Patient-reported Outcomes in Bladder Cancer (iBLAD)

Rigshospitalet

Status: Completed

Conditions: Bladder Cancer; Urothelial Carcinoma

Treatments: Device: Electronic patient-reported outcomes

Study type: Interventional

Funder types: Other

Identifiers

NCT03584659

iBLAD2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Standard of care

No Intervention group

Description:

This arm will continue standard procedure regarding side effect registration and handling

PRO

Experimental group

Description:

This arm will be assigned to intervention by weekly electronic reporting of side effects and quality of life. A specifically developed alert-algorithm will in real-time guide both patient and alert clinical staff if symptoms are increasing or quality of life is deteriorating.

Treatment:

Device: Electronic patient-reported outcomes