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| Name | Class |
|---|---|
| Duke University | OTHER |
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This research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
The main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with AML undergoing treatment.
The investigators aim to find out whether introducing patients and families undergoing AML treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Leukemia Care | Active Comparator | Standard Leukemia care |
|
| Collaborative Palliative and Oncology Care | Experimental | Collaborative care from Palliative Care and Leukemia will be given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Leukemia Care | Other |
| ||
| Palliative Care |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms | We will compare patients' FACT-Leukemia scores at week-2 adjusting for baseline scores. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms. | We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life. | up to 6 months |
| Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts general Hospital | Boston | Massachusetts | 02114 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38429079 | Derived | Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804. | |
| 33331857 | Derived | El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb JA, Jackson VA, Campbell TC, O'Connor N, Luger SM, Gafford E, Gustin J, Bhatnagar B, Walker AR, Fathi AT, Brunner AM, Hobbs GS, Nicholson S, Davis D, Addis H, Vaughn D, Horick N, Greer JA, Temel JS. Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2021 Feb 1;7(2):238-245. doi: 10.1001/jamaoncol.2020.6343. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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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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We will compare patients' psychological distress using the HADS between study arms at week-2 and longitudinally between study arms. The HADS consistent of two subscales assessing anxiety and depression symptoms with scores ranging from 0-21 with higher scores indicating worse psychological distress. |
| up to 6 months |
| Compare Symptom Burden (as per ESAS) Between Study Arms. | We will compare patients' symptom burden using the Edmonton Symptom Assessment Scale (ESAS) between the two arms at week-2 and longitudinally. The ESAS ranges from 0-100 with higher scores indicating worse symptom burden. | up to 6 months |
| Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms | We will compare PTSD symptoms as measured by the PTSD-Checklist (PCL) between the two groups at week-2 and longitudinally. PCL scores range from 17-85 with higher scores indicating worse PTSD symptoms | up to 6 months |
| Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms | We will compare patient-reported discussing their EOL care preferences between the two groups | up to 6 months |
| Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms | to compare rates of chemotherapy administration near the end of life between the two arms | up to 6 months |
| Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms | to compare rates of hospitalizations within the last week of life between the study arms | up to 6 months |
| Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms. | to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms | up to 6 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 16802 | United States |
| D006425 |
| Hemic and Lymphatic Diseases |