If you have been diagnosed with cancer, you may desire a second opinion before making treatment decisions. Whether the second opinion confirms the same diagnosis or brings up new factors to consider, it can help you rest in knowing you are making informed decisions.
Because second opinions are considered a patient’s right, many insurance plans cover a second opinion. Check with your insurance plan to see if it covers a second opinion.
Your oncologist at the Kirkland Cancer Center will carefully consider all aspects of your case and will give you and your family his or her best recommendations for your treatment. If you then desire a second opinion about either the diagnosis or treatment recommendations, we will help guide you to the most appropriate center and will assist you in making appointments.
Studies for New Cancer Medication and Treatments
A clinical trial at the Kirkland Cancer Center is a research study or clinical study to evaluate a new medication or treatment for cancer. Clinical trial studies are the best way to determine new therapies for helping people be healthier or prevent diseases such as cancer. Today’s standard cancer treatments were developed through clinical trials.
Before a clinical trial can be released to the public, it is carefully studied in a laboratory. This research helps determine which methods will most likely be successful and to their best knowledge, safe and effective. Clinical trials undergo a rigorous approval process by the Food and Drug Administration (FDA). Although there is always a possibility that a new treatment will be disappointing, the researchers and physicians who approve a study have reason to believe that it will be as good as, or better than, current treatments.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are the benefits and risks?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
Play an active role in their own health care.Gain access to new research treatments before they are widely available. Obtain expert medical care at leading health care facilities during the trial.Help others by contributing to medical research.
There are risks to clinical trials. There may be unpleasant, serious or even life-threatening side effects to experimental treatment. The experimental treatment may not be effective for the participant. The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
Plan ahead and write down possible questions to ask.Ask a friend or relative to come along for support and to hear the responses to the questions.Bring a tape recorder to record the discussion to replay later.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Talk to your Medical or Radiation Oncologist for more information about clinical trials.
Your provider or navigator will discuss with you and determine your need and explain the role of genetic testing:
- Assessing if inheritance played a role in the development of an individual’s cancer or a family member’s cancer
- Providing patient education and answering questions about the option of genetic testing, and the risks and benefits of genetic testing
- Obtaining genetic samples to send to appropriate testing sites
- Reviewing medical management, screening and surveillance options with or without genetic testing
- Discussing insurance coverage of testing, and confidentiality concerns regarding who might see genetic test results and how they might be used
- Communicating results and implications of results with you
- Information about appropriate research programs and/or clinical trials
Risk Factors for Hereditary Cancer
About 5-10% of all cancer is due to a change in someone’s inherited genetic makeup, or DNA. Cancer genetic counseling is the process of helping people understand and adapt to the medical, psychological and familial implications of inherited predisposition to cancer. This process integrates cancer risk assessment, education and counseling. Some red flags for hereditary cancer include:
- A family history of multiple cases of the same or related types of cancer
- One or more relatives with rare cancer
- Cancer occurring at an earlier age of onset than usual (for instance, under age 50)
- Bilateral cancer
- Multiple primary cancers
Contacting a Genetic Counselor
Patients may be referred to a Genetic Counselor through primary care providers, surgeons, medical oncologists, and their staff, social workers, case managers, or other members of the health care team. If you have any questions about genetic counseling or would like to make an appointment, please discuss with your provider to assist with a referral.
The Tumor Registry is an important part of the cancer program. The registry is a collection of data of patients diagnosed and/or treated with cancer. The data includes patient demographics, extent of disease, treatment and lifetime follow-up. It is staffed by two full-time certified registrars who are trained in current cancer care methods, information collection, and statistical evaluation. The registrars are members of the National Cancer Registrars Association.
Since our 2004 reference date, the registrars have accessioned over 21,000 cases with approximately 1700 new cases diagnosed/treated in 2017. A follow-up rate of 90 percent is consistently maintained with a physician or patient follow-up letter.
Quality assurance is performed by a physician audit on at least 10% of yearly cases. This assures accuracy in staging in addition to establishing a link between the medical staff and registry.
Registry data may be used to:
- Monitor patient outcomes
- Provide current patient follow-up and disease status
- Determine community screenings and early detection programs
- Evaluate referral patterns
- Calculate patient survival
- Plan administrative and educational programs
Registry data is submitted to:
- Tennessee Cancer Registry
- Facility Information Profile System (FIPS)
- National Cancer Data Base (NCDB)
- American Cancer Society
Researchers use these systems to determine cancer trends and treatment patterns, patient outcomes, educational and community screening guidelines.
NONDISCRIMINATION NOTICE STATEMENT
West Tennessee Healthcare (WTH) does not exclude, deny benefits to, or otherwise discriminate against any person on the grounds of race, color, national origin, age, religion, disability, Limited English Proficiency or sex, including discrimination based on gender identity, sexual orientation, sex stereotyping or pregnancy in admission to, participation in, or receipt of the services and benefits under any of its programs and activities, whether carried out by WTH directly or through a contractor or any other entity with which WTH arranges to carry out its programs and activities.
For further information about this policy, contact Amy Garner (731) 541-9914.