AML is the most common leukemia diagnosed in adults. In spite of recent low-intensity therapies that have improved outcomes for older AML patients, AML remains associated with poor prognosis as well as high symptom burden. While the benefits of early palliative care as well as electronic PROs have been well-described in the oncology population, neither have been well-studied in the AML population, and have never been studied in combination. We propose a prospective, single-center, single-arm trial to evaluate the feasibility of a virtually-mediated supportive care model utilizing both electronic PROs and palliative care for patients with AML being treated with low-intensity therapy. AIM1: is to evaluate and describe the feasibility of implementing early specialty palliative care referrals carried out via telehealth/video-based modalities in combination with digital symptom monitoring for patients recently diagnosed with acute myeloid leukemia (AML) and starting low intensity induction therapy. AIM2: study the differences in health-related quality-of-life (HRQoL) metrics using patient-reported outcomes (PROs) in patients recently diagnosed with AML and starting low intensity induction therapy who receive early referral to telehealth/video-based palliative care visits compared to standard care. AIM3: to explore the patient experience of patients with AML on low-intensity therapy, capture rates of advance care planning, hospice utilization, and hospital utilization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Previously described in Arm description
Stanford University
Palo Alto, California, United States
Rate of completed palliative care referrals and monthly visits
This will be measured as a percentage of patients who overall complete the initial palliative care referral and at least 50% of their scheduled monthly visits
Time frame: Through study completion, an average of 6 months
Rate of usage of digital symptom monitoring application, Noona
This will be measured by the percentage of patients who complete at least 50% of Noona surveys associated with their palliative care visits
Time frame: Through study completion, an average of 6 months
Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores
Health-related quality of life instrument used in patients with acute myeloid leukemia, minimum score 0, maximum score 176, higher scores indicating worse quality of life
Time frame: Baseline, 3 months, and 6 months
Mean change in Hospital Anxiety and Depression Scale (HADS) scores
Hospital Anxiety and Depression survey used to measure anxiety and depression, minimum score 0, maximum score 42, with higher scores indicating increased anxiety/depression
Time frame: Baseline, 3 months, and 6 months
Mean change in Patient Health Questionnaire (PHQ)-9 scores
Minimum score 0, maximum score 27, with higher scores indicating worse mood
Time frame: Baseline, 3 months, and 6 months
Mean change in Satisfaction with Decision-Making Scale scores
Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction
Time frame: Baseline, 3 months, and 6 months
Overall satisfaction with usage of Noona questionnaire
Measured qualitatively, by whether patients strongly agree, somewhat agree, are neutral, somewhat disagree, or strongly disagree with statements regarding the Noona instrument
Time frame: Baseline, 6 months
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