The iBlad App - a National, Exploratory Study on a Multimodality Smartphone App for Bladder Cancer Patients

NCT05710159 | Recruiting

• 1 other identifier: R261-A16126
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aims of this project are:

• to develop and implement a national multimodality application for patients with bladder cancer that builds upon knowledge from the iBLAD study.
• to investigate how the app, containing PRO questions on symptoms and QoL, information for health care providers, and peer-to-peer advice, can provide more knowledge on symptoms, QoL, and the need for supportive care.
• to examine the usability of and patient satisfaction with the app using qualitative methods.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Development and implementation of the iBLAD-app

  To develop and implement a national multimodality application (app) for patients with bladder cancer t

  2 years

Secondary Outcomes (2)

• App contributions

  2 years

• Usability and evaluation

  2 years

Interventions

iBLAD Application to monitor symptoms and quality of life by the use of pateint-reported outcomes DEVICE

Development and implementation of a national multimodality application for patients with bladder cancer that builds upon knowledge from the iBLAD study.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bladder cancer defined as both urothelial tract-, bladder- and urethral cancer initiating first or second-line standard therapy with either chemotherapy or immunotherapy

You may qualify if:

• Patients with bladder cancer defined as both urothelial tract-, bladder- and urethral cancer initiating first or second-line standard therapy with either chemotherapy or immunotherapy
• Age ≥ 18 years,
• Performance status ≤ 2
• Ability to read Danish
• No serious cognitive impairment
• Informed consent.

You may not qualify if:

• No smartphone,
• Dementia, mental alteration, or psychiatric disease that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial.

Sponsors & Collaborators

• Odense University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Danish Cancer Society: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (4)

• Taarnhoj GA, Lindberg H, Johansen C, Pappot H. Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience. J Clin Med. 2021 Apr 24;10(9):1852. doi: 10.3390/jcm10091852.

  PMID: 33923176 BACKGROUND

• Taarnhoj GA, Johansen C, Lindberg H, Basch E, Dueck A, Pappot H. Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease. Cancer Med. 2020 May;9(9):3078-3087. doi: 10.1002/cam4.2958. Epub 2020 Mar 10.

  PMID: 32154663 BACKGROUND

• Taarnhoj GA, Lindberg H, Dohn LH, Omland LH, Hjollund NH, Johansen C, Pappot H. Electronic reporting of patient-reported outcomes in a fragile and comorbid population during cancer therapy - a feasibility study. Health Qual Life Outcomes. 2020 Jul 11;18(1):225. doi: 10.1186/s12955-020-01480-3.

  PMID: 32653005 BACKGROUND

• Taarnhoj GA, Lindberg H, Johansen C, Pappot H. Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy. J Patient Rep Outcomes. 2019 Aug 22;3(1):56. doi: 10.1186/s41687-019-0141-2.

  PMID: 31440865 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Helle Pappot, Professor

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helle Pappot, Professor

CONTACT

+ 45 35454089; helle.pappot@regionh.dk

Lærke K Tolstrup, PhD

CONTACT

+ 45 40295129; laerke.tolstrup@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: February 2, 2023
• Study Start: December 12, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

DK (2)