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Clinical trial FAQs, the experience of participating in a clinical trial at FWMOH

Being prompted with the option to participate in a clinical trial may be overwhelming. Shelley Seabolt, RN, MSN, FNP-C, discussed some of the most commonly asked questions regarding clinical trials.

Barbara B. shares her experience as a patient at Fort Wayne Medical Oncology and Hematology, participating in a clinical trial.

,,What is a clinical trial?

“Clinical trials study the safety and effectiveness of new treatments. A clinical trial is an option for a patient to receive treatment that is not available as part of standard of care. It is a new drug, generally with a standard of care option. There are some clinical trials that study drug versus placebo, as well. It is an option for a patient that they would not generally have outside of the standard of care.”

What is the importance of clinical trials?

“The importance of clinical trials is for the development of new drugs to provide new options for patients when they are diagnosed with a cancer.”

What are some of the benefits and risks with a clinical trial?

“Some benefits to participating in a clinical trial is the opportunity to take part in a new and innovative treatment option that may help your cancer diagnosis. Many times, study drugs are provided, however; that is study dependent.”

“Some of the risks are not knowing whether you are going to benefit from participating in a clinical trial. The ultimate goal is for us to develop new treatment options for patients when they are diagnosed with cancer.”

What happens if a patient receives a placebo?

                “A placebo is a medication that is given that has no effect on your cancer. Many studies that involve placebo are blinded and we do not know whether you are receiving the real medication or placebo. Only a small fraction of cancer clinical trials use placebo. If a placebo is part of the trial you are considering, you will be fully informed of that ahead of time. You would only be considered for such a trial when it is safe or medically appropriate.”

Who can participate in a clinical trial?

“There are many different clinical trials for many different disease statuses. Each trial has its own inclusion and exclusion criteria. If there is a clinical trial available for the diagnosis that the patient has, then we look to see if that patient would be a candidate based on the stage of their disease and their past medical history. Some studies exclude patients with certain past medical history diagnoses.”

 

How do you join a clinical trial?

“To join a clinical trial, the patient is notified by their primary oncologist and offered the clinical trial. The consent is discussed with what the study is and what drugs are involved. The patient is then given the opportunity to take part in the clinical trial. They are not required to, it is just another option that Fort Wayne Medical Oncology and Hematology can offer those patients.”

Shelley Seabolt joined Fort Wayne Medical Oncology and Hematology in 2013 after serving as a registered nurse at Lutheran Hospital for 2 years. She earned her Master’s Degree in nursing from Indiana Wesleyan in 2018. Shelley also is the manager of research at Fort Wayne Medical Oncology and Hematology.

Barbara B. shares her story, as follows.

How has your life changed as a result of being a part of FWMOH?

“When I was first diagnosed with cancer it was a shock because I had no symptoms of lung cancer, so I didn’t really know what to think or feel. When I went to FWMOH, I saw Dr. Nalamolu and she said she would be there to see me through, and she has been. After I went on the study, Dr. Babu was as well. They have always been there for me, very positive, and very supportive. In the beginning, I felt like there was not a whole lot of hope. But, they always encouraged me and that was important. I went from thinking ‘How long until I die?’ to an attitude of ‘How many more years can I live?’”

How has your perception of clinical trials changed?

                “In the beginning I had the idea that clinical trials were all a blind study, where you didn’t really know if you were going to get the drug or not. As I learned more about how it would be done [at FWMOH], I was relieved to learn that everybody got the drug. You didn’t have to worry about not getting the drug. Another thing I learned was that there would be a lot more reporting than I thought there would be. Once I got into it, all the health issues in my life were reported back, all of my blood work that got reported back, I even have books I fill out and that got reported back. I was surprised to find out how much information actually got back [about the clinical trial at Fort Wayne Medical Oncology and Hematology] about what was going on with me.”

What most stood out to you about FWMOH?

                “Over the fourteen years that I have been going [to FWMOH], I have seen a lot of change. I have seen that they are willing to change the environment and protocols to better serve their patients. They’re all a caring team that treats you as an individual, not just a patient. The infusion nurses are fantastic. From the minute you go into one of their pods, you feel like you’re going to be taken care of while you’re there in a vulnerable situation.”

What would you tell your past self prior to embarking on this journey?

                “Have hope, be positive, don’t be afraid to ask questions and be a little bit more assertive about letting people know what your needs and thoughts are.”

   

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