RTOGS FIRST QUALITY-OF-LIFE STUDY - RTOG-90-20 - A PHASE-II TRIAL OF EXTERNAL-BEAM RADIATION WITH ETANIDAZOLE FOR LOCALLY ADVANCED PROSTATE-CANCER

Purpose: To assess institutional and patient compliance with quality o f life (QL) instruments in RTOG clinical trials, To assess feasibility of using the Functional Assessment Cancer Therapy (FACT), Sexual Adju stment Questionnaire (SAQ), and Changes in Urinary Function (CUF) QL i nstruments in a prostate clinical trial and to compare patient self-re port of symptoms to medical professional ratings of the same symptoms using the RTOG acute toxicity rating scales. Methods and Materials: Th ree self-assessment QL instruments, the FACT, the SAQ, and CUF, were t o be administered to patients on a Phase II locally advanced prostate trial at specified time points, Specific instructions for both data ma nagers and for patients on when, how, and why to fill out the question naires were included. Results: Sixty-seven percent (24 out of 36) of p atients accrued to RTOG 90-20 completed both the initial FACT and SAQ. Eighty-five percent completed FACT at end of RT and 73% at 3 months, Eighty-one percent completed SAQ at end of treatment, while 69% comple ted this form at 3 months. Compliance drops off thereafter, Seventy-fi ve percent of patients who had their symptom of dysuria rated by a med ical professional as 0 on the RTOG toxicity rating scale self-reported the same, Only 56% of patient self-reports on FACT regarding diarrhea were in agreement with the medical professional's RTOG rating of 0 to xicity, The measures were determined to be in moderate agreement when the patient evaluated a symptom as a 1 on the FACT and the medical pro fessional rated the same symptom as a 0 on the RTOG toxicity rating sc ale, There was moderate agreement in 13% of patients with dysuria and 31% of patients with diarrhea, Low agreement occurred when the patient evaluated a symptom as a 2 or 3 on the FACT and the medical professio nal rated the same symptom as a 0 on the RTOG scale, Low agreement occ urred in 13% of both patients reporting dysuria and diarrhea, Differen ces between how medical professionals and patients were able to rate e rectile function make direct comparisons difficult, but the trend towa rds significant discrepancies is still noteworthy. Conclusions: Qualit y of life assessments are necessary and attainable in RTOG clinical tr ials, Compliance rates for both institutional and patient participatio n were acceptable at initial and 3 month follow-up, Reasons for noncom pliance were predominantly institution related and not patient related , Strategies to address both institution and patient compliance have b een developed and implemented within the RTOG, Serious disagreement be tween patient self-reports of symptoms on the FACT QL scale and medica l professional ratings on the RTOG acute toxicity rating scales of the same symptoms was 13% at 3 months followup, This warrants continued u se of QL self-assessments in clinical trials.