A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02975869|
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Other: Standard Leukemia Care Other: Palliative Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Trial of a Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||December 1, 2021|
Active Comparator: Standard Leukemia Care
Standard Leukemia care
Other: Standard Leukemia Care
Experimental: Collaborative Palliative and Oncology Care
Collaborative care from Palliative Care and Leukemia will be given
Other: Palliative Care
- Comparison of Patients' quality of life as measured by (FACT-Leukemia) Score at Week-2 Between Study Arms [ Time Frame: 2 weeks ]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.
- Compare patient quality of life longitudinally using FACT-Leukemia Scores longitudinally Between Study Arms. [ Time Frame: up to 6 months ]We will compare FACT-leukemia scores longitudinally between study arm. FACT-Leukemia ranges from 0-176 with higher scores indicating better quality of life.
- Compare psychological distress (as measured by the Hospital Anxiety and Depression Scale) between Study Arms [ Time Frame: up to 6 months ]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.
- Compare Symptom Burden (as per ESAS) Between Study Arms. [ Time Frame: up to 6 months ]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.
- Compare Patient-Reported PTSD (as per PTSD-Checklist) between study arms [ Time Frame: up to 6 months ]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
- Compare Patient-Report Of Discussion EOL Care Preferences Between Study Arms [ Time Frame: up to 6 months ]We will compare patient-reported discussing their EOL care preferences between the two groups
- Compare Rates Of Chemotherapy Administration Within 30 Days Of Death Between The Two Study Arms [ Time Frame: up to 6 months ]to compare rates of chemotherapy administration near the end of life between the two arms
- Compare Rates Of Hospitalizations Within 7 Days Of Death Between The Study Arms [ Time Frame: up to 6 months ]to compare rates of hospitalizations within the last week of life between the study arms
- Compare Rates Of Hospice Utilization And Length-Of-Stay In Hospice At The EOL Between The Study Arms. [ Time Frame: up to 6 months ]to compare rates of hospice utilization and length-of-stay in hospice at the end of life between the two study arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975869
|United States, Massachusetts|
|Massachusetts general Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 16802|
|Principal Investigator:||Areej El-Jawahri, MD||Massachusetts General Hospital|