Research

Deciding to participate

Treatment for cancer or another serious disease can involve a number of unpleasant moments—needle sticks, scans, the placement of ports and tubes, and the biggies like surgery and chemotherapy. So why would a person receiving treatment volunteer to take part in research on top of everything else?

There are many reasons for participating in a clinical study, also called a clinical trial. Ultimately the decision to take part in research belongs to you, the patient. The decision you make will probably be a result of a combination of diverse reasons—some large, some small, some based on scientific evidence, some based on personal attitudes and feelings about health and disease.

Some people participate in clinical trials because there are no standard treatments available for them or because the treatment they already tried didn’t work.

Others participate for altruistic reasons, such as wanting to advance medical knowledge. For example, according to Julie R. Gralow, MD, director of Breast Medical Oncology at Seattle Cancer Care Alliance (SCCA), “Some women with breast cancer sign up for clinical trials so that if and when their daughters or granddaughters are dealing with it 20 years from now, there will be better treatments.” Whatever your reasons, a clinical trial may be an option for you.

Pros and cons of clinical trials

As with any treatment option, clinical trials have a number of pros and cons you may want to consider when deciding whether to participate.

Some reasons to participate in a clinical trial include:

  • You may gain access to new interventions that are not available otherwise—and if the new intervention proves to be better than standard care, you may be among the first to benefit from it.
  • If you are in a Phase III randomized study (meaning you’re randomly assigned to a treatment group) and you don’t receive the new treatment being studied, you will receive the standard treatment for your disease.
  • You may get closer monitoring. This is a plus for many people who have fears and concerns that can be allayed by frequent checkups and conversations with doctors and nurses.
  • You may help other people who have the same condition as you by advancing scientific knowledge of the disease and its treatment.
  • By considering all of your treatment options, including clinical trials , you are taking an active role in an important decision that affects your life.

Clinical trials are not right for everybody. Some reasons you may decide not to participate are:

  • In terms of effectiveness and side effects, new treatments being studied are not always better than, or even as good as, standard care.
  • You may fear the unknown and the potential loss of choice from being in a study. For example, if you are in a randomized study, you will not get to choose which arm of the study you’re in; you will be randomly assigned to an arm. If the study is blinded, you will not know which treatment (investigational or standard) you are receiving. In early clinical studies, the safety, side effects, and effectiveness of the treatment are still being ascertained.
  • You may not have the time. Being in a study may require more time—for example, because there may be more tests or scans to monitor your response—than getting standard treatment.
  • Your health insurance plan may not cover all of the costs associated with a clinical trial.
Finding the right clinical trial

Your Seattle Cancer Care Alliance (SCCA) doctor has detailed knowledge about studies that may be available for people with your type and stage of cancer or other illness, and he or she is uniquely qualified to assess the potential of a new treatment for your condition.

If you are willing to participate in a clinical study, your doctor will help you determine if there are studies you may be eligible for and which one, if any, is the best choice for you. For some rare kinds of cancer, there are very few clinical studies available. For other types of cancer, you may have several studies to choose from.

Use our list of questions to ask about clinical studies to gather details on each study you’re considering. If you are eligible for a large number of studies, you may want to enlist a friend or family member to help you collect and sift through the information.

Second opinions

Ask as many questions of your treatment team as you need to feel comfortable before deciding to participate in a study. Talk with them about how much time you have to decide on a course of treatment. Depending on your 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 primary oncologist to ensure that any consulting doctor has timely access to your full medical information.

Finding the right clinical trial

Your Seattle Cancer Care Alliance (SCCA) doctor has detailed knowledge about studies that may be available for people with your type and stage of cancer or other illness, and he or she is uniquely qualified to assess the potential of a new treatment for your condition.

Researching clinical trials

Decisions about treatment for cancer or another serious disease, including whether or not to participate in a study, can be overwhelming. The Internet makes searching for clinical studies easy and fast.

If you are considering participating in a study and want to know more, there are many websites that can help you. But the volume of search results can be daunting, information about studies is sometimes highly technical, and some websites leave out vital details.

Cautions when researching studies online

As you review clinical studies on the Internet, ask yourself these questions:

  • Does the website indicate whether the study is Phase I, Phase II, Phase III, or Phase IV? The study phase gives you an idea of how far along a treatment is in the clinical study process and which questions the researchers are trying to answer with the study.
  • Does the website disclose the risks of participating in the study? If not, ask for this information or do more digging so you can consider the risks before making a decision about whether to participate.
  • Does the website’s list of benefits of participation include financial factors like free parking or payment for taking part in the study, rather than focusing on the medical benefits to patients? While financial incentives might be nice, be sure to weigh all the risks and benefits of participating.
  • If the website asks you to provide any personal information, does the site spell out its privacy policy for protecting this information? With any website, be mindful about what you share and how it might be used.

