NCT03584659

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2.7 years

First QC Date

June 21, 2018

Last Update Submit

October 24, 2022

Conditions

Bladder CancerUrothelial Carcinoma

Keywords

Patient-reported outcomesElectronic reporting of symptomsImmunotherapyChemotherapy

Outcome Measures

Primary Outcomes (2)

  • Rate of completion of treatment

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

    Within the first 6 months of treatment

  • Hospital admission

    Registration of whether patients by closer contact to clinic between visits can decrease the rate of hospital admissions for preventable causes during treatment.

    Within the first 6 months of treatment

Secondary Outcomes (3)

  • 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

  • Overall survival measured from time of study initiation to death

    Analysis will be made up to 2 years after study completion

  • Dose-reductions

    Within the first 6 months of treatment

Study Arms (2)

Standard of care

NO INTERVENTION

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

PRO

EXPERIMENTAL

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.

Device: Electronic patient-reported outcomes

Interventions

Electronic patient-reported outcomesDEVICE

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

Also known as: Alert-algorithm, Real-time guidance of patients when symptom reporting, Alerts to clinical staff
PRO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urothelial carcinoma
  • Initiating chemo- or immunotherapy
  • No serious cognitive deficits
  • Read and understand Danish
  • Assigned electronic communication with health services with "E-boks"

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Department of Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Oncology

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • Taarnhoj GA, Johansen C, Carus A, Dahlrot RH, Dohn LH, Hjollund NH, Knudsen MB, Tolver A, Lindberg H, Pappot H. The iBLAD study: patient-reported outcomes in bladder cancer during oncological treatment: a multicenter national randomized controlled trial. J Patient Rep Outcomes. 2023 Oct 9;7(1):99. doi: 10.1186/s41687-023-00640-5.

    PMID: 37812306DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Gry Assam Taarnhøj, MD

    Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Oncologist, Consultant, DMSc

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 12, 2018

Study Start

January 21, 2019

Primary Completion

September 30, 2021

Study Completion

March 31, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(4)