Symptom indexes to assess outcomes of treatment for early prostate cancer

BACKGROUND. Patients' perceptions of treatment outcomes are important in the management of early prostate cancer, but few studies have offered reliable and responsive measures to assess the likely side effects of the most common treatments. OBJECTIVE. To develop indexes of urinary, bowel, and sexual function, and related distress. RESEARCH DESIGN. Prospective cohort study of the outcomes of treatment for early prostate cancer, with self-administered questionnaires completed before treatment, and 3 and 12 months afterward. Hypothesized indexes, based on a clinical model of pathophysiological side effects of treatment, were defined and evaluated with respect to reliability and validity. SUBJECTS. Patients (n = 184) undergoing radical prostatectomy or external beam radiotherapy for early prostate cancer. MEASURES. Urinary and bowel items pertained to frequency or intensity of symptoms of dysfunction; parallel items assessed symptom-related distress. Sexual dysfunction items assessed the quality of erections, orgasm, and ejaculation; distress was assessed by 2 items adapted from the MOS Sexual Problems (MOS-SP) scale. HRQoL was assessed by the SF-36 and Profile of Mood States. RESULTS. Symptom and symptom-related distress indexes for urinary incontinence, urinary obstruction/irritation, bowel dysfunction, and sexual dysfunction were defined. Symptom and distress indexes in each domain were highly correlated. Responsiveness was substantial and varied by treatment in ways consistent with clinical experience. The indexes accounted for significant proportions of the variance in HRQoL measures. CONCLUSIONS. These indexes may be used in monitoring outcomes of treatment for early prostate cancer.