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| For Patients and
Family Members |
What
is a HEMATOLOGIST?
What
is a MEDICAL ONCOLOGIST?
What
is a RADIATION ONCOLOGIST?
What
is a RADIATION THERAPIST?
What
is an ONCOLOGY NURSE, OR NURSE ONCOLOGIST?
What
is a CLINICAL RESEARCH ASSOCIATE (CRA)?
GLOSSARY
PHASES
OF CLINICAL TRIALS
What is a HEMATOLOGIST?
A Hematologist specializes in diagnosing and treating diseases
of the blood, bone marrow, and lymph nodes. Some common diseases
treated by a Hematologist include various types of anemia and
leukemia, various lymphomas, including Hodgkin's Disease. Hematologists
do give chemotherapy and usually oversee bone marrow and stem
cell transplantations.
What is a MEDICAL ONCOLOGIST?
A Medical Oncologist specializes in diagnosing and treating
"solid tumor" cancers of all kinds. Some examples include breast
cancer, colon cancer, and lung cancer. Medical Oncologists do
prescribe chemotherapy and monitor the patients for side effects
from the drugs. They do work with the Hematologists, and some
have a dual specialty of both Hematology and Medical Oncology.
What is a RADIATION ONCOLOGIST?
A Radiation Oncologist is a physician who specializes in
treating cancer patients with radiation. In some cases, the
treatment may be for solid tumors, and in other cases, radiation
is given to alleviate symptoms of cancer, such as bone pain.
Radiation Oncologists do not give chemotherapy, but they do
work closely with the Medical Oncologist or Hematologist to
provide the best care and treatment possible for the patient.
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What is a RADIATION THERAPIST?
A Radiation Therapist is a person specially trained to
administer the radiation treatment, and to monitor for side
effects of radiation. This person works closely with the Radiation
Oncologist to assure that the radiation being given is delivered
accurately and with minimal trauma to surrounding areas of the
patient.
What is an ONCOLOGY NURSE, OR NURSE ONCOLOGIST?
An Oncology Nurse is a RN who specializes in the care of
patients with cancer. This person works directly with the Hematologist,
Medical Oncologist, and Radiation Oncologist to ensure that
the needs of the cancer patient are met. The Oncology Nurse
has special training in the management of side effects associated
with the treatment of cancer. Oncology Nurses administer chemotherapy
prescribed by the physician. Many Oncology Nurses are trained
in carrying out the documentation of the specific requirements
involved in clinical trials and clinical research studies.
What is a CLINICAL RESEARCH ASSOCIATE
(CRA)?
A Clinical Research Associate, or CRA, is an individual
with special training in the field of research. This person's
primary responsibility is to view the medical records of those
patients enrolled in clinical trials and to complete required
data forms using the patient's medical record. This person also
ensures that federal guidelines surrounding the conduction of
clinical research are utilized. This person's job is critical
to the successful interpretation of the data needed from doing
the clinical trial, and certainly, to the outcome of results
of the trials. Many CRAs work behind the scene in the cancer
center where you are receiving your treatment. However, it is
becoming more common to have CRAs work closely with the patient,
doctor, and nurse, to ensure that all required clinical trial
data is accurately captured.
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GLOSSARY
This glossary contains a list of words used on this web site
and their definitions. It also explains some other terms related
to research studies that you might hear being used by your doctor
or nurse.
Adjuvant Treatment: the treatment given to a patient
after the initial cancer diagnosis. Adjuvant treatment normally
follows a surgical procedure, and is usually the first treatment
given to a cancer patient, unless the patient has been diagnosed
with advanced disease.
Advanced Disease: disease that has spread beyond the
original spot in the body.
Bias: Human choices or any other factors beside the treatments
being tested that affect a study's results. Clinical trials
use many methods to avoid bias, because biased results may not
be correct.
Clinical Trials: Research studies that involve people.
Each study tries to answer scientific questions and to find
better ways to prevent or treat cancer.
Control Group: In a clinical trial, the group of people
that receive standard treatment for their cancer.
Double Blind Study: A method used to prevent bias in
treatment studies. In a double blind study, the patient is not
told whether he/she is taking the standard treatment, a new
treatment, or a placebo. All medications are produced to look
alike. The doctor does not know either what treatment the patient
is receiving. Methods are in place to "unblind" the treatment
in the event of a serious side effect.
Informed Consent: The process in which a person learns
key facts about a clinical trial or research study and then
agrees voluntarily to take part or decides against it. This
process includes signing a form that describes the benefits
and risks that may occur if the person decides to take part.
Institutional Review Board (IRB): Groups of scientists,
doctors, clergy, and consumers at each health care facility
at which a clinical trial takes place. Designed to protect patients
who take part in studies, IRBs review and must approve the protocols
for all clinical trials funded by the federal government. They
check to see that the study is well designed, does not involve
undue risks, and includes safeguards for patients.
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Investigator: A researcher in a treatment study. Often,
this is an Oncologist.
Metastasis: spread of cancer to other body areas.
Measurable Disease: Disease that can be measured by clinical
means. For example, a tumor in the lung on a chest xray can
be measured using a ruler. Measurements are taken before each
treatment to evaluate the tumor response to treatment.
Neoadjuvant Therapy: either chemotherapy or radiation
therapy given to shrink a tumor before going to surgery to remove
it.
Oncologist: A doctor who specializes in treating cancer.
Placebo: A tablet, capsule, or injection that looks like
the drug or other substance being tested but contains no drug.
Protocol: An action plan for a clinical trial. The plan
states what will be done in the study and why. It outlines how
many people will take part in the study, what types of patients
may take part, and what tests they will receive and how often,
and the treatment plan.
Randomization: A method used to prevent bias in research.
People are assigned by chance to either the treatment or control
group.
Remission: When the signs and symptoms of cancer go away,
the disease is said to be "in remission" A remission can be
temporary or permanent.
Side Effects: Problems that occur when treatment affects
healthy cells. Common side effects of standard cancer treatment
are fatigue, nausea, vomiting, decreased blood cell counts,
hair loss, and mouth sores. New treatments being tested may
have these or other unknown side effects.
Single-Blind Study: A method used to prevent bias in
treatment studies. In a single-blind study, the patient is not
told whether he/she is taking the standard treatment or the
new treatment being tested. Only the doctor knows.
Stage: The extent of a cancer and whether the disease
has spread from the original site to other parts of the body.
Standard Treatment: The best treatment currently known
for a cancer, based on results of past research.
Treatment Group: The group that receives the new treatment
being tested during a study.
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PHASES OF CLINICAL TRIALS
PHASE I Trials are the first step in testing a new treatment
in humans. In these studies researchers look for the best way
to give a new treatment. They also try to find out if and how
the treatment can be given safely and they watch for any harmful
side effects. Because less is known about the possible risks
and benefits in Phase I, these studies usually include only
a limited number of patients who would not be helped by other
known treatments.
PHASE II Trials focus on learning whether the new treatment
has an anticancer effect. As in Phase I, only a small number
of people take part because of the risks and unknowns involved.
PHASE III Trials compare the results of people taking
the new treatment with results of people taking standard treatment.
In most cases, studies move into Phase III testing only after
a treatment shows promise in Phases I and II. Phase III trials
may include hundreds of people around the country. In
Phase III trials, people are assigned at random by a computer
to receive either the new treatment or standard treatment by
a process known as randomization.
Phase IV trials are conducted to continue the evaluation
of the safety and efficacy of cancer therapies that are already
approved and available for use.
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