Bladder Cancer, Urothelial Carcinoma
Conditions
Keywords
Patient-reported outcomes, Electronic reporting of symptoms, Immunotherapy, Chemotherapy
Brief summary
Electronic reporting of patient-reported outcomes with alert algorithm will be tested in a randomized trial in bladder cancer patients undergoing chemo- or immunotherapy. The clinical endpoints will be: * Quality of life * Completion of treatment * Hospital admission * Dose reductions * Survival
Detailed description
Bladder cancer is in Europe the 4th most incident cancer among men and the 7th most frequent cause of cancer death. Many patients will receive chemo- or immunotherapy in either the neoadjuvant setting or for recurrent or metastatic disease. The registration and handling of side effect is crucial in bladder cancer treatment, since the missing identification and insufficient treatment of such can lead to incomplete treatment and thereby decreased effect. It is therefore of utmost importance to develop new tools which can increase identification of the side effects and improve treatment to secure the best life expectancies for these patients. This study will in a randomized trial using PRO-CTCAE™ questions, EORTC QLQ-C30 + QLQ-BLM30 in one arm versus standard procedure regarding side effect registration and handling in the other arm, test the effect of electronic reporting of side-effects and quality of life with a specifically developed alert-algorithm. Both study arms will include chemotherapy and immunotherapy patients as standard therapy.
Interventions
DEVICEElectronic patient-reported outcomes
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
Sponsors
Herlev Hospital
Danish Cancer Society
Aalborg University Hospital
Odense University Hospital
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Urothelial carcinoma * Initiating chemo- or immunotherapy * No serious cognitive deficits * Read and understand Danish * Assigned electronic communication with health services with E-boks
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of completion of treatment | Within the first 6 months of treatment | Registration of whether patients complete the planned treatment and if not if the cessation was preventable. |
| Hospital admission | Within the first 6 months of treatment | Registration of whether patients by closer contact to clinic between visits can decrease the rate of hospital admissions for preventable causes during treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaires EORTC QLQ-C30 (general quality of life questionnaire) and EORTC QLQ-BLM30(quality of life questionnaire specifically for muscle-invasive bladder cancer patients) | Within the first 6 months of treatment | Registration of differences in quality of life between the two arms in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) and QLQ-BLM30(scale range 0-100, a higher score indicating increase in symptom burden) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. The EORTC QLQ-BLM30 cannot be applied without the QLQ-C30, hence the aggregation of measures in the present outcome measure category. Differences between the two arms will be tested using t-test and analysis of covariance (ANCOVA). |
| Overall survival measured from time of study initiation to death | Analysis will be made up to 2 years after study completion | Differences in median overall survival and analysis of survival differences between the intervention-arm and the standard of care arm. The analysis will be carried out with log-rank analysis and Kaplan-Meier curves. The analysis will be carried out separately for chemotherapy and immunotherapy recipients. |
| Dose-reductions | Within the first 6 months of treatment | Registration of differences in number of dose reductions of chemotherapy between the two arm in the study. |
Countries
Denmark
Outcome results
None listed