Chronic Graft-versus-host Disease Clinical Trial
— cGVHDTele-PCOfficial title:
Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital (MGH) | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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 |
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