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Clinical Trials in Cancer Care

 The University of Pittsburgh Cancer Institute (UPCI) prepared this information to explain to you and your family or friends what clinical trials are and how they are used to treat patients with cancer. We ask that you read this and share it with your family or friends. Visit our website for more information.

Your doctor and nurse will review this information with you and will answer any questions you may have. Your concerns are important to us; don’t hesitate to ask questions. It may be helpful to write down your questions as you think of them in the space provided at the end.

Understanding Clinical Trials

Most advances in the diagnosis, treatment, and care of patients with cancer have occurred because of research studies called “clinical trials” or “research protocols.” Clinical trials have led to improved diagnostic tests, new treatments, and slowing cancer growth. Trials also study the effect of cancer treatments such as surgery, radiation therapy, chemotherapy, and biological therapy in helping health care professionals find better ways to treat cancer.

Cancer patients and people who are at high risk for developing cancer are often asked to participate in a clinical trial. This is a very important decision to make, and it is important that patients and their families gather as much information as they need to make this decision. They should weigh the benefits and risks of clinical trials as well as practical issues such as costs involved, time commitment, travel, lodging, meals, and parking. They also should be reassured that safeguards are built into all clinical trials to protect patients’ medical and psychological health as well as their private health information.

What are Clinical Trials?

Clinical trials are studies designed to evaluate new cancer treatments. The goal of clinical trials is to find better ways to treat cancer and help cancer patients. These trials play a key role in the fight against cancer. The search for new cancer treatments or diagnostic tests often begins in the laboratory, where new drugs, agents, or procedures are tested on cells or animals. Laboratory and animal testing show that the new drugs and treatments destroy cancer cells and are safe. A clinical trial is designed to see if the new drug will destroy or modify cancer cells in human beings. A clinical trial is one of the final stages of a long and careful cancer research process.

Clinical trials may improve an existing or standard treatment for a specific cancer. The trials may test a new drug or agent, or they may help to find new and better ways to care for people with cancer as they receive treatment.

Why Take Part in a Clinical Trial?

There are several reasons why you may choose to take part in a clinical trial. There is a chance that the drug or treatment being studied will be more effective than the standard treatment for the disease. Patients seeking to play an active role in their own health may want to help scientists and health care professionals learn more about the treatment being studied, thereby helping others to benefit in the future. In the past, clinical trials were seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial.

In addition to presenting a clinical trial option, you may be asked if you would like to participate in a research registry. The research registry allows UPMC Cancer Centers to collect information about you and your disease so that we can contact you to advise you of a clinical trial opportunity or to review your medical information to see if you are eligible for a clinical trial. Any information collected will be kept confidential and stored securely.

How do Clinical Trials Work?

Clinical trials can be planned diagnostic or treatment programs or may involve observation methods that provide useful data to your doctor. Oncologists (doctors who treat patients with cancer) and oncology (cancer) nurses follow a detailed, standardized plan (protocol) for each trial. The plan helps them answer questions about the treatment or diagnostic test being studied and provides quality care for patients participating in the trial. The planning for clinical trials is based on laboratory and animal research. Agents thought to be promising are tested for effectiveness against specific disease(s) and for unknown side effects.

Before a clinical trial starts, a scientific review board evaluates each proposed clinical trial to determine whether it is scientifically sound and conducted in an appropriate manner. In addition, an institutional review board evaluates all proposals. This board is made up of health care professionals, administrators, and individuals from the community who review the trial to determine that no harm will come to patients.

Clinical trials using drugs or agents not yet licensed by the U.S. Food and Drug Administration (FDA) must receive the approval of the FDA before patients can be treated with the new drug or agent.

New cancer treatments go through three phases of testing.

  1. In Phase I trials, researchers determine the safe dose of a new drug or agent and learn about its side effects. Patients with different types of cancer may be asked to take part in a Phase I trial and are usually divided into small groups. Each group is treated with different doses of the new drug or agent so that the safest dose can be found. The highest dose of the new drug that can be given safely to people (maximum tolerated dose) also is determined.
  2. Phase II clinical trials test the effectiveness of a new drug or agent in stopping or controlling the growth of tumor cells in a certain type of cancer. Generally, these trials provide investigational treatment to a few hundred patients.
  3. The goal of Phase III clinical trials is to find which treatment — the new or the standard cancer treatment — is better. To gather information as quickly as possible, Phase III trials usually involve several hundred to thousands of patients and often are performed at the same time in cancer research centers across the country. In many Phase III studies, patients are assigned randomly to receive either the new or the standard treatment. From what is known at the time, any one of the treatments chosen could be better or of equal help to the patient. Random assignment ensures study results are not biased. When no standard treatment exists for a specific type of cancer, those receiving the new treatment may be compared to patients who do not receive treatment or who receive a placebo (a look-alike pill that has no active drugs). You will be told if this is a possibility before you agree to take part in a study.

