Leukemia, Promyelocytic, Acute Clinical Trial
Official title:
Assessing the Impact of a Simplified Patient Care Strategy to Decrease Early Deaths In Acute Promyelocytic Leukemia (APL) By Maintaining A Database
Acute promyelocytic leukemia (APL) is a very rare type of leukemia. Because it is so rare,
many doctors do not have experience treating it. APL has been shown to be curable most of the
time. Unfortunately, some patients die early after they become sick with APL, sometimes even
before starting treatment. The early period is from the time of diagnosis through the first
treatments for the disease. This is approximately 30 days. Early deaths are often due to
complications caused by of the effects of leukemia and the treatments of it. These
complications may not be noticed quickly by doctors who don't have much experience with
managing APL.
The purpose of this study is to collect information about the diagnosis and management of APL
patients by review of their medical records. This information will be stored in a central
database at Emory University. This data will be analyzed to discover the impact of increased
physician knowledge of recommended management of APL. The goal is to reduce the events of
early death of APL patients.
The investigators propose to collect data on patients with APL treated predominantly across
the states of Georgia and South Carolina but will also extend it to cover patients from
neighboring states. The treatment will be as per the treating physician and would be standard
of care and no new drugs or changes to standard of care are being proposed in educating the
treating physicians.
This is a multi-center study. At the lead sites, patients will sign the consent form and data
will be collected at those respective sites. The sites outside of Emory are centers in the
catchment area that treat leukemia. The lead investigators are available around the clock to
co-manage the APL patients.
The objective of the study is to collect data to assess for improvement in mortality at the
primary centers as well as at the local treatment centers. This change in mortality would
depend on educating the community physicians and nursing staff and requires regular visits
both by the physicians and the nurse coordinator. The community hematologists/oncologists in
the catchment area will be educated by sending emails from investigators at 3 month intervals
to inform them of the high early death rate associated with APL. In addition, a brief
pamphlet will be mailed to them once every 3 months as a reminder. The lead investigators in
each state will make presentations in regional meetings, visit practices, and also call local
practices. In addition, a nurse coordinator will be instrumental in calling upon nursing
staff in outlying hospitals in the catchment area to apprise them of early deaths in APL and
also make them aware of the study and resources available. This will be done aggressively
during the first 6 months prior to initiating the trial and will be continued during the
three-year study period.
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