Reducing Pain in Pediatric Oncology Patients at Home. Effectiveness of the KLIK Pijnmonitor App

Completed

Conditions: Pijnklachten als gevolg van (de behandeling van) kinderkanker
Treatment- and illness related pain in pediatric oncology

Registration Number: NL-OMON51187

Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 168

Inclusion Criteria

All children between the ages of 0 - 18 years old who are in active treatment
at the Princess Máxima Center for Pediatric Oncology are eligible for this
study. Furthermore, study participants (patient or parent) have to understand
and speak the Dutch language. Also, they need to have a smartphone on which the
app can be downloaded (available via the Apple Store and Google Play Store).

Exclusion Criteria

Due to the switch from *Huawei Mobile Services* to its own operating system -
forced by new US legislation that prohibits this company from using Google
Mobile Services in Android -
users of Huawei phones currently cannot receive pop-up notifications from apps.
As a result, an important function of the KLIK Pain Monitor app (the daily
reminders to score pain set by users themselves) will be lost. In order to
reliably test the effectiveness of the app, all users need to have access to
the same functionalities. As Huawei is not expected to provide a solu-tion on
short term, we have chosen to exclude Huawei-users from this study. Data
collected by the app developer based on another app they built (650.000 users)
shows that roughly 6% uses a Huawei phone. We do not expect that this measure
will influence the results of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the prevalence of clinically significant pain.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include children*s pain severity, pain duration,<br /><br>pain management strategies, interference of pain with daily life