New treatments may use new drugs or agents that are used alone or combined with other treatments. Sometimes the new treatment is a new way of using a drug already known to be useful. No matter which treatment is used, all patients taking part in a clinical trial are followed carefully by their doctor and nurse. Physical examinations, blood tests, and x-ray examinations are done before, during, and after each treatment. These examinations and tests are done to measure the effectiveness of the treatment and to help detect side effects early.

Your role in a clinical trial may change or cease for one reason or another.

  • Some clinical trials stop after a certain length of time; your doctor will determine your next course of therapy if a trial is over.
  • Your treatment may change if your disease becomes better or worse, or if side effects become severe.
  • You can stop participating in a clinical trial if at any time you or your doctor decides that the clinical trial is no longer the best treatment for you.

If your treatment in the clinical trial is stopped, you will be evaluated to see if another treatment, either a standard treatment or another clinical trial, can help you.

What About Side Effects?

Clinical trials have possible risks as well as benefits. Side effects are problems that  occur when treatment affects healthy cells.   Common side effects of standard cancer treatments 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. Side effects vary from treatment to treatment and also vary from patient to patient. Many side effects may be prevented or decreased by medication and/or other measures to make you more comfortable. Your doctor and nurse will review with you the possible risks and side effects from your treatment. They will watch for, and help you manage any side effects that occur.

Giving Consent to Participate in a Clinical Trial

Every clinical trial is designed to answer a specific research question. Each study enrolls patients with certain types and stages of cancer.  A special process is followed to see if a person is eligible to participate in a clinical trial.  This process also allows the patient time to decide if they want to participate in a clinical trial.

First, your research team will review your medical records. Your doctor will review your history and examine you. You may need to have more tests such as blood work, x-rays, or scans. The team will review the information from your medical records and test results and decide if you meet all the criteria to enter the clinical trial. If you are found not to be eligible for a trial, this does not mean that you have any particular health problems. It simply means that you do not meet all the requirements for participation in that trial.

If you meet the criteria, your doctor and research nurse will discuss with you and your family the purpose of the clinical trial and what it involves. They will explain to you and your family the treatment plan that must be carefully followed if you choose to participate in the clinical trial. They also will explain other treatments available to you.

You will receive a consent form that must be signed before you enter or start on the clinical trial. Before you sign the consent form, you will be given time to completely review the form and to discuss the consent form with your family and friends. It is important that you write down any questions that you have so that you can discuss them with your doctor or nurse before you sign the consent form.

After you have signed the consent form, you will be given a copy for your reference.

The consent form contains:

  • Information about the treatment
  • Known side effects and risks
  • Possible benefits
  • Potential costs and payments
  • Alternatives to the treatment
  • Whether you will need to be hospitalized for your treatment
  • How long the treatment will take

Participation in a clinical trial is voluntary. It is your decision. If you participate, you may decide to stop treatment at any time during the clinical trial. Your doctor and nurse will support whatever choice you make. Choosing not to take part in or withdrawing from a clinical trial will not affect your ability to receive care at UPMC Cancer Centers and University of Pittsburgh Cancer Institute. Making a decision to undergo treatment in a clinical trial takes time and careful consideration. It requires a commitment from you and your family or friends.

Other Concerns

It is not unusual to have some fears or concerns about being in a clinical trial. Many patients worry that they will become “just another research subject.” Patients in clinical trials receive the same level of care from doctors and nurses that patients not participating in clinical trials receive. Patients in clinical trials are monitored and may undergo more frequent testing and exams to help evaluate their progress. Whether or not they are participating in a clinical trial, patients regularly receive information about their condition and test results from their doctor and nurse. They learn about their disease, its treatment, and ways to help themselves.

Whether or not they are in a clinical trial, patients with cancer and their families often have mixed emotions. They may feel anger, sadness, fear of the future, or nervousness. Oncology nurses, doctors, psychologists, and social workers understand this. They can give you and your family emotional support before, during, and after the trial.

