The iBlad App - a National, Exploratory Study on a Multimodality Smartphone App in Bladder Cancer for Better Understanding of Symptoms, Quality of Life and Need for Supportive Care

Design The iBLAD app study is an investigator-initiated, national, Danish multicenter, exploratory trial connected to the group of bladder cancer responsible specialists at the six Danish treatment centers. The study is carried out in accordance with the SPIRIT-PRO Protocol Guidance.

Study plan The app is developed by the app provider Journl who is specialized in ePRO apps. The app is in Danish. The patient will be able to download the app and create a user profile when a clinician has registered the patient in Journl's system as a bladder cancer patient in oncological treatment. After giving informed consent, the patient will (be helped to) download the app on their private smartphone. The patient will answer the first questionnaires in relation to the first treatment. The first patient is expected to be enrolled in December 2022. Patients can use the app as long as treatment is ongoing. Patients can at any time withdraw their consent and stop using the app. The patient will receive daily notifications from the app if there is an unanswered questionnaire to minimize missing data.

Questionnaires In the app, Bladder cancer patients will receive an electronic questionnaire weekly with selected questions from the PRO-CTCAE library. The questions have been carefully selected for their specific disease and condition. The epo-CTCAE questionnaire consists of 15 symptoms comprising of 30 questions on symptoms and side effects. Each symptom is elicited using between one to three questions on frequency, severity, and interference with daily activities. Weekly reporting was chosen as this is the preferred recall period for PRO-CTCAE questionnaires. Depending on the patients´ response and due to predefined thresholds, the patient will get feedback for supportive care or be advised to contact the hospital. Moreover, the patients will be asked to complete EORTC QLQ-C30 and EORTC QLQ-BLM30 monthly to monitor their QoL (see supplementary material). All electronic questionnaires will be completed at home. An expert group, consisting of nurses and clinicians, has selected the questionnaires as the most relevant questionnaires for this patient population.

Patient feedback and inclusion in the clinical encounter The questionnaires are the same regardless of the patient's oncological treatment but is developed to cover both chemotherapy and ICI. The patients receive immediate feedback in the app as they complete the symptom questionnaire. The advice given can continuously be found in the app. The advice is based on an algorithm linked to the severity of the symptoms or side effects that the patient reports. The algorithm including type of intervention was developed by the expert group. The symptom and QoL scores are also sent to the hospital where the clinician can access the patient reporting and are trained and prompted to review the scores at patient visits. Thus, the patient reporting not only serves as a reflection of the patient's condition to be used for research purposes but can also be used as a dialogue tool during the clinical encounter. Accordingly, the app will enable regular symptom tracking, feedback to patients and QoL reporting to achieve earlier symptom management and improved supportive care. The ePRO questionnaires are added to standard of care and the symptoms highlighted will be treated in alignment with standard procedures. In routine care, clinicians carry out toxicity registration prior to each cycle of anti-neoplastic treatment, typically every three or four weeks. The weekly patient reporting in the app takes place at home in between visits to the hospital. Alert algorithms and thresholds for alerts can be seen in Supplementary material.

Patient videos In addition to completing questionnaires in the app, the patients will also gain access to a variety of short videos with former bladder patients recruited from the Danish bladder cancer organization. The subjects of the videos were decided on during a workshop carried out with six bladder cancer patients who had all received anti-neoplastic treatment. Thus, the participants in the workshop took part in deciding what the app should contain in terms of informative and relevant video material on the experiences of bladder cancer patients. Fifty-three videos will be produced with five bladder cancer patients (three men and two women). In the videos, the patients share peer-to-peer insights on how they experience being bladder cancer patients, covering a wide range of topics such as living with cancer, operation, treatment, sexual issues, family relations, rehabilitation and quality of life.