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Completed

NCT Number: NCT03584659

Patient-reported Outcomes in Bladder Cancer

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

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic patient-reported outcomes

Device

Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.

Other names: Alert-algorithm, Real-time guidance of patients when symptom reporting, Alerts to clinical staff

Primary outcomes

  1. Rate of completion of treatment

    Time frame: Within the first 6 months of treatment

    Registration of whether patients complete the planned treatment and if not if the cessation was preventable.

  2. Hospital admission

    Time frame: 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 outcomes

  1. 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)

    Time frame: 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).

  2. Overall survival measured from time of study initiation to death

    Time frame: 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.

  3. Dose-reductions

    Time frame: Within the first 6 months of treatment

    Registration of differences in number of dose reductions of chemotherapy between the two arm in the study.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Danish Cancer Society
  • Herlev Hospital
  • Odense University Hospital

Registry information

Official study title

Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study

Acronym: iBLAD

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 12, 2018
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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