Impact of quality of life on patient expectations regarding phase I clinical trials

Purpose: Quality of life (QOL) is increasingly recognized as ct critical ca ncer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and researc h nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patien t perceptions regarding treatment options. Methods: Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires tha t assessed demographics, QOL, and treatment expectations. Results: Compared with their physicians, patients overestimated potential b enefits and toxicities from experimental therapy (mean expected benefit, 59 .8% v 23.8%, P < .01; mean expected toxicity, 29.8% v 16.0%, P < .01). Pati ents estimated a greater potential for benefit (59.8% v 36.8%, P < .01) and less potential for toxicity (29.8% v 45.6%, P = .01) for experimental ther apy, compared with standard therapy. Short Form-36 general health perceptio n correlated with patient perception of potential benefit from experimental therapy (r = .48, P = .01), Conclusion: Participants in phase I clinical trial have high expectations r egarding the success of experimental therapy and discount potential toxicit y, Patient QOL may affect the expectation of benefit from experimental ther apy and, ultimately, treatment choice. Understanding the interactions betwe en QOL and patient expectations may guide the development of improved strat egies to present appropriate information to patients considering early-phas e clinical trials. (C) 2000 by American Society of Clinical Oncology.