To Trial or Not to Trial: That Is the Question
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
 

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