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

Not Applicable

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Palliative Care + Digital Symptom Monitoring

• Registration Number: NCT04885127
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-13
• Study Start: 2022-03-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-03-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Palliative Care + Digital Symptom Monitoring	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).

Primary Outcome Measures

Name	Time	Method
Rate of usage of digital symptom monitoring application, Noona	Through study completion, an average of 6 months	This will be measured by the percentage of patients who complete at least 50% of Noona surveys associated with their palliative care visits
Rate of completed palliative care referrals and monthly visits	Through study completion, an average of 6 months	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

Secondary Outcome Measures

Name	Time	Method
Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores	Baseline, 3 months, and 6 months	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
Mean change in Hospital Anxiety and Depression Scale (HADS) scores	Baseline, 3 months, and 6 months	Hospital Anxiety and Depression survey used to measure anxiety and depression, minimum score 0, maximum score 42, with higher scores indicating increased anxiety/depression
Mean change in Satisfaction with Decision-Making Scale scores	Baseline, 3 months, and 6 months	Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction
Overall satisfaction with usage of Noona questionnaire	Baseline, 6 months	Measured qualitatively, by whether patients strongly agree, somewhat agree, are neutral, somewhat disagree, or strongly disagree with statements regarding the Noona instrument
Mean change in Patient Health Questionnaire (PHQ)-9 scores	Baseline, 3 months, and 6 months	Minimum score 0, maximum score 27, with higher scores indicating worse mood

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States