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

NCT04885127 | Completed DMC

• 2 other identifiers: IRB-60285NCI-2022-03013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores

  Baseline, 3 months, and 6 months

• Mean change in Hospital Anxiety and Depression Scale (HADS) scores

  Baseline, 3 months, and 6 months

• Mean change in Patient Health Questionnaire (PHQ)-9 scores

  Baseline, 3 months, and 6 months

• Mean change in Satisfaction with Decision-Making Scale scores

  Baseline, 3 months, and 6 months

• Overall satisfaction with usage of Noona questionnaire

  Baseline, 6 months

Study Arms (1)

All patients

EXPERIMENTAL

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).

Other: Palliative Care + Digital Symptom Monitoring

Interventions

Palliative Care + Digital Symptom Monitoring OTHER

Previously described in Arm description

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kavitha Ramchandran, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Medicine - Oncology

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 13, 2021
• Study Start: March 30, 2022
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)