cGVHD, Chronic Graft-versus-host Disease, Chronic GVHD
Conditions
Keywords
Chronic graft-versus-host disease, Chronic GVHD, cGVHD, Hematopoietic stem cell transplant, Stem cell transplant, Bone marrow transplant, Telehealth, Telemedicine, Telecare, Palliative care
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.
Interventions
OTHERTele-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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the tele-palliative care intervention as measured by the proportion of eligible patients who are approached and agree to participate | Week 12 | To calculate the feasibility of the intervention using the proportion of eligible patients who are approached and agree to participate, 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. |
| Feasibility of the tele-palliative care intervention as measured by the proportion of enrolled participants who complete at least two of the three intervention visits | Week 12 | To calculate the feasibility of the intervention using 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 70% of participants attend at least two of the three intervention visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the tele-palliative care intervention as measured by the Client Satisfaction Questionnaire | Week 12 | To calculate the acceptability of the intervention using the the proportion of participants who score \>20 on the Client Satisfaction Questionnaire (CSQ-8) 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. |
Countries
United States
Outcome results
None listed