Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care + Digital Symptom Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring Palliative Care
Eligibility 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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
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).
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Mean change in Patient Health Questionnaire (PHQ)-9 scores
Minimum score 0, maximum score 27, with higher scores indicating worse mood
Mean change in Satisfaction with Decision-Making Scale scores
Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction
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
Full Information
NCT ID
NCT04885127
First Posted
May 1, 2021
Last Updated
April 4, 2022
Sponsor
Stanford University
Collaborators
Varian Medical Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04885127
Brief Title
Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
Official Title
The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
Varian Medical Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Palliative Care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Palliative Care + Digital Symptom Monitoring
Intervention Description
Previously described in Arm description
Primary Outcome Measure Information:
Title
Rate of completed palliative care referrals and monthly visits
Description
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
Time Frame
Through study completion, an average of 6 months
Title
Rate of usage of digital symptom monitoring application, Noona
Description
This will be measured by the percentage of patients who complete at least 50% of Noona surveys associated with their palliative care visits
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores
Description
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
Time Frame
Baseline, 3 months, and 6 months
Title
Mean change in Hospital Anxiety and Depression Scale (HADS) scores
Description
Hospital Anxiety and Depression survey used to measure anxiety and depression, minimum score 0, maximum score 42, with higher scores indicating increased anxiety/depression
Time Frame
Baseline, 3 months, and 6 months
Title
Mean change in Patient Health Questionnaire (PHQ)-9 scores
Description
Minimum score 0, maximum score 27, with higher scores indicating worse mood
Time Frame
Baseline, 3 months, and 6 months
Title
Mean change in Satisfaction with Decision-Making Scale scores
Description
Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction
Time Frame
Baseline, 3 months, and 6 months
Title
Overall satisfaction with usage of Noona questionnaire
Description
Measured qualitatively, by whether patients strongly agree, somewhat agree, are neutral, somewhat disagree, or strongly disagree with statements regarding the Noona instrument
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irena Tan, MD
Phone
650-498-6000
Email
irenatan@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Mannis, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kavitha Ramchandran, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irena Tan, MD
Email
irenatan@stanford.edu
First Name & Middle Initial & Last Name & Degree
Gabriel Mannis, MD
First Name & Middle Initial & Last Name & Degree
Irena Tan, MD
First Name & Middle Initial & Last Name & Degree
Kavitha Ramchandran, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
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