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 radiotherapy). 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 report a pilot study of a decision aid designed for patients in this setting, Patients and Methods: The aid included a structured description of the treatment options and trade-aff exercises designed to help clarify the patient's values for the relevant outcomes by determining the patient's survival advantage threshold (SAT; the increase in survival conferred by CMT over RT that the patient deemed necessary for choosing CMT). Additional outcome measures included each patient's strength of treatment preference, decisional conflict, objective understanding of survival information, and decisional role preference. Results: Twenty-seven patients met the eligibility criteria for the study. Of these, seven declined the decision aid because they had a clear treatment preference. The remaining 20 participants completed the decision aid; 18 chose CMT, and two chose RT. All 20 patients wished to participate in the decision to some extent. All patients reported that using the decision support wets useful to them and recommended its use for others. No patient or physician reported that the aid interfered with the physician-patient relationship. 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-year or median survival threshold was consistent with their final treatment choice. Ten patients reported a stronger treatment preference after using the decision aid. Conclusion: We conclude that implementing the decision-aid for patients with LA-NSCLC is feasible, that it demonstrates convergent validity, and that it is favorably evaluated by patients and their physicians. The aid seems to help patients understand the benefits and risks of treatment and to choose the treatment that is most consistent with their values. Further evaluation of the aid is warranted. J Clin Oncol 19:1326-1335. (C) 2001 by American Society of Clinical Oncology.