by Hilary Wright
Once a diagnosis of breast cancer has been made, fear and
desperation may begin to take over the emotions of both caregiver
and loved one. The most important thing that can been done by both
of you is to immediately take back control from the disease through
education and knowledge. Not only will this lead to a feelings of
empowerment, but there will also be feelings of optimism and hope
that might have otherwise been eluded. After you’ve done your
research on the type of breast cancer your loved has, you can begin
the research process of looking into what are known as clinical
trials. Unless personally touched by a major, medical dilemma, most
people will never hear about clinical trials. For a caregiver and
their loved one, a clinical trial can possibly make the difference
between life and death, or, at the very least, it can be an
extension of time.
In order to clarify any confusion, clinical trials are often
referred to in a number of
other terms by the members of the medical-scientific community, such
as clinical study, research protocol, or medical research, all
meaning the same thing ... clinical trial. The National Cancer
Institute (NCI) defines a cancer clinical trial as "an organized
study conducted in people with cancer to answer specific questions
about a new treatment or a new way of using an old treatment." The
process of finding out about an appropriate clinical trial for a
loved one usually begins by discussing the possibility with their
oncologist (cancer specialist). The National Cancer Institute (NCI)
sponsors this comprehensive service, where more than 1,500 clinical
trials are available from their database. You can also receive the
same information online at NCI’s web site,
www.cancer.gov Yet
another route you can goin getting information about breast cancer
clinical trials is through contacting the pharmaceutical companies
directly. Phone numbers for these companies can be found in the
Physician’s Desk Reference book which is available through most
public libraries. Once you and your loved one have decided upon a
particular clinical trial, and feel it could prove beneficial, a few
more factors must be considered which may still affect whether your
loved one will want to participate or not.
Every clinical trial has its own guidelines for who is eligible to
be a part of the study.
Generally, participants are alike in several ways, either having in
common the same type and stage of cancer, age, gender, or previous
treatments. Eligibility criteria are generally included in the study
plan, and you can find out if your loved one is eligible for a
particular study by talking to their doctor or to the doctor or
nurse in charge of enrolling patients in the study. Cancer clinical
trials may consist of a little bit of everything, and can be found
to exist in different formats, like:
Treatment trials: where new treatments for
cancers are tested, including new drugs, new approaches in
surgery or radiation therapy, or a new combination of treatments
or methods, such as gene therapy or immune therapy.
Prevention trials: tests new medicines, vitamins, minerals, or
other supplements which may lower the risk of certain types of
cancer. These trials look for ways to either prevent cancer in
people who have never had it, to prevent cancer from coming
back, or prevent a new form of cancer from occurring in people
who already have cancer.
Screening trials: this tests for the best ways to find cancer,
especially in its’ earliest stages.
Quality of Life trials: also called Supportive Care trials, ways
are explored to improve comfort and quality of life for cancer
patients.
It must be understood that if your loved one is
found to be eligible for a clinical trial that is for a new cancer
drug, the clinical research will involve a series of steps referred
to as “phases” in order to test the new drug. These phases allow
researchers to ask and answer questions that will result in reliable
information about the drug, as well as protection for your loved
from any possible problems. Clinical trials are usually classified
into one of three phases:
Phase I trials: These are the first studies
in which people are evaluated on how a new drug should best be
administered (by mouth, injected into the blood, or injected
into the muscle), how often, and what dose is considered to be
safe. Usually only a small number of patients are enrolled in
this phase, sometimes as few as a dozen.
Phase II trials: A phase II trial continues to test the safety
of a drug, and begins to evaluate how well the new drug works.
Phase II studies usually focus on a particular type of cancer.
Phase III trials: test a new drug, a new combination of drugs,
or a new surgical procedure in comparison to the current
standard. A participant will usually be assigned to the standard
group or the new group at random (called randomization). This
phase often enrolls large numbers of people and may be conducted
at many doctors' offices, clinics, and cancer centers
nationwide.