Clinical Coordinator

Patients in each clinical trial also are monitored by a research nurse who is the clinical coordinator for the trial. This nurse sees that the clinical trial tests are scheduled and completed and that the test results and any side effects are recorded. He or she can discuss all aspects of the study with you before and during treatment. The clinical coordinator works closely with your doctor and other members of yur health care team to plan your care.

Your clinical coordinator will provide you with a calendar so that you can remember when you are scheduled for treatments and tests. If you are giving yourself medications at home that are part of the clinical trial, you may be given a diary card on which to record these medications.

Confidentiality

UPMC Cancer Centers complies with all HIPAA regulations. Information that is learned about an individual participating in a clinical trial or that reflects his or her care is confidential and protected under these regulations. Study sponsors and monitors may review your medical records to ensure that clinical trial guidelines are being followed. Any information that is reported about your case will not identify you by name. Generally, only the results of the whole group of patients in the clinical trial are reported. The results of the clinical trial will be shared with health care professionals so that the findings can be used to help treat other people with cancer.

Costs

The care provided before, during, and after a clinical trial usually is billed to the patient’s health insurance plan. Laboratory and x-ray studies performed as part of routine care are billed in the same manner as are all other hospital or care-related charges. You will have to pay for services that are not covered by your insurance plan. However, any tests that are done to fulfill only the research requirements of the clinical trial are usually done without charge to you. New drugs or agents that are being tested as part of the clinical trial also may be free to you during your participation in the clinical trial. You will be told if there are any additional costs that will result from your participation in the trial.

Before you start a clinical trial, financial counselors can help you and your family understand the costs for which you will be responsible. They can help determine which costs you will need to pay and which costs are covered by your insurance. They also   can discuss methods of payment with you. If you have other concerns about your finances or your present employment, you may request a meeting with a clinical social worker.

Where is Treatment Given?

Patients enrolled in clinical trials may receive their treatment in:

  • UPMC Cancer Centers outpatient facility
  • A clinical research unit
  • A radiation oncology department in a hospital or cancer center
  • A doctor’s office
  • A combination of these locations

Care is provided by medical, surgical, and radiation oncologists and oncology nurses. Parts of some clinical trials also may be carried out by the doctor who referred you to UPCI or UPMC Cancer Centers.

For More Information

If you have additional questions that have not been addressed, please contact your oncologist or nurse. For other sources of information on clinical trials:

  • Call UPMC Cancer Centers Cancer Information and Referral Services at 412-647-2811.
  • Send an e-mail to UPMC Cancer Centers Cancer Information and Referral Services at PCI-Info@upmc.edu.
  • Visit www.AskMeAboutCancerClinicalTrials.com to hear first hand from patients about their misconceptions and concerns about clinical trials, and why they ultimately chose to participate in a clinical trial. Also hear from physicians about how trials work, the benefits and risks, and other topics. You are able to type in questions and search for clinical trials through the website.

Questions?

Your health care team wants to make certain that you have all the information you need before and during your participation in a clinical trial. Please share your questions or concerns with your doctor and nurse. Some frequently asked questions are listed below. You may use any or all of these questions as you make the decision best for you.

The study

  • What is the purpose of the study? In what phase is this research study?
  • Who sponsors the study, and who has reviewed and approved it?
  • How are the study data and patient safety being checked?
  • When and where will study results and information go?

Possible risks and benefits

  • What are the possible short- and long-term risks and side effects?
  • What are the possible benefits to me?
  • Are there standard treatments for my type of cancer?
  • How do the possible risks, side effects, and benefits in the study compare with standard treatment?

Your care

  • What kinds of treatments, medical tests, or procedures will I have during the study? Will they be painful? How do they compare with what I would receive outside the study?
  • How often and for how long will I receive the treatment, and how long will I need to remain in the study? Will there be follow-up after the study?
  • Where will my treatment take place? Will I have to be in the hospital? If so, how
    often and for how long? Can a family member stay with me during treatment?
  • How will I know if the treatment is working?
  • Will I be able to see my own doctor? Who will be in charge of my care?

Personal issues

  • How could the study affect my daily life?
  • Can you put me in touch with other people who are in this study?
  • What support is there for me and my family in the community?

Cost issues

  • Will I have to pay for any treatment, tests, or other charges?
  • What is my health insurance likely to cover?
  • Who can help answer any question from my insurance company or managed care plan?

Revised July 2011

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