Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia

Stanford University

Status: Completed

Conditions: Acute Myeloid Leukemia

Treatments: Other: Palliative Care + Digital Symptom Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04885127

IRB-60285

NCI-2022-03013 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients being treated for a diagnosis of acute myeloid leukemia at Stanford Cancer Center
• Patients determined to be candidates for low intensity induction therapy (not requiring hospitalization to administer treatment) by their leukemia physician
• Estimated life expectancy of 6 months
• Functional status at the level of at least being capable of limited self-care, confined to chair or bed for half the day or better
• Access to smartphone, tablet, or computer with capability to utilize a symptom tracking application

Exclusion criteria

• Relapsed or refractory AML
• Patients who have established care with palliative care previously
• Non-English-speaking, as the Noona application is developed in the English language

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

All patients

Experimental group

Description:

All patients enrolled in this trial will be referred to palliative care for planned monthly virtual visits, be instructed on the use of a digital application Noona that can be downloaded on their personal electronic device, and will be prompted to fill out symptom questionnaires using Noona prior to palliative care visits (required) as well as weekly (optional).

Treatment:

Other: Palliative Care + Digital Symptom Monitoring