In order to assure the safety of those who are
about to undergo a clinical trial, the
government has designed a system that requires a trial plan, known
as the protocol, to first be approved. After approval, a review
committee is then assigned to the clinical trial in order to
continually monitor the study, making sure that the original
protocol is being followed and that the participants are being
protected. Government regulations also require a patient to go
through a process called “informed consent” prior to deciding
whether or not they want to participate in a specific clinical
trial. Informed consent is when researchers performing the study
thoroughly inform patients about the treatments and tests, and what
the possible benefits and risks will be. Along with talking with the
research doctor or nurse, a written consent form will also be given
to take home to read and discuss. The consent form will include
details about:
- the approach of the study
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have to undergo
Remember to continually ask questions until
satisfied that all the information needed is understood. Although
informed consent begins prior to your loved one agreeing to
participate in the clinical trial, always feel free to ask the
healthcare team any questions at any point. Informed consent
continues as long as your loved one is involved with the study. A
participant has the right to change their mind and leave the
clinical trial whenever they want, whether it’s before the study
starts, during the actual study or during the follow-up period.
Clinical trials are conducted in a number of places, including large
cancer centers,
university hospitals, at local medical centers, or at a doctor's
office. Depending upon the type of clinical trial and based on the
intervention it's designed to study, the trial may include
participants at one or two highly specialized centers, or it may
involve hundreds of locations at the same time. Clinical trials are
conducted under the guidance of a healthcare team which includes
your loved one’s doctor, along with other health professionals. The
information from all the participants is then used by experts who
evaluate the intervention that the trial is testing.
Deciding upon whether or not your loved one becomes a participant in
a cancer clinical trial is completely up to them. However, there are
some very important questions you and your loved one both should get
answered:
- What is the purpose of the study?
- Why do researchers think the approach may be effective?
- Who will sponsor the study?
- Who has reviewed and approved the study?
- How are study results and safety of participants being
checked?
- How long will the study last?
- What will the responsibilities be if I participate?
- What are the possible short-term benefits?
- What are the possible long-term benefits?
- What are the short-term risks, such as side effects?
- What are the possible long-term risks?
- What other options do people with my risk of cancer or type of
cancer have?
- How do the possible risks and benefits of this trial compare
with
those options?
- What kinds of therapies, procedures and/or tests will I have
during
the trial?
- Will they hurt, and if so, for how long?
- How do the tests in the study compare with those I would have
outside of the trial?
- Will I be able to take my regular medications while in the
clinical
trial?
- Where will I have my medical care?
- Who will be in charge of my care?
- How could being in this study affect my daily life?
- Can I talk to other people in the study?
- Will I have to pay for any part of the trial such as tests or
the study
drug?
- If so, what will the charges likely be?
- What is my health insurance likely to cover?
- Who can help answer any questions from my insurance company or
health plan?
- Will there be any travel or child care costs that I need to
consider
while I am in the trial?
Also, you and your loved one should consider
utilizing some of these tips when asking your doctor about cancer
clinical trials:
- Make sure that you accompany your loved
one on their visits to the
doctor or to the research team.
- Plan what to ask ahead of time.
- Don’t hesitate to ask new questions that you may think of
while
you’re there.
- Write down questions in advance, to ensure remembering to ask
them all.
- Write down the answers, so that you and your loved one can
review them whenever needed.
- Consider bringing a tape recorder to make a taped record of
what's
said (even if you write down answers).
If your loved one does decide to
participate in a cancer clinical trial, both of you will be working
closely with the research team. Members on this team include doctors
other than and including your loved one’s specialist, nurses, social
workers, and dietitians. All of these people are there to provide
care, health monitoring and to give specific instructions about the
study. It is extremely important to follow the instructions that are
given exactly, including taking all medication which may be
prescribed during the trial. Any deviation from the protocol will
lead not only to inaccurate and erroneous information, but it could
also endanger the health and well-being of your loved one. Just
remember, with a cancer clinical trial comes hope and possibilities;
the hope of having more time with your loved one, and the incredible
possibility that a cure may be discovered from all the hard work and
dedication of both the caregiving and research teams!
For more information concerning cancer
clinical trials, contact:
The Cancer Liaison Program
Office of Special Health Issues
Food and Drug Administration
5600 Fishers Lane HF-12 Room 9-49
Rockville, MD 20857
301.827.4460
301.443.4555 (FAX)
www.fda.gov/oashi/cancer/cancer.html
E-mail: oshi@oc.fda.gov
Printable Version
