The concept of a clinical trial is not new to the world of medicine. Patients who meet the specific qualifications for the trial either receive treatment as part of an experimental group or a placebo as part of a control group. For researchers, trials have two outcomes from this point on: the treatment works and passes on to further rounds of testing, or it fails and new approaches must be considered. However, from the perspective of those participating in the trial, months or years of testing, treatment, and stress must be endured before either of these conclusions can be reached, resulting in a process that can be both physically and emotionally exhausting. While the psychological effects of these experimental treatments are extensively researched and doggedly followed during the trial’s duration, less research has been conducted regarding the effects of clinical trial participation on the patient’s psychological health.
A National Cancer Institute (NCI) study from 2009 sought to answer this question . Although the study was terminated in 2013 and the NCI did not publish any findings, its format provides the basis for many smaller undertakings of a similar nature. Between 2009 and 2010, the NCI enrolled 200 people suffering from eleven different types of metastatic cancer in its trial and categorized them based on which type of treatment they were receiving. Some of the patients were participating in the randomized trials commonly associated with the phrase clinical trials, either receiving treatment or a placebo. Others received standard, off-trial treatment in which they were aware that they were definitely receiving chemotherapy or targeted therapy – the use of drugs or similar substances to specifically target cancer cells – for their cancer . Had the study not been terminated, these patients would have taken psychological questionnaires in order to assess their levels of depression. It was the hope of the NCI that comparison of these questionnaires would reveal trends in the psychological states of patients participating in clinical trials and would allow trial organizers to meet the needs of their patients more effectively.
The NCI’s study would have been the most prominent research connected to the psychological effects of clinical trial participation and the only one to have sought a direct answer to the questions it poses. Although the link between cancer trial participation and depression or anxiety rates has not yet been defined, the association between cancer diagnosis and psychiatric morbidity has long been acknowledged by physicians . Patients who display symptoms of psychiatric morbidity suffer from both physical and psychiatric decline as a result of their psychiatric condition. Often in patients who suffer from cancer, these psychiatric conditions are anxiety and depression regarding their diagnosis or prognosis. According to a University of Sussex study, if left untreated, the persistence of major depression can increase the rate of physical deterioration and lead to hastened spread of cancer symptoms. This trend in psychological morbidity is not isolated to patients who participate in randomized trials or those who receive standard treatment off trial, but can affect any patient who develops depression following cancer diagnosis.
Because psychiatric morbidity can have such detrimental effects to the physical aspects of cancer treatment, it is of utmost importance to ensure the psychological health of patients. In a study conducted by the Tom Baker Cancer Centre of the University of Calgary, ninety patients of varying diagnoses and prognoses participated in a series of mindfulness exercises over the course of their outpatient treatment . These exercises covered a wide array of methods used in support groups and counseling sessions, from group discussions and yoga to the introduction of metacognitive techniques and breathing exercises. Over the course of seven weeks, participants completed assessments which evaluated mood and stress levels. Across the entire study, participants who actively worked toward the mindfulness goals put forth in the exercises demonstrated significant decreases in stress and mood disturbances. The results of the study were not combined with any information regarding the effectiveness of the patients’ cancer treatment; however, in combination with the proven effects of increased stress and depression levels on psychiatric morbidity, it can be reasonably assumed that the effect of increasing mindfulness approaches in cancer cannot be detrimental to the mental and physical health of the participating patients.
With the termination of the NCI study and no replacement study currently being performed, it cannot be concluded that patients participating in clinical trials for cancer treatment suffer from depression or similar mental illnesses at a higher or lower ratio than patients receiving standard treatment. However, even under the assumption that clinical trial patients suffer from these disorders at approximately the same proportion as patients receiving other types of treatment, the trend toward psychiatric morbidity and the potential for psychologically-influenced physical deterioration is reason enough to consider implementing changes to future clinical trials similar to those conducted in the outpatient program. By decreasing stress and mood disturbance, not only could physicians improve the psychological health of their patients, they could also decrease potential interferences of psychiatric morbidity in the outcome of their trials.
- “Psychological and Emotional Impact in Patients Undergoing Treatment for Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy.” National Institute of Health. 8 May 2009.
- “Targeted Cancer Therapy.” American Cancer Society.
- Fallowfield, L. et. al., “Psychiatric morbidity and its recognition by doctors in patients with cancer.” British Journal of Cancer. 84:8. 2001. 1011-1015.
- Speca, Michael, et. al. “A Randomized, Wait-Listed Controlled Clinical Trial: The Effect of a Mindfulness Meditation-Based Reduction Program on Mood and Symptoms of Stress in Cancer Outpatients.” Psychosomatic Medicine. 62:5. 2002. 613-622.
- Thomson Reuters. Cortellis Clinical Trials Intelligence. http://lifesciences.thomsonreuters.com/cortellis-clinical-trials-intelligence
Courtney Jirsa is a Biology/Biological Anthropology major at The George Washington University. She is interested in the many ramifications of cancer on the human experience, from genetic connections to psychological repercussions.