Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2019

Mixed methods to develop and evaluate a patient-reported symptom index for use with non-muscle invasive bladder cancer patients. (#77)

Claudia Rutherford 1 2 , Margaret-Ann Tait 1 , Daniel S.J. Costa 3 4 , Madeleine T King 1 , David P Smith 5 6 7 , Shomik Sengupta 8 9 , Manish Patel 10 11
  1. Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia
  2. Sydney Nursing School, Cancer Nursing Research Unit (CNRU), The University of Sydney, Sydney, NSW, Australia
  3. Pain Management Research Institute, Royal North Shore Hospital, St Leonards, NSW, Australia
  4. Sydney Medical School, Central Clinical School, University of Sydney, Sydney, NSW, Australia
  5. Cancer Research Division, Cancer Council New South Wales, Sydney, NSW, Australia
  6. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia
  7. Menzies Health Institute Queensland, Griffith University , Brisbane, Qld, Australia
  8. Australian and New Zealand Urogenital and Prostate Trials Group (ANZUP), Sydney, NSW, Australia
  9. Eastern Health Clinical School, Monash University, Melbourne, Vic, Australia
  10. Sydney Medical School, Discipline of Surgery, University of Sydney, Sydney, NSW, Australia
  11. Department of Urology, Westmead Hospital, Westmead, NSW, Australia

Aims

Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring frequent follow-up, endoscopic examinations, tumour resections, and intravesical treatments. In this clinical context, patient-reported outcomes (PROs) have enormous potential to inform treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side-effects associated with contemporary treatments. This study aimed to develop and evaluate a patient-reported NMIBC Symptom Index (NMIBC-SI) that is acceptable to patients; reliable, valid, and responsive to treatment effects; and fit-for-purpose as an endpoint in clinical trials.

 

Methods

We developed a draft 104-item NMIBC-SI through a systematic review and interviews with 26 patients and 20 clinicians, and pre-tested using cognitive interviews. We then administered the NMIBC-SI to patients on active treatment from nine Australian sites. NMIBC-SI item responses were analysed and flagged for exclusion if they had low prevalence, were conceptually similar, or highly correlated (≥0.50). Nine Urologists reviewed the results and final items for inclusion.

 

Results

Planned target accrual, n=220, was reached (178 male, mean age 69.3) representing all risk groups (Low 27.7%; Intermediate 13.2%; High 50.9%). >80% of participants did not experience 21 items, seven items were highly correlated, and four excluded as >50% of urologists rated them not directly related to NMIBC treatment (e.g. “have you had a cough?”). The final 56-item NMIBC-SI includes a 23-item symptom burden scale, two treatment-specific modules, and three optional function scales.

 

Conclusions

The NMIBC-SI allows comprehensive assessment of patients’ self-reported symptom burden and functioning impairment. A validation study commenced July 2018, recruiting newly diagnosed NMIBC patients from 15 centres across four countries. It will assess key PROs across treatments, disease trajectory (acute to 1-year survivorship), and patient risk categories. The NMIBC-SI will be suitable for use in clinical practice and future clinical trials of treatments for NMIBC.