If you are an older patient, you may think clinical studies, also called clinical trials, are not for you simply because of your age. But this is not necessarily the case. Older people have different levels of health and independence and different expectations of treatment. In many cases a person’s age need not be a major factor in determining their treatment options for cancer or another serious disease.
Historically, older patients have been underrepresented in clinical studies. But the trend is improving.
Decisions about treatment are personal. No matter what your age, if you have cancer or another serious disease, you should consider all available treatment options, including clinical studies. Ask your Fred Hutch treatment team about the risks, benefits, and goals of each treatment option to decide which is best for you.
Worldwide, the population of older adults is increasing. Since the greatest risk factor for cancer is age, it is no surprise that the majority of new cancer cases and cancer-related deaths are in people over age 65. This is also why experts predict the number of older cancer patients and survivors seeking treatment will increase exponentially in the future.
Studies of many different cancers have demonstrated that age may be a factor in the tendency for cancer to spread, and older patients may need to take different dosages of medications and may experience different side effects than younger patients. Since the course of cancer and the effects of treatment may be different in older people, studies that involve older people with cancer are needed to find the best interventions for this growing population.
Other factors that tend to decrease the number of older patients in studies include preference for treatment from their community doctor (who is less likely to offer studies), difficulty getting to health care centers where studies take place, additional time required for enrollment and follow-up, and costs of care.
Certainly studies in older populations are complicated by these factors, but with modifications more clinical studies could be appropriate for older adults. For example, studies could evaluate outcomes that are more relevant to older adults, such as how their quality of life is affected (like how long they go without symptoms or how toxic the treatment is for them), instead of how long it takes for their disease to progress.
Even though older patients have been underrepresented in clinical studies in the past, this is starting to change. In the United States, the increase may be due to expanding Medicare coverage for studies. In addition, as reported by the American Society of Clinical Oncology in 2013, three-fourths of patients over 70 said they would be willing to take part in a study, so perhaps more patients and their doctors are considering studies as an option.
Despite this need, few older people participate in clinical studies. As recently as the mid-1990s, less than one in four clinical study participants was 65 years old or older; yet this same age group made up almost two-thirds of new cancer diagnoses and nearly three-quarters of cancer-related deaths.
There are many reasons why more older adults don’t participate in clinical studies, including:
Whatever your age, consider clinical studies. Ask your doctor whether you qualify for any studies and whether any of them might be a good option for you. For more information, be sure to read the rest of this patient guide to clinical studies. Also, there are several other websites where you can learn more, including websites specific to older adults.
Luckily, cancer in children is rare — less than 1 percent of cancers diagnosed in the United States are in children. Of course, that is probably little consolation if you are a parent or family member of a youngster with this disease.
The relatively low rate of pediatric cancer makes it especially important for doctors and scientists nationwide to work together on research studies that gather data from different treatment centers so they can learn more, more quickly, about how to get the best results for patients. Nearly all children diagnosed with cancer in this country are cared for at one of more than 200 institutions that make up Children’s Oncology Group (COG). Seattle Children’s is one of them.
Through cooperative efforts such as COG, doctors continue to make significant progress in treatment. Clinical studies, also called clinical trials, are the backbone of this success. In fact, more than half of all American children with cancer receive their therapy as part of a clinical study.
As a result of the progress made through research, the outlook for most children with cancer is promising—about 80 percent of children diagnosed today survive. This is a significant improvement compared to the 10 to 20 percent survival rate seen 50 years ago.
If your child has been diagnosed with cancer, his or her doctor may talk to you about having your child participate in a clinical study. Participation is completely voluntary. Whether your child participates in a clinical study or not, through Seattle Children’s and Fred Hutch your child will get the same high quality of care.
When considering a clinical study, you will likely want to understand any differences between the standard treatment for your child’s disease and the treatment your child would receive in the study. In a typical randomized clinical study for children with cancer, some children receive the standard treatment, while others receive an investigational treatment. Often this investigational treatment is very similar to the standard; for example, it may be the same drug given at a different dose or given with a different combination of drugs previously shown to be effective. Your child’s treatment team can explain all your child’s treatment options, including standard and investigational treatments.
Ask as many questions of your child’s treatment team as you need to feel comfortable before deciding on a study. Talk with your child’s treatment team about how much time you have to decide on a course of treatment. Depending on your child’s disease, doctors may need to start treatment very quickly, or you may have days or weeks to make a treatment choice.
Doctors understand that you may want a second opinion before deciding, and they will not be offended if you ask about getting one. The ideal way to do this is to discuss it with your child’s primary oncologist to ensure that any consulting doctor has timely access to your child’s full medical information.
Since cancer in children is uncommon, most cancer therapies have not been tested in children. A common approach has been to use data from adult research and adjust for the body weight of the child; however, children aren’t just small adults.
Differences between adults and children in the biology of tumors, metabolism, organ development, and body proportion may cause children to respond differently to treatments. This is one reason why it’s important to conduct studies with children as well as adults. It’s also important that researchers working with children give special consideration to the differences. Even so, it may be comforting to know that in many clinical studies of an intervention not previously used in children, the treatment has already been tested in adults.
Another important difference is that children under the legal age of consent — age 18 — cannot give informed consent, which implies fully understanding the study process, the risks, and other factors. This means you must be involved in the decision and must give permission for your child to enroll in a study.
Depending on your child’s age, he or she may be able to understand at least some aspects of this decision and may have an opinion. According to the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, children age 7 or older can assent or dissent (agree or not agree) to take part in studies. According to the National Cancer Institute, researchers must obtain a child’s assent unless:
Before your child assents or dissents, the study must be explained to them in terms appropriate to their age. Your child’s treatment team can help with this. Visual aids may help, too.