Acute Myeloid Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic Syndromes, Myelofibrosis, Myeloid Malignancy
Conditions
Keywords
Older adults, Myeloid malignancies, Geriatric hematology, Serious illness conversations
Brief summary
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.
Detailed description
The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.
Interventions
BEHAVIORALTelehealth Serious Illness Care Program
The 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).
OTHEREducation Control
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion and
Exclusion criteria
for Patients Inclusion criteria: * 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 * English-speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Communication: Health Care Climate Questionnaire | Month 2 | 5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress: Distress Thermometer | Month 2 | 1-item question for distress, range 0-10; higher scores indicate greater distress |
| Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7) | Month 2 | 7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms |
| Completion of advance directives | Throughout the study, up to 2 years | 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 |
Countries
United States
Contacts
CONTACTKah Poh Loh, MD
CONTACTBecky Gravenstede
PRINCIPAL_INVESTIGATORKah Poh Loh
University of Rochester
Outcome results
None listed