About this trial
The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Age ≥60 years
A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
Being managed in the outpatient settings
Able to provide informed consent
Trial design
Parallel
Treatments tested in this trial
Telehealth Serious Illness Care Program
BehavioralThe adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).
Education Control
Other interventionEducation materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Treatment groups
Trial outcomes
Primary outcomes
Healthcare Communication: Health Care Climate Questionnaire
5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better
Secondary outcomes
Distress: Distress Thermometer
1-item question for distress, range 0-10; higher scores indicate greater distress
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)
7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms
Completion of advance directives
Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion
Sponsors and contacts
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