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NCT04885127 | RECRUITING | Acute Myeloid Leukemia

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

Condition or disease

Acute Myeloid Leukemia

Intervention/treatment

Palliative Care + Digital Symptom Monitoring

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
Actual Study Start Date : 2022-03-30
Estimated Primary Completion Date : 2024-03-30
Estimated Study Completion Date : 2024-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia

Location Details

NCT04885127

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How to Participate

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Locations

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94304