The effect of nurse-led pain education of patients with painful bone metastases on pain and quality of life: A multicenter randomized trial.

203 Background: Radiotherapy (RT) is an effective treatment for painful bone metastases, although pain is not always sufficiently controlled. Pain management education may improve patient empowerment and, consequently, reduce pain intensity. The effect of nurse-led education (NLE) in patients undergoing RT for painful bone metastases was investigated as compared to care as usual (CAU). Primary endpoint was pain intensity at 12 weeks, secondary outcome was quality of life (QoL). Methods: In this multicentre, randomised phase 3 study, patients referred for short schedule RT, with uncontrolled pain (a score of ≥5 on a 0-10 numeric rating scale (NRS)), were randomised between NLE or CAU before start of RT. The NLE consisted of a structured interview including assessment of pain knowledge, verbal and written education on all aspects of pain and follow-up phone calls at 1, 4, 8 & 12 weeks to address pain-related questions. Patients in CAU received leaflets on RT, cancer pain and opioid use. Patient characteristics were assessed at baseline. Pain intensity and QoL were evaluated with the Brief Pain Inventory, EORTC QLQ-C15-PAL and EORTC QLQ-BM22 at baseline, and week 1, 4, 8 & 12. Power calculation showed that there were 89 patients per arm needed to detect a 10% difference in number of patients with a NRS < 5 at 12 weeks(1-sided α = 0.05; β 0.8). Results: Between May 2011-April 2016, 354 patients were randomised (176 NLE, 178 CAU), 38 were excluded (30 NRS < 5 at baseline, 7 no short schedule RT, 1 missing informed consent). At twelve weeks, 185 (NLE 95) had completed follow-up (72 stopped filling out questionnaires, 59 died prematurely). Baseline characteristics were similar in both groups; mean age 65 years, 56% men. At week 12, more patients in NLE than in CAU had controlled pain (NRS < 5; respectively 66% and 52%, p = 0.036). Moreover, patients in NLE reached faster a pain score < 5 than patients in CAU (31 versus 54 days respectively, p = 0.026). On all time points, no significant differences in QoL were found between both groups. Conclusions: Controlled pain, i.e. a pain intensity < 5, was reached faster and by more patients with painful bone metastases undergoing RT by the addition of nurse-led pain education. Clinical trial information: NCT01358539.

Short Schedule Intravesical Mitomycin Preceding Transurethral Resection for Recurrent Ta-T1, G1-G2 Bladder Cancer

Aims and Background Intravesical instillations commonly follow resection, when all visible lesions have been removed, making impossible any direct assessment of efficacy. The study was conceived to evaluate the ablative effect on the tumor and the efficacy in reducing the risk of recurrence of short schedule intravesical chemotherapy administered before endoscopic resection. Study design Four weekly intravesical instillations of mitomycin C followed by transurethral resection (TUR) were administered to 31 patients with recurrent small volume superficial bladder cancer. Results At TUR no evidence of disease was found in 22 patients (70.9%) and residual disease in the remaining 9 (29.1%). At a median follow-up of 15 months (range, 3-33) 16 of 31 patients (51.6%) had recurrence of disease. The treatment was well tolerated. Conclusions Short-schedule intravesical chemotherapy can completely ablate small volume recurrent superficial bladder cancer in a relevant number of patients but is probably not sufficient to obtain long-term prophylaxis.