The iBLAD app protocol – a national, exploratory study on a multimodality smartphone app in bladder cancer for better understanding symptoms, quality of life and need for supportive care

References

• Rhea LP, Mendez-Marti S, Kim D, et al. Role of immunotherapy in bladder cancer. Cancer Treat Res Commun. 2021;26:100296.
   PubMedGoogle Scholar
• Yu EY, Petrylak DP, O'Donnell PH, et al. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):872–882.
   PubMed Web of Science ®Google Scholar
• Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939–949.
   PubMed Web of Science ®Google Scholar
• EORTC Quality of Life. 2021. https://qol.eortc.org/quality-of-life/
   Google Scholar
• Bitting RL, Healy P, George DJ, et al. Phase II trial of enzalutamide and androgen deprivation therapy with salvage radiation in men with high-risk prostate-specific antigen recurrent prostate cancer: the STREAM trial. Eur Urol Oncol. 2021;4(6):948–954.
   PubMed Web of Science ®Google Scholar
• McGregor B, O'Donnell PH, Balar A, et al. Health-related quality of life of patients with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin after platinum and PD-1/PD-L1 inhibitor therapy: results from cohort 1 of the phase 2 EV-201 clinical trial. Eur Urol. 2022;81(5):515–522.
   PubMed Web of Science ®Google Scholar
• Taarnhøj GA, Johansen C, Pappot H. Quality of life in bladder cancer patients receiving medical oncological treatment; a systematic review of the literature. Health Qual Life Outcomes. 2019;17(1):20.
   PubMedGoogle Scholar
• Catto JWF, Downing A, Mason S, et al. Quality of life After bladder cancer: a cross-sectional survey of patient-reported outcomes. Eur Urol. 2021;79(5):621–632.
   PubMed Web of Science ®Google Scholar
• Smith AB, McCabe S, Deal AM, et al. Quality of life and health state utilities in bladder cancer. Bladder Cancer. 2022;8:55–70.
   Web of Science ®Google Scholar
• Di Maio M, Basch E, Bryce J, et al. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016;13(5):319–325.
   PubMed Web of Science ®Google Scholar
• Beaver CC, Magnan MA. Managing chemotherapy side effects: achieving reliable and equitable outcomes. Clin J Oncol Nurs. 2016;20(6):589–591.
   PubMed Web of Science ®Google Scholar
• Coolbrandt A, Van den Heede K, Vanhove E, et al. Immediate versus delayed self-reporting of symptoms and side effects during chemotherapy: does timing matter? Eur J Oncol Nurs. 2011;15(2):130–136.
   PubMed Web of Science ®Google Scholar
• Basch E, Deal AM, Kris MG, et al. Symptom monitoring With Patient-Reported outcomes During routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34(6):557–565.
   PubMed Web of Science ®Google Scholar
• Di Maio M, Basch E, Denis F, et al. The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO clinical practice guideline. Ann Oncol. 2022;33(9):878–892.
   PubMed Web of Science ®Google Scholar
• Taarnhøj GA, Johansen C, Carus A, et al. 1556MO The iBLAD study: patient-reported outcomes in bladder cancer during oncological treatment: a multicenter national randomized controlled trial. Ann Oncol. 2022;33: s 1259–S1260.
   Google Scholar
• Taarnhøj GA, Lindberg H, Dohn LH, et al. Electronic reporting of patient-reported outcomes in a fragile and comorbid population during cancer therapy - a feasibility study. Health Qual Life Outcomes. 2020;18(1):225.
   PubMed Web of Science ®Google Scholar
• Tolstrup LK, Bastholt L, Dieperink KB, et al. The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial. J Patient Rep Outcomes. 2020;4(1):88.
   PubMedGoogle Scholar
• Basch E, Schrag D, Henson S, et al. Effect of electronic symptom monitoring on Patient-Reported outcomes Among patients With metastatic cancer: a randomized clinical trial. JAMA. 2022;327(24):2413–2422.
   PubMed Web of Science ®Google Scholar
• Tolstrup LK, Pappot H, Bastholt L, et al. Patient-Reported outcomes During immunotherapy for metastatic melanoma: mixed methods study of patients’ and clinicians’ experiences. J Med Internet Res. 2020;22(4):e14896–e14896.
   PubMed Web of Science ®Google Scholar
• Taarnhøj GA, Johansen C, Lindberg H, et al. Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease. Cancer Med. 2020;9(9):3078–3087.
   PubMed Web of Science ®Google Scholar
• Calvert M, King M, Mercieca-Bebber R, et al. SPIRIT-PRO extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open. 2021;11(6):e045105.
   PubMed Web of Science ®Google Scholar
• Taarnhøj GA, Lindberg H, Johansen C, et al. Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy. J Patient Rep Outcomes. 2019;3(1):56.
   PubMedGoogle Scholar
• National Cancer Institute. Patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). 2019. https://healthcaredelivery.cancer.gov/pro-ctcae/
   Google Scholar
• Mendoza TR, Dueck AC, Bennett AV, et al. Evaluation of different recall periods for the US national cancer institute’s PRO-CTCAE. Clin Trials. 2017;14(3):255–263.
   PubMed Web of Science ®Google Scholar
• Tolstrup LK, Pappot H, Zangger G, et al. Danish translation, cultural adaption and initial psychometric evaluation of the patient feedback form. Health Qual Life Outcomes. 2018;16(1):77.
   PubMed Web of Science ®Google Scholar