“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.