A great deal is riding on good clinical trials.
For researchers, it is the only means by which new therapy and procedures can be evaluated for potential benefits and harms in humans. For patients, it can be an opportunity to play an active role in your health care; to potentially receive cutting edge treatments before they are widely available, and to get the best health care available.
In a nutshell, clinical trials may offer new hope.
It’s clear clinical trials have brought enormous advances in the areas of prevention, treatment and diagnosis for the whole of society, but experts say a number of barriers still exist.
The National Cancer Institute, part of the Institutes of Health estimate less than 5 percent of adults diagnosed with cancer each year will get treated through enrollment in a clinical trial.
“With broader enrollment, the effort to find new and better ways to treat and prevent cancer might be swifter,” says Ezekiel J. Emanuel, M.D., Ph.D., chair of the Department of Clinical Bioethics at the National Institutes of Health.
So why are so few people participating?
One reason may simply be fear. Another culprit is likely ignorance.
A survey by Harris Interactive, Inc., in 2000, suggests eight out of 10 cancer patients were unaware that clinical trials could be an option for them. Of those, 75 percent said they would have been willing to enroll had they known it was possible.
A 2007 study published by Journal of the National Comprehensive Cancer Network, found psychosocial barriers exist for patients that may impact participation in clinical trials.
The study asked 170 patients, and 137 oncologists to consider seven potential barriers to clinical trials. Both groups highly ranked random assignment and fear of receiving a placebo, but patients identified fear of side effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as least important to their patients.
“Cancer combined with its treatment is viewed as an event that evokes distress and emotional anguish taxing the individual's ability to cope” according to a 2002 French literature review. “Many participants may fear, for the purpose of research, that they may be assigned to less than optimal therapy or that their care will be carried out in a sterile scientific atmosphere devoid of humane and personal consideration. These and other reasons may cause unacceptable personal distress that overrides the potential therapeutic gain.”
The French study suggests a cancer diagnosis coupled with the rigors of clinical trial participation can have significant psychological implications for patients. Stress, and anxiety can “trigger the onset of a mood disorder or exacerbate a present symptom.”
Dr. William Robiner Ph.D., A.B.P.P., L.P, is a Professor and Director of Health Psychology at the University of Minnesota Medical School studies the psychological aspects of medical and neurological illnesses, and the psychological effects of clinical trial participation. In the early to mid-1980s during the height of the HIV/AIDS epidemic, Robiner examined the psychological effects of participation and non-participation in AIDS treatment clinical trials. The paper was published in the Journal of Acquired Immune Deficiency Syndromes.
Relatively little attention in contemporary medicine has been paid to the possibility that psychological distress may result in clinical research, he says. Most studies are concentrating on how to improve the patient’s health outcomes.
“It’s natural for some patients to feel distress at the onset of the study,” Robiner said. “But as the trial progresses, much of that distress is alleviated by the benefits of participation. The benefits typically outweigh the risks. For most people, participation is a rational choice. They feel less stress knowing at least they are doing something, as opposed to nothing. That can be powerful.”
Robiner says patients thinking of clinical trial participation should only enter a trial if they are highly motivated to do so. That means fully understanding what the trial is, what is expected of you as the patient, understanding the risks and benefits of participation, and staying realistic to what outcomes are expected.
Caretakers should be included in the informed consent discussion. This will help to avoid miscommunication and undue stress during the process and will likely to create a cohesive team with the study staff to get the best possible outcome.
“If you enter a trial, you must be willing to accept whatever the treatment is, and staying with it long enough to see if it works,” he said.
Anne Coscarelli, PhD., a clinical psychologist and Director the Simms/Mann-UCLA Center for Integrative Oncology at the Jonsson Comprehensive Cancer Center in Los Angeles says while any medical treatment has associated benefits and risk, there are things people can do to help alleviate fear and anxiety:
- Ask questions. Talk with the study doctor and understand what kind of study you will be participating in; what are the goals of the study and how they will likely affect you. “The research nurse can also be really helpful in understanding the risks and benefits during the Informed consent process. For many people, information is a powerful stress reducer,” Coscarelli said.
- Identify your motives for participation. Understanding your own hopes and expectations of study participation— remission, improved function, or preservation in this moment in time—is an important component, but so is identifying your contribution to fellow patients. “Many people who participate in clinical trials aren’t just interested in living a life, they are interested in living a meaningful life,” said Coscarelli. “Many patients understand they have a personal investment in the trial, by they are also contributing something meaningful to science. This can help bring solace and more meaning to their life.”
- Be Realistic. Recognizing any treatment has associated risks and benefits can be helpful to curbing anxiety when dealing with a new or unknown treatment, Coscarelli said. Look at your options and decide what's best for you. A person might say ‘If I choose option A (the clinical trial) I could be getting the next best gold standard in treatment, but even if I choose B (the current standard treatment), there are risks associated with that too.’
- Learn to Manage Stress. Any illness can be a stress producer. By learning positive coping strategies, you can bring down the fear and anxiety you may be experiencing. For instance, prepare a set of positive reinforcing statements to tell yourself when you feel anxious. Coscarelli said that how we talk to ourselves everyday either helps us feel better and move forward or can provoke fear and anxiousness. Another technique is practicing complementary medicine techniques — conscious breathing, progressive muscle relaxation, mindfulness, and guide imagery — to help us overcome stress and anxiousness.
- Identify your social network. Face it, not everyone in your social network helps you feel relaxed. By identifying those who do and calling on them when you feel stressed or anxious can be very powerful, Coscarelli said.
Lynette Summerill is an award-winning writer and Scuba enthusiast living in San Diego, CA with her husband and two beach loving dogs. In addition to writing about cancer-related issues for EmpowHER, her work has been seen in newspapers and magazines around the world.
Sources and patient information:
Basic Questions and Answers about Clinical Trials. Food and Drug Administration. Accessed online 15 March 2012 at: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm121345.htm
Interview: Dr. William Robiner. 14 March 2012.
Psychological Effects of Participation and Nonparticipation in a Placebo-Controlled Zidovudine Clinical Trial with Asymptomatic Human Immunodeficiency Virus-Infected Individuals. Robiner, W.N. et al. 1993. Journal of Acquired Immune Deficiency Syndromes; 6:795- 805. http://www.ncbi.nlm.nih.gov/pubmed/8509981
Interview: Dr. Anne Coscarelli. 19 March 2012.
Participate in Clinical Trials. National Institutes of Health.Accessed online 15 March 2012 at: http://www.cc.nih.gov/participate.shtml
Barriers to clinical trial participation as perceived by oncologists and patients.
J Natl Compr Canc Netw. 2007 Sep ;5(8):655-64. Accessed online at: http://www.ncbi.nlm.nih.gov/pubmed/17927923
Psychological distress of cancer and clinical trial participation: a review of the literature.Eur J Cancer Care (Engl). 2002 Mar;11(1):6-15. Kelly C, Chazi F. Caldwell K. Abstract online at: http://www.ncbi.nlm.nih.gov/pubmed/11966830
Doctors, Patients Face Different Barriers to Clinical Trial. National Cancer Institute. Accessed online: http://www.cancer.gov/clinicaltrials/researchabout/developments/doctors-barriers0401
Reviewed March 20, 2012
by Michele Blacksberg RN
Edited by Jody Smith