1556MO - The iBLAD study: Patient-reported outcomes in bladder cancer during oncological treatment: A multicenter national randomized controlled trial

Background

Patient-reported outcomes (PROs) are widely used, but little is known of the impact of applying PROs in specific cancer diagnoses. We report the results of a randomized controlled trial (RCT) of PROs in patients with muscle-invasive or metastatic bladder cancer (BC) undergoing medical oncological treatment (MOT) with focus of determining the effects of using PROs during chemo- or immunotherapy.

Methods

This multicenter RCT recruited patients at four Danish university hospitals from 2019–2021. Inclusion criteria were: BC stages T2-T4NxMx, initiating chemo- or immunotherapy. Patients were randomized 1:1 between answering selected PRO-CTCAE questions from home electronically once weekly (QW) with a built-in alert-algorithm as a supplement to standard procedure for handling of side effects (intervention arm (IA)) vs standard procedure for handling of side effects (control arm (CA)). Depending on the severity of PRO-CTCAE symptoms in the IA, patients were instructed how to handle a given side effect (either self-handling or contact to oncological nurse or physician). Patient responses in the intervention arm were available for the treating physicians, who were requested to review these at each clinical visit. The co-primary clinical endpoints were hospital admissions and rate of treatment completion. Secondary endpoints were overall survival (OS), quality of life (EORTC’s QLQ-C30 and QLQ-BLM30), dose reductions, PRO-CTCAE scoring.

Results

228 patients with bladder cancer were included, 76% were male. 141 (62 %) of the patients had metastatic disease at study entry, evenly dispersed between the two groups. 49 % of patients in the IA did not complete treatment vs. 44 % of patients in the CA, OR 0.83 (95% CI: 0.48-1.44, p=0.51). 41 % of patients in the IA experienced hospitalization vs. 32 % in the CA, OR 1.48 (95% CI: 0.83-2.65, p=0.17). OS was comparable between the two arms (IA: median 22.3mo (95% CI: 17.0-NR) vs. CA: median 23.1mo (95% CI: 17.7-NR). Questionnaire completion rate was high (73-87%), as was physician viewing of completed questionnaires in the intervention arm (94%).

Conclusions

This RCT did not show an effect on completion of treatment, hospitalization, or overall survival of the active use of PROs for BC patients during MOT, despite a high level of patient and physician compliance.

Clinical trial identification

NCT03584659.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Danish Cancer Society, Dagmar Marshalls Fond, Einar Willumsens Mindelegat, A.P. Møller Lægefonden, Christian Larsen og Dommer Ellen Larsens Legat, Rigshospitalets Fond til støtte for onkologisk formål, Onkologisk Forskningsfond and Rigshopitalets Jubilæumsfond.

Disclosure

All authors have declared no conflicts of interest.