Acute Myeloid LeukemiaNCT04885127
Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
A study testing Palliative Care + Digital Symptom Monitoring in people with Acute Myeloid Leukemia, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Palliative Care + Digital Symptom Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
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.
Read more
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
- Being tested
- Palliative Care + Digital Symptom Monitoring
- Keywords
- Palliative Care
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care + Digital Symptom MonitoringOther
Previously described in Arm description
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Palliative Care + Digital Symptom Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, an average of 6 months
Secondary outcomes (5)
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
Measured: Baseline, 3 months, and 6 months
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
Measured: Baseline, 3 months, and 6 months
Mean change in Patient Health Questionnaire (PHQ)-9 scores
Minimum score 0, maximum score 27, with higher scores indicating worse mood
Measured: Baseline, 3 months, and 6 months
Mean change in Satisfaction with Decision-Making Scale scores
Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction
Measured: Baseline, 3 months, and 6 months
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
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start30 Mar 2022
- Primary completion30 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Kavitha Ramchandran, Stanford University
- Investigators
- Kavitha Ramchandran, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885127
- Sponsor's protocol ID
- IRB-60285
- Other IDs
- NCI-2022-03013
- Status last verified
- May 2025
- First submitted
- 1 May 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
- ClinicalTrials.gov ID
- NCT04885127
- Acronym / sponsor ID
- IRB-60285
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Other: Palliative Care + Digital Symptom MonitoringAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Care + Digital Symptom MonitoringPreviously described in Arm description | Other | All patients |
Primary outcome
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
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
5 secondary outcomes
Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores
Time frame: Baseline, 3 months, and 6 months
Mean change in Hospital Anxiety and Depression Scale (HADS) scores
Time frame: Baseline, 3 months, and 6 months
Mean change in Patient Health Questionnaire (PHQ)-9 scores
Time frame: Baseline, 3 months, and 6 months
Mean change in Satisfaction with Decision-Making Scale scores
Time frame: Baseline, 3 months, and 6 months
Overall satisfaction with usage of Noona questionnaire
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavitha Ramchandran, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care + Digital Symptom Monitoring in people with Acute Myeloid Leukemia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of completed palliative care referrals and monthly visits (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.