Be cautious about information you find online, and if you have questions be sure to talk with your Seattle Cancer Care Alliance (SCCA) treatment team. They can help you make an informed decision about whether a particular study is right for you.

Helpful websites

These links can help you find general information about clinical research as well as specific clinical studies.

American Cancer Society (ACS)
www.cancer.org
ACS, a nationwide community-based voluntary health organization dedicated to eliminating cancer as a major health problem, has a wealth of information about all kinds of cancers. In addition, ACS is the largest nongovernmental source of funds for cancer research in the United States. Learn more about ACS’s commitment to research.

ClinicalTrials.gov
www.clinicaltrials.gov
ClinicalTrials.gov, a service of the U.S. National Institutes of Health (NIH), is a registry and results database of publicly and privately supported clinical studies conducted around the world. It provides general information about clinical studies and allows users to find studies.

National Cancer Institute (NCI)
www.cancer.gov
NCI is part of NIH and is the U.S. government’s principal agency for cancer research and training. NCI conducts and supports programs in research, training, and education in the cause, diagnosis, prevention, and treatment of cancer, as well as the ongoing care of people with cancer and their families. The clinical trials section of NCI’s website includes a list of more than 12,000 ongoing clinical studies, general information about clinical studies, and results summaries of recently completed clinical studies, among other information.

NCI’s Cancer Information Service is a free, confidential service that can give you information about clinical studies, including helping you search for clinical studies that may be appropriate for you. To contact the service:

  • Call (800) 4-CANCER (800-422-6237), Monday through Friday, 5 a.m. to 5 p.m.
  • Chat online at LiveHelp, Monday through Friday, 5 a.m. to 8 p.m.
  • Email anytime using the NCI contact form.

Office for Human Research Protections (OHRP)
www.hhs.gov/ohrp
This site may be helpful if you want to understand more about what goes on behind the scenes to safeguard people who take part in studies. OHRP provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

U.S. Food and Drug Administration (FDA)
www.fda.gov
FDA is responsible for protecting the public health by regulating foods, drugs, vaccines, biologics, blood products, medical devices, electronic products, cosmetics, veterinary products, and tobacco products. FDA is also responsible for advancing public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

Websites specific to children

Children’s Oncology Group (COG)
www.childrensoncologygroup.org
With more than 8,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe, COG is the world’s largest organization devoted exclusively to childhood cancer research. More than 90 percent of children diagnosed with cancer in the United States are cared for at COG member institutions. COG’s website has a section about research. You can also find information on diagnosis, treatment, coping with cancer, and follow-up care for children with cancer and their families.

CureSearch for Children’s Cancer
www.curesearch.org
CureSearch is a national nonprofit foundation that funds children’s cancer research and clinical studies and provides education and resources for children with cancer and their families and friends. You can find information about research studies, as well as children’s cancers, tests, procedures, treatments, emotional support, and more on the CureSearch website.

Websites specific to older adults

National Institute on Aging (NIA)
www.nia.nih.gov
NIA, which is part of NIH, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The institute’s information on clinical trials and older people might be of interest if you’re considering participating in a study.

NIHSeniorHealth
www.nihseniorhealth.gov
This website, developed for older adults by NIA and the National Library of Medicine, features up-to-date aging-related health information that is easy to access and easy to understand. Visit the section about participating in clinical trials.

Researching clinical trials

Decisions about treatment for cancer or another serious disease, including whether or not to participate in a study, can be overwhelming. The Internet makes searching for clinical studies easy and fast.

Questions to ask about clinical trials

You can use the following questions to gather and keep track of information about clinical studies you are eligible for and may be considering as a treatment option. Print this page to use as a worksheet.

Study name

Record the name of the study and any details that will help you distinguish the study from others you may be considering.

Study details

Record details of the study, including answers to the following questions:

  • What is the purpose of this study?
  • What type of study is this?
  • What is the phase of this study?
  • What tests and treatments does the study involve?
  • How is the treatment in the study different from standard treatment for my disease
  • How long will the study last?
  • What is known about the new intervention being studied? What results—efficacy and side effects—have been reported?
  • What are the benefits and risks associated with participating in this study?
  • What are the alternatives to participating in this study?
  • Who will monitor my care and safety during the study?
  • Will my health insurance plan pay for treatment I receive in this study? Are there additional costs to me associated with this study? What financial resources besides insurance are available to me to help pay?
  • What are the logistics of participating? Do I live close to the clinic where the study is taking place, or am I willing and able to travel to participate in it? What kinds of support will be available to me and my family if I participate?
  • After getting a chance to read the informed consent documents, do I understand the study and do I feel comfortable participating?

Discuss any questions with your Seattle Cancer Care Alliance treatment team as well as family and friends to ensure you have as much information as you need to make the right decision for yourself.

Questions to ask about clinical trials

You can use the following questions to gather and keep track of information about clinical studies you are eligible for and may be considering as a treatment option. Print this page to use as a worksheet.

Myths vs. Facts About Clinical Studies

You’ve probably heard various things about clinical studies—some true, some false—that may impact your decision about whether to participate. Here are some myths and facts to consider.

MYTH: Clinical studies are not safe. I’d be gambling with my health if I signed up.

FACT: Many measures are in place to protect the safety of people who take part in studies—from careful study design to oversight by institutional review boards and periodic monitoring of study data by independent experts. Clinical study participants receive regular and careful medical attention and are closely observed for safety concerns. During the study, researchers must inform you of any new risks, benefits, or side effects they discover. By taking part in a Phase III clinical study, you have the chance to try a new treatment that is generally not available outside of a clinical study. If the treatment is better than standard therapy, as a clinical study participant you may be among the first to benefit from it. Read more about participant safety and clinical study phases.

MYTH: I should agree to take part in a clinical study only if my cancer is terminal or there are no other treatment options available outside a study.

FACT: Some clinical studies are reserved for cancer patients who have exhausted all the treatment options for their disease, but studies are open to patients in other situations too. There are clinical studies that look at methods to prevent cancer in people at high risk. Some studies focus on ways to detect and diagnose cancer. Other studies focus on preventing recurrence in patients whose cancer is in remission. And other studies focus on treatment of patients with advanced cancer or on the quality of life of cancer patients and survivors. Read more about the various types of clinical studies.

MYTH: My health insurance won’t pay for treatment provided through a clinical study.

FACT: Many people don’t even consider a clinical study because they are afraid that their health insurance company will not cover the treatment. In fact, your health insurance may pay for treatment. The majority of patients in clinical studies do receive at least some reimbursement from their health insurance, but health insurance may not pay all the costs. Most often, the study itself will pay for the study therapy and insurance companies will pay for the routine care procedures. You can ask Seattle Cancer Care Alliance (SCCA) staff and your insurance company in advance for help determining which costs are likely to be covered. Read more about health insurance and clinical studies.

MYTH: In a clinical study cancer patients may be given therapy known to be ineffective.

FACT: Placebos, which do not contain any known active ingredient, are used in research to control for the placebo effect—the expectation that an intervention will work. A placebo may not be used in a study as a comparison or control if it would mean putting people at risk by denying them effective therapy. This is particularly true for serious illnesses, such as cancer, where placebos are rarely used. A placebo may be used in a study to test drugs that might prevent cancer, but the people enrolled in such a study would not have cancer. If a placebo is used by itself in another type of cancer study, it is used because no standard treatment exists. In this case, the study would compare the effects of a new treatment with the effects of a placebo. More often studies compare a standard treatment plus a placebo with the same standard treatment plus an investigational treatment. You can find out in advance if a study you are considering might involve a placebo.

MYTH: I will receive poorer or better medical treatment in a clinical study.

FACT: Whether you decide to participate in a clinical study or not, through SCCA you will receive the same high quality of care from some of the world’s leading cancer specialists. People in clinical studies are monitored very closely, which can be reassuring. In Phase III clinical studies, participants receive either the standard treatment or an investigational treatment that researchers have reason to believe is better than the standard treatment. In a randomized study (nearly all Phase III studies) researchers cannot guarantee which treatment you will receive, and they cannot guarantee outcomes. If one treatment arm in a study is proven to be significantly more effective during the course of the study, the participants may all be moved to that arm of the study.

MYTH: If I join a clinical study, I won’t be able to drop out without jeopardizing the quality of my treatment.

FACT: You may quit a clinical study for any reason at any time. The quality of care you receive through SCCA will not be affected by your decision to participate in or withdraw from a study. If you decide to withdraw, your medical team may ask to continue monitoring you for a period of time to assess any long-term effects of the treatment you received in the study.

MYTH: Researchers do not want to enroll older cancer patients.

FACT: Older patients are underrepresented in clinical studies but not because researchers don’t want to sign them up. People age 65 or older make up 54 percent of people with new cancer diagnoses but only about one-third of adult participants (people age 30 or older) in cancer clinical studies. It’s important to test interventions in a wide variety of people because they can work differently in people of different ages, races, ethnicities, and genders; older patients are welcome in many studies. Learn more about older patients and clinical studies.

Myths vs. Facts About Clinical Studies

You’ve probably heard various things about clinical studies—some true, some false—that may impact your decision about whether to participate. Here are some myths and facts to consider.