AML-084: Feasibility Study Integrating Electronic Patient-Reported Outcomes (PROs) and Palliative Care for High-Risk Acute Myeloid Leukemia (AML) Patients

Abstract

Context: Despite recent lower-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 and electronic PROs have been well-described in oncology patients, neither have been well-studied in AML, and they have never been studied in combination. Objective: 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 lower-intensity therapy (NCT04885127). Design: This will be a prospective, single-arm, non-blinded trial with a year of enrollment and six months of follow-up. Setting: All patients will be enrolled at Stanford Comprehensive Cancer Center. Patients or Other Participants: We plan on enrolling 40 patients who are on first-line lower-intensity therapy for AML, defined as therapy that allows patients to receive care exclusively in the outpatient setting. Interventions: Patients who are enrolled will be referred to the subspecialty palliative care clinic for virtual consultation and monthly follow-up visits for 6 months. Patients will also be instructed on the use of Noona, a digital application that allows real-time, remote monitoring of PROs. Patients will be requested to fill out a Noona symptom questionnaire prior to each palliative care visit and will be prompted to maintain a weekly symptom diary, which will be available to both their primary leukemia and palliative care providers. They will also fill out health-related quality of life surveys, including Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu), Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9 (PHQ-9), and Satisfaction with Decision-Making Scale, at baseline, three, and six months. Main Outcome Measures: The primary outcome to be measured at completion of the study will be the feasibility of palliative care referral, defined as completion of the initial virtual consultation and at least 50% of the six scheduled monthly follow-up visits. Secondary outcomes will include the proportion of patients who complete the digital symptom questionnaires and the proportion of patients who complete their health-related quality of life surveys. Scores obtained from surveys will be used to generate hypotheses for future work. Despite recent lower-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 and electronic PROs have been well-described in oncology patients, neither have been well-studied in AML, and they have never been studied in combination. 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 lower-intensity therapy (NCT04885127). This will be a prospective, single-arm, non-blinded trial with a year of enrollment and six months of follow-up. All patients will be enrolled at Stanford Comprehensive Cancer Center. We plan on enrolling 40 patients who are on first-line lower-intensity therapy for AML, defined as therapy that allows patients to receive care exclusively in the outpatient setting. Patients who are enrolled will be referred to the subspecialty palliative care clinic for virtual consultation and monthly follow-up visits for 6 months. Patients will also be instructed on the use of Noona, a digital application that allows real-time, remote monitoring of PROs. Patients will be requested to fill out a Noona symptom questionnaire prior to each palliative care visit and will be prompted to maintain a weekly symptom diary, which will be available to both their primary leukemia and palliative care providers. They will also fill out health-related quality of life surveys, including Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu), Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9 (PHQ-9), and Satisfaction with Decision-Making Scale, at baseline, three, and six months. The primary outcome to be measured at completion of the study will be the feasibility of palliative care referral, defined as completion of the initial virtual consultation and at least 50% of the six scheduled monthly follow-up visits. Secondary outcomes will include the proportion of patients who complete the digital symptom questionnaires and the proportion of patients who complete their health-related quality of life surveys. Scores obtained from surveys will be used to generate hypotheses for future work.