Phase I study of a decision aid for patients with locally advanced non-small-cell lung cancer

Purpose: Many patients with locally advanced non-small-cell lung cancer (LA -NSCLC) are eligible for combined-modality therapy (CMT; chemotherapy and r adiotherapy). Although CMT offers slightly higher chances of survival than radiotherapy alone (RT), it also carries a higher probability of toxicity, raising the possibility that same patients may prefer to decline CMT. We re port a pilot study of a decision aid designed for patients in this setting, Patients and Methods: The aid included a structured description of the trea tment options and trade-aff exercises designed to help clarify the patient' s values for the relevant outcomes by determining the patient's survival ad vantage threshold (SAT; the increase in survival conferred by CMT over RT t hat the patient deemed necessary for choosing CMT). Additional outcome meas ures included each patient's strength of treatment preference, decisional c onflict, objective understanding of survival information, and decisional ro le preference. Results: Twenty-seven patients met the eligibility criteria for the study. Of these, seven declined the decision aid because they had a clear treatmen t preference. The remaining 20 participants completed the decision aid; 18 chose CMT, and two chose RT. All 20 patients wished to participate in the d ecision to some extent. All patients reported that using the decision suppo rt wets useful to them and recommended its use for others. No patient or ph ysician reported that the aid interfered with the physician-patient relatio nship. Patients' 3-year SATs and median SATs were each strongly correlated with their strengths of treatment preference (rho = 0.83, P < .001 and <rho > = 0.67, P = .02, respectively). For all but one patient, either their 3-y ear or median survival threshold was consistent with their final treatment choice. Ten patients reported a stronger treatment preference after using t he decision aid. Conclusion: We conclude that implementing the decision-aid for patients wit h LA-NSCLC is feasible, that it demonstrates convergent validity, and that it is favorably evaluated by patients and their physicians. The aid seems t o help patients understand the benefits and risks of treatment and to choos e the treatment that is most consistent with their values. Further evaluati on of the aid is warranted. J Clin Oncol 19:1326-1335. (C) 2001 by American Society of Clinical Oncology.