The following are some questions to ask the research team when thinking about a clinical trial. Write down any questions you might have and bring your list with you when you first meet with the research team.
What treatment or tests will I have? Will they hurt?
What are the chances I will get the experimental treatment?
What are the possible risks, side effects, and benefits of the study treatment compared to my current treatment?
How will I know if the treatment is working?
How will you protect my health while I am in the study?
What happens if my health problem gets worse during the study?
How will the study affect my everyday life?
How long will the clinical trial last?
Where will the study take place? Will I have to stay in the hospital?
Will you provide a way for me to get to the study site if I need it?
Will being in the study cost me anything? If so, will I be reimbursed? Will my insurance cover my costs?
Can I take my regular medicines while in the trial?
Who will be in charge of my care while I am in the study? Will I be able to see my own doctor?
Will you follow up on my health after the end of the study?
Will you tell me the results of the study?
Whom do I call if I have more questions?
How will you keep my doctor informed about my participation in the trial?
Does the study compare standard and experimental treatments?
If I withdraw, will this affect my normal care?
What are the chances that I will receive a placebo?
A promising new study from Mayo Clinic, in conjunction with Caris Life Sciences, points to immunotherapy as a possible treatment option for patients with the difficult-to-treat triple negative breast cancer mutation. The study was presented this week at the 50th annual meeting of the American Society of Clinical Oncology in Chicago.
“This study may change our ability to treat triple negative breast cancer patients,” says Barbara Pockaj, M.D., lead investigator of the study and Mayo Clinic surgeon. “We may have signs that these patients can be treated with immunotherapy. We don’t have a lot of options for these patients and this would really expand our options.”
The new treatment may not work or it may not be better than the standard treatment.
You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.
How Will My Safety Be Protected?
This is a very important question. The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research. Research abuses like the Tuskegee Syphilis Experiment, which began in 1932, before safeguards were in place, will NOT happen again.
Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed.
An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors, scientists, and lay people, like yourself, who are dedicated to making sure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants are as low as possible.
Along with the IRB, many clinical trials are closely supervised by a Data and Safety Monitoring Committee. The Committee is made up of experts in your condition who periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away.
The informed consent process also helps protect participants. Before joining a clinical trial, you will be told what to expect as a participant and all the things that might happen. For example, someone from the research team will explain possible side effects or other risks of the treatment. As part of the informed consent process, you will have a chance to ask questions about the trial. The clinical trial coordinator will be happy to answer your questions.
After getting all this information, you can think about whether or not you want to participate. If you decide to join the trial, you will be given an informed consent form to sign. By signing the form, you show that you have been told all the details and want to be part of the study. The informed consent form is NOT a contract. You can leave the trial at any time and for any reason without being judged or put in a difficult position regarding your medical care. Researchers must keep health and personal information private.
Hair in your ears and nose is a good thing. It keeps junk in the air from getting in your body. It can start getting a little crazy as we get older, though – and no one knows why exactly. If you’re tempted to trim that unruly nose and ear hair, here are some of the best tips on how to go about it.
Kenneth Mack, M.D., Ph.D., a Mayo Clinic pediatric neurologist, describes symptoms, diagnosis and treatment options for chronic daily headaches in children. For more information, see http://www.mayoclinic.org/migraine/children.html.
Each year, millions of Americans face the reality of living with a mental health condition. However, mental illness affects everyone directly or indirectly through family, friends or coworkers. It has impacted our family and, more than likely, yours. Despite the reach and prevalence of mental illnesses, stigma and misunderstanding are also, unfortunately, widespread.
That is why each year, during the first full week of October, the National Alliance on Mental Illness (NAMI) and participants across the country raise awareness of mental illness. Since this week was set aside by Congress in 1990, efforts to educate the public, fight stigma and provide support have grown stronger.
It is important to discuss mental health illnesses year-round, but highlighting them during Mental Illness Awareness Week provides a dedicated time for mental health advocates across the country to come together as one unified voice. Advocates are working together to sponsor activities, large or small, to educate the public about mental illness.
What Is Mental Health?
Mental health refers to your emotional and psychological well-being. Having good mental health helps you lead a relatively happy and healthy life. It helps you demonstrate resilience and the ability to cope in the face of life’s adversities.
Your mental health can be influenced by a variety of factors, including life events or even your genetics.
There are many strategies that can help you establish and keep good mental health. These can include:
keeping a positive attitude
staying physically active
helping other people
getting enough sleep
eating a healthy diet
asking for professional help with your mental health if you need it
socializing with people whom you enjoy spending time with
forming and using effective coping skills to deal with your problems
What is Mental Illness?
A mental illness is a broad term which encompasses a wide variety of conditions which affect the way you feel and think. It can also affect your ability to get through day-to-day life. Mental illnesses can be influenced by numerous factors, including:
It helps the doctor—and you—if he or she knows about the non-medical parts of your life. Where you live, how you get around, and what activities are important to you—these are all things that can make a difference in decisions about your health care. The following are some examples of practical matters you might want to discuss with your doctor. For additional information and resources on these topics, see the resources at the end of this article.
Planning for Care in the Event of a Serious Illness
You may have some concerns or wishes about your care if you become seriously ill. If you have questions about what choices you have, ask your doctor. You can specify your desires through documents called advance directives, such as a living will or healthcare proxy. One way to bring up the subject is to say: “I’m worried about what would happen in the hospital if I were very sick and not likely to get better. Can you tell me what generally happens in that case?”
In general, the best time to talk with your doctor about these issues is while you are still relatively healthy. Medicare and private health insurance may cover these discussions with your doctor. If you are admitted to the hospital or a nursing home, a nurse or other staff member may ask if you have any advance directives.
Driving is an important part of everyday life for many people, and making the decision to stop driving can be very difficult. Tell your doctor if you or people close to you are concerned about your driving and why. He or she can go over your medical conditions and medications to see if there are treatable problems that may be contributing to driving difficulties.
Another hard decision that many older people face is whether or not to move to a place where they can have more help—often an assisted living facility. If you are considering such a move, your doctor can help you weigh the pros and cons based on your health and other circumstances. He or she may be able to refer you to a social worker or a local agency that can help in finding an assisted living facility.
Don’t hesitate to ask the doctor about the cost of your medications. If they are too expensive for you, the doctor may be able to suggest less expensive alternatives. You can ask if there is a generic or other less expensive choice. You could say, for instance: “It turns out that this medicine is too expensive for me. Is there another one or a generic drug that would cost less?”
Osteoarthritis causes pain in your joints and can make it hard to move. Although OA can be painful, you can get relief with a number of treatments from pain relievers to surgery. Find what these treatments are and how they work.