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

Acute Myeloid Leukemia Clinical Trial

Official title:

The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885127
• Other study ID #: IRB-60285
• Secondary ID: NCI-2022-03013
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Irena Tan, MD
• Phone: 650-498-6000
• Email: irenatan[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Palliative Care + Digital Symptom Monitoring
Previously described in Arm description

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Varian Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 6 months
Primary	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	Through study completion, an average of 6 months
Secondary	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	Baseline, 3 months, and 6 months
Secondary	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	Baseline, 3 months, and 6 months
Secondary	Mean change in Patient Health Questionnaire (PHQ)-9 scores	Minimum score 0, maximum score 27, with higher scores indicating worse mood	Baseline, 3 months, and 6 months
Secondary	Mean change in Satisfaction with Decision-Making Scale scores	Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction	Baseline, 3 months, and 6 months
Secondary	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	Baseline, 6 months