Health TrialsbyHealthPanel

Reminder App to Optimize Bladder Filling During Radiotherapy for Prostate Cancer

ConditionProstate Cancer Patients Treated by Radiotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Schleswig-Holstein

About this trial

The primary goal of this study is to assess the impact of an app that reminds patients irradiated for high-risk prostate cancer to drink water prior to each radiotherapy session on the number of bladder volumes \<200 ml during the radiotherapy course and to demonstrate that this number is lower than without using an app (historical control group).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven high-risk prostate cancer

Indication for definitive normo-fractionated radiotherapy

Possession of a smart phone and the ability to use it

Bladder volume at CT-simulation <200 ml

Disqualifiers

Radiotherapy of pelvic lymph nodes

Expected non-compliance

Trial design

Design model

Single group

Treatments tested in this trial

  • Reminder App

    Device

    The purpose of the app is to remind patients irradiated for prostate cancer in an intuitive, unobtrusive and supportive way to drink 300 ml of water 45 minutes prior to each radiation session.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Support by a reminder appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of fractions with bladder volumes <200 ml at 35 fractions

The primary endpoint is the number of radiation fractions with bladder volumes \<200 ml after 35 fractions of radiotherapy. The bladder volume at each radiation fraction are calculated from the corresponding Cone-Beam Computed Tomography (CBCT).

Time frame
through study completion, an average of 7 weeks

Secondary outcomes

1

Number of radiation fractions with bladder volumes <200 ml at the end of radiotherapy

This secondary endpoint is the number of radiation fractions with bladder volumes \<200 ml at the of the radiotherapy course. The bladder volume at each radiation fraction are calculated from the corresponding Cone-Beam Computed Tomography (CBCT).

Time frame
through study completion, an average of 8 weeks
2

Rate of patient satisfaction with the reminder app

Patient satisfaction with the reminder app will be assessed with a specific questionnaire.

Time frame
through study completion, an average of 8 weeks
3

Degree of the impact of the reminder app

Impact of the reminder app on the use of health technology will be assessed with a specific questionnaire.

Time frame
through study completion, an average of 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Schleswig-Holstein

Lead sponsor

University of Southern Denmark

Collaborator

Medical School Hamburg

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: