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NCT Number: NCT04885127

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Care + Digital Symptom Monitoring

Other

Previously described in Arm description

Primary outcomes

  1. Rate of completed palliative care referrals and monthly visits

    Time frame: 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

  2. Rate of usage of digital symptom monitoring application, Noona

    Time frame: 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

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: Baseline, 3 months, and 6 months

    Minimum score 0, maximum score 27, with higher scores indicating worse mood

  4. Mean change in Satisfaction with Decision-Making Scale scores

    Time frame: Baseline, 3 months, and 6 months

    Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction

  5. Overall satisfaction with usage of Noona questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 13, 2021
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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