Need for Improved Physician-Patient Communication About Phase I Trials

Patients and physicians differsignificantly in their perceptions of phase I clinical trial outcomes andthe content of treatment discussions, according to a multicenter study presentedat the 38th annual meeting of the American Society of Clinical Oncology. Phase Istudies typically evaluate new drugs or drug combinations that have not yet beentested in humans, and are offered to patients for whom a standard treatmentoption does not exist.

"We conducted this study because we need to betterunderstand the decision-making process of this vulnerable group of cancerpatients," said Neal J. Meropol, MD, a medical oncologist at Fox ChaseCancer Center in Philadelphia and principal investigator for the study.

Study Data

A total of 328 cancer patients were surveyed after havingmade a decision about whether to participate in a phase I trial. Of these 328patients, 79% elected to enroll in a phase I trial. The physicians of 246 ofthese patients (75%) also completed the survey.

Patients were asked about perceived life expectancy withtreatment as well as the potential for benefit and toxicity associated withstandard and experimental approaches; 71% thought they would survive more than 2years with experimental therapy, whereas only 15% of their physicians predictedthat patients would survive more than 2 years. When asked to estimatepotential for benefit and harm under different treatment conditions (0%-100%),patients predicted a greater likelihood of benefit and toxicity than did theirphysicians. These findings applied to both experimental and standard treatmentoptions.

"These results raise the possibility that patients donot clearly recognize the likely outcomes from therapy," said Dr. Meropol."In addition, they may reflect a component of hope and optimism."

Although 95% of surveyed patients stated that quality of lifewas at least as important as length of life, only 34% reported that"changes in quality of life with treatment" were discussed with theirphysician. In contrast, 79% of the surveyed physicians reported that this issuewas discussed.

Conclusions

"Taken together, these findings suggest thatpatient-provider communication in this context may be suboptimal," said Dr.Meropol. "In an effort to improve treatment decision-making and theinformed consent process, we are conducting a follow-up study in which aWeb-based communication aid is used to identify the information preferences andvalues of cancer patients. The results of the survey are shared with patients’physicians before their consultation in an effort to alert physicians to thespecific needs of individual patients."

The study was funded by a grant from the National Cancer Institute.