So you have received the news no one wants to hear: a diagnosis of cancer. This can leave you with many choices to make and a lot of information to process. One of your most important decisions is finding an oncologist and establishing a relationship with this specialist. The next step will be discussing treatment options, side effects of those options, and length of treatment. Running through your mind may be questions such as: How will I get to treatment? Will I still be able to work? Will I lose my hair? Will I be able to take care of myself? How will I pay for all of this? All these questions can be overwhelming, but they are perfectly normal.
One option that can be considered during the decision process is participating in a clinical trial. What are clinical trials? The National Institutes of Health has described clinical trials as interventions that test new treatments, new combinations of drugs, or new approaches to procedures, including surgery or radiation therapy. All clinical trials involve people. Some clinical trials test screening, diagnosis, and behavior, which will be described below. However, the term clinical trial is commonly used to describe a treatment trial of new drugs or drug combinations.
Oncology trials test new treatments or a combination of treatments. Some trials may include a control group to compare the study drug’s effectiveness against the current standard of care. It is unknown if the study drug will be more effective than the standard of care treatment, so being randomized to the standard of care group may not necessarily mean assignment to an inferior treatment group. Remember, taking part in a clinical trial is voluntary, and you are allowed to end your participation at any time.
There are numerous factors to consider when deciding whether to participate in a clinical trial, so let’s explore them in detail.
Timing: Clinical trials are not always a last resort; they may be recommended early in your treatment journey. Participating in a trial at an earlier stage could provide access to innovative treatments not yet approved for your specific cancer. In addition, trial enrollment may be time sensitive, as participating cancer centers may have a limited number of patients that they are able to enroll.
Location: The location of the trial site may be significant. Trials are often conducted at academic hospitals, and not all hospitals offer the same trials. Traveling away from home may not be feasible for you because of jobs, family obligations, and cost of travel.
Cost: All trials cover the cost of the drug and tests that are performed because of clinical trial requirements. However, medical tests that would be considered standard of care for treating your cancer will be billed to your insurance. Additional costs that should be considered may include travel, parking, gas, and overnight stays for monitoring your response. These additional costs may restrict your ability to participate. These are all things that should be thought of ahead of time and should be included in the written consent form.
Risk: With any drug treatment, whether proven or in a clinical trial, there are risks. It is important to become aware of the risks/side effects of a drug. All clinical trial participants receive close monitoring for side effects, including adverse events. Specific guidance for managing these side effects is incorporated into the trial protocol so measures can be taken promptly. These measures may require the doctor to reduce the drug dosage, give the patient a treatment break to recover from the side effects, or remove a patient from the trial. Again, as a trial patient, you have the right to request to be taken off the trial for any reason at any time.
Benefits: You can be among the first people to get the next cutting-edge treatment not yet available to the general public. Being part of a clinical trial also allows you to be more focused on your treatment. You will have another set of eyes looking in on you and another phone number to call if and when you have questions. The clinical researchers are members of your team and are more people who will be cheering you over the treatment finish line. Contributing to the advancement of science to improve treatment for those who come after you also brings a sense of pride and accomplishment that can lift your spirits at a time when you can use it.
What if you decide that a treatment trial does not seem to be the route you want to go? You may want to consider other types of clinical trials that may be appropriate for you.
Screening trials test new ways for detecting diseases or health conditions. Low-dose computed tomography (also known as a CT scan) for lung cancer was once the focus of a screening trial.
Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition. For example, some ask for a piece of the cancer tumor either from biopsy or surgery and/or a blood sample. These trials are looking for a different way to detect cancers or a new targeted therapy. Targeted therapies use the mutations of your cancer to attack the tumors or stop it from growing.
Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health. For example, trials that help people quit smoking or use exercise to treat pain address behavioral issues.
Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with health conditions or illnesses. These can even be part of a clinical trial in which you participate. Examples are trials about the financial toxicity of cancer treatment, or the best way to start a palliative care program. There is even a clinical trial on why people in rural communities do not participate in clinical trials.
When considering clinical trial participation there is another important thing to consider—this is a legacy. What do you want your legacy to be? The tissue that you leave for scientists to test could be a piece that leads to the treatment that ends cancer or to a better way of detecting it. The trial that you participate in could be the treatment that ends cancer as a battle but establishes it as a chronic condition, like diabetes or coronary heart disease, that we learn to live with for a very long time.
Ultimately, the decision to participate in a clinical trial is personal and voluntary. It should be made only after careful consideration of all the factors involved and reading the consent material. You may want to discuss your options with your family or trusted friends. It is essential to discuss your options with your healthcare provider and ask any questions you may have before making a decision.
Sources
- National Institutes of Health. The basics. www.nih.gov/health-information/nih-clinical-research-trials-you/basics
- United States Food and Drug Administration. Clinical research versus medical treatment. www.fda.gov/patients/clinical-trials-what-patients-need-know/clinical-research-versus-medical-treatment
About the Author
Gayla Hall, RN, is a clinical trial coordinator and a former caregiver.
