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How to Find a Cancer Treatment Trial: A 10-Step Guide
    Posted: 03/21/2005


Before You Start:
Steps 1-3

Step 1

Step 2

Step 3

Searching for a Trial:
Steps 4-6

Step 4

Step 5

Step 6

After Finding a Trial:
Steps 7-10

Step 7

Step 8

Step 9

Step 10

Diagnosis Checklist

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After Finding a Trial: Step 8

Ask Questions About the Trial

Whether you or someone from your health care team calls the clinical trial coordinator, this is the time to get answers to questions that will help you decide whether or not to join this particular clinical trial.

It will be helpful if you can talk about your diagnosis in a manner that is brief and to the point. Before you make the call, rehearse with a family member or friend how you will present the key details of your diagnosis (Diagnosis Checklist). This will make you more comfortable when you are talking with the clinical trial coordinator and will enable you to answer his or her questions smoothly.

TIP: Download the PDF version of this guide and save it to your own computer. Then you can print it out and fill in the answers to these questions to keep for later use.

Questions To Ask the Trial Coordinator

1. Is the trial still open?
On occasion, clinical trial listings will be out-of-date and will include trials that have actually closed to further enrollment.

2. Am I eligible for this trial?
The trial coordinator will ask you many, if not all, of the questions listed on your Diagnosis Checklist (Step 3). This is the time to confirm that you are indeed a candidate for this trial, although a final decision will likely await your first appointment with the clinical trial team (Step 10).

3. Why do researchers think the new treatment might be effective?
Results from earlier clinical trials will highlight the potential effectiveness of the treatment you may receive. The strength of the earlier evidence may influence your decision. You or someone who knows how to read the medical literature may also want to use a Web-based service such as PubMed to explore any previously published evidence related to the trial you're interested in.

4. What are the risks and benefits associated with the treatments I may receive?
Every treatment has risks. Be sure you understand what risks and side-effects are associated with any of the treatments you might receive as a participant in this trial. Likewise, ask for a detailed description of how the treatments may benefit you.

5. Who will monitor my care and safety?
Primary responsibility for the care and safety of patients in a cancer clinical trial rests with the clinical trial health care team. In addition, clinical trials are governed by safety and ethical regulations set by the federal government and the institution or organization sponsoring and carrying out the trial, including a group called the Institutional Review Board (IRB). The trial coordinator will be able to give you more information. You can also see Protecting Participants in Clinical Trials.

6. May I get a copy of the protocol document?
In some cases, the trial coordinator may be allowed to release the full, detailed protocol document to you. However, the protocol summary and the informed consent document will probably answer most of your questions about the trial's design and intention.

7. May I get a copy of the informed consent document?
The U.S. Food and Drug Administration requires that potential participants receive complete information about the study. This process is known as “informed consent” and must be in writing. It may be helpful to see a copy of this document before you decide whether or not to join the trial. For more information about informed consent, see A Guide to Understanding Informed Consent.

8. Is there a chance I will receive a placebo?
Placebos are rarely used in cancer treatment trials, but be sure you understand what possible treatments you may or may not receive for any trial you are thinking of joining.

9. Is the trial randomized?
In a randomized clinical trial, participants are assigned, by chance, to separate groups or “arms.” Each arm receives a different treatment, and the results are compared. In a randomized trial, you may or may not receive the new treatment. See What Is Randomization?

10. What is the treatment dose and schedule in each arm of the trial?
You will want to consider this when you are discussing your various treatment options with your health care team. Does the dose seem reasonable? Is the treatment schedule manageable for you?

11. What costs will I be responsible for?
In many cases, the research costs are paid by the group sponsoring the trial. Research costs include the treatments under study and any test performed purely for research purposes. However, you or your insurance plan would be responsible for paying “routine patient care costs.” These are the costs of medical care (e.g., doctor visits, hospital stays, x-rays) that you would receive whether or not you were in a clinical trial. Some insurance plans don't cover these costs once you join a trial. Consult your health plan, if you have one, or go to States That Require Health Plans to Cover Patient Care Costs in Clinical Trials to see if your plan must provide such coverage. You may also wish to refer to Clinical Trials and Insurance Coverage - A Resource Guide.

12. If I have to travel, who will pay for travel and lodging?
Some trials may pay for your travel and lodging expenses. Otherwise, you will be responsible for these costs.

13. Will participation in this trial require more time than if I had elected to receive standard care? Will participation require a hospital stay?
Understanding how much time is involved may influence your decision and help you make plans.

14. How will participating in the clinical trial affect my everyday life?
A cancer diagnosis can be very disrupting to the routine of everyday life. Many patients seek to keep those routines intact as they deal with their diagnosis and treatment. This information will be useful in evaluating any additional help you may need at home.

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