Clinical trial NCT04885127: Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
Official title: The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Palliative Care
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems, Inc.
First posted: 2021-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of completed palliative care referrals and monthly visits
timeFrame: Through study completion, an average of 6 months
measure: Rate of usage of digital symptom monitoring application, Noona
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores
timeFrame: Baseline, 3 months, and 6 months
measure: Mean change in Hospital Anxiety and Depression Scale (HADS) scores
timeFrame: Baseline, 3 months, and 6 months
measure: Mean change in Patient Health Questionnaire (PHQ)-9 scores
timeFrame: Baseline, 3 months, and 6 months
measure: Mean change in Satisfaction with Decision-Making Scale scores
timeFrame: Baseline, 3 months, and 6 months
measure: Overall satisfaction with usage of Noona questionnaire
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Gabriel Mannis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Kavitha Ramchandran, MD
role: STUDY_CHAIR
References: