Trial Title:
The iBlad App - a National, Exploratory Study on a Multimodality Smartphone App for Bladder Cancer Patients
NCT ID:
NCT05710159
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
iBLAD Application to monitor symptoms and quality of life by the use of pateint-reported outcomes
Description:
Development and implementation of a national multimodality application for patients with
bladder cancer that builds upon knowledge from the iBLAD study.
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.
Detailed description:
Design The iBLAD app study is an investigator-initiated, national, Danish multicenter,
exploratory trial connected to the group of bladder cancer responsible specialists at the
six Danish treatment centers. The study is carried out in accordance with the SPIRIT-PRO
Protocol Guidance.
Study plan The app is developed by the app provider Journl who is specialized in ePRO
apps. The app is in Danish. The patient will be able to download the app and create a
user profile when a clinician has registered the patient in Journl's system as a bladder
cancer patient in oncological treatment. After giving informed consent, the patient will
(be helped to) download the app on their private smartphone. The patient will answer the
first questionnaires in relation to the first treatment. The first patient is expected to
be enrolled in December 2022. Patients can use the app as long as treatment is ongoing.
Patients can at any time withdraw their consent and stop using the app. The patient will
receive daily notifications from the app if there is an unanswered questionnaire to
minimize missing data.
Questionnaires In the app, Bladder cancer patients will receive an electronic
questionnaire weekly with selected questions from the PRO-CTCAE library. The questions
have been carefully selected for their specific disease and condition. The epo-CTCAE
questionnaire consists of 15 symptoms comprising of 30 questions on symptoms and side
effects. Each symptom is elicited using between one to three questions on frequency,
severity, and interference with daily activities. Weekly reporting was chosen as this is
the preferred recall period for PRO-CTCAE questionnaires. Depending on the patients´
response and due to predefined thresholds, the patient will get feedback for supportive
care or be advised to contact the hospital. Moreover, the patients will be asked to
complete EORTC QLQ-C30 and EORTC QLQ-BLM30 monthly to monitor their QoL (see
supplementary material). All electronic questionnaires will be completed at home. An
expert group, consisting of nurses and clinicians, has selected the questionnaires as the
most relevant questionnaires for this patient population.
Patient feedback and inclusion in the clinical encounter The questionnaires are the same
regardless of the patient's oncological treatment but is developed to cover both
chemotherapy and ICI. The patients receive immediate feedback in the app as they complete
the symptom questionnaire. The advice given can continuously be found in the app. The
advice is based on an algorithm linked to the severity of the symptoms or side effects
that the patient reports. The algorithm including type of intervention was developed by
the expert group. The symptom and QoL scores are also sent to the hospital where the
clinician can access the patient reporting and are trained and prompted to review the
scores at patient visits. Thus, the patient reporting not only serves as a reflection of
the patient's condition to be used for research purposes but can also be used as a
dialogue tool during the clinical encounter. Accordingly, the app will enable regular
symptom tracking, feedback to patients and QoL reporting to achieve earlier symptom
management and improved supportive care. The ePRO questionnaires are added to standard of
care and the symptoms highlighted will be treated in alignment with standard procedures.
In routine care, clinicians carry out toxicity registration prior to each cycle of
anti-neoplastic treatment, typically every three or four weeks. The weekly patient
reporting in the app takes place at home in between visits to the hospital. Alert
algorithms and thresholds for alerts can be seen in Supplementary material.
Patient videos In addition to completing questionnaires in the app, the patients will
also gain access to a variety of short videos with former bladder patients recruited from
the Danish bladder cancer organization. The subjects of the videos were decided on during
a workshop carried out with six bladder cancer patients who had all received
anti-neoplastic treatment. Thus, the participants in the workshop took part in deciding
what the app should contain in terms of informative and relevant video material on the
experiences of bladder cancer patients. Fifty-three videos will be produced with five
bladder cancer patients (three men and two women). In the videos, the patients share
peer-to-peer insights on how they experience being bladder cancer patients, covering a
wide range of topics such as living with cancer, operation, treatment, sexual issues,
family relations, rehabilitation and quality of life.
Evaluation Patients will receive questionnaires on symptoms and QoL as long as treatment
is ongoing. After 4 weeks of treatment, the patients will be asked to complete a
validated Patient-Reported Experience Measure in the clinic to evaluate acceptability of
the app. In addition, individual interviews will be performed with participants in the
study from all six centers where usability and patient satisfaction is evaluated.
Endpoints Primary outcome is PRO symptoms´ correlation to QoL measured by EORTC-QLQ-C30
and the specific bladder cancer questionnaire EORTC-QLQ-BLM-30 and submodules of these.
Additionally, specific PRO symptoms development over time and time-dependency in relation
to QoL will be investigated. The study is non-comparative and analyses will be
exploratory. Secondary endpoints will be level of user acceptability and patient
satisfaction.
Sample size No sample size calculation has been performed due to the study's explorative
nature. To secure a broad geographic representation the aim is to include at least 100
patients with a minimum of 10 patients from each of the six centers. The study will be
analyzed when 100 patients have been followed for at least 3 months. An interim analyses
will be performed after 30 included patients primarily to evaluate compliance and
adherence to the app.
Data collection and statistics Information on age, time of diagnosis, gender, histology,
TNM stage, treatment type, treatment line and performance status will be noted. A
baseline questionnaire on symptoms and QoL will be completed. The analyses of ePRO data
will include descriptive statistics for both changes from baseline and observed scores
after 1, 2, 3, 4, 5 and 6 months of participation in the study. In case of missing data,
imputation will not take place. PRO-data will be monitored regularly, in the beginning on
a weekly basis. After 12 weeks, we will shift to monthly monitoring if adherence is
acceptable. If patients do not comply with the study protocol, they will be contacted by
the project manager and/or withdrawn from the study. Eligible patients will be informed
about this upon enrolment and that it will have no impact on their treatment.
Ethics declaration The iBLAD app study was exempt for review by the Medical Research
Ethics Committee, will follow General Data Protection Regulation, and is registered at
the Capital Region of Denmark. The results of the study will be reported in a scientific
journal.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Helle Pappot, Professor
Email:
helle.pappot@regionh.dk
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Lærke Tolstrup, PhD
Phone:
+ 45 40295129
Email:
laerke.tolstrup@rsyd.dk
Start date:
December 12, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Odense University Hospital
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Source:
Odense University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05710159
