe GvHD from the ... In this review, we summarize the current literature on the needs and burdens of patients with severe forms of graft-versus-host disease from a supportive and ...

5. cancer.jmir.org cancer.jmir.org/2023/1/e42905

Real-World European Public Social Media Listening Study Patient-reported outcomes and health status associated with chronic graft-versus-host disease. Haematologica. 2018;103(9):1535-1541. [FREE ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06458127

Tele-Palliative Care Intervention for Patients With Chronic ... This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients with moderate to ...

7. withpower.com withpower.com/trial/phase-bronchiolitis-obliterans-syndrome-6-2024-8aa89

Tele-Palliative Care for Graft-versus-Host Disease · Info for ... Research shows that tele-palliative care can improve quality of life and reduce symptom burden for patients with advanced diseases, and it also benefits ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06458127/tele-palliative-care-intervention-for-patients-with-chronic-graft-versus-host-disease

Tele-Palliative Care Intervention for Patients With Chronic ... This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients ...