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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-03013 | Registry Identifier | CTRP |
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care + Digital Symptom Monitoring | Other | Previously described in Arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months, and 6 months |
| Mean change in Hospital Anxiety and Depression Scale (HADS) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kavitha Ramchandran, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Hospital Anxiety and Depression survey used to measure anxiety and depression, minimum score 0, maximum score 42, with higher scores indicating increased anxiety/depression |
| 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 | 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 | 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 | Baseline, 6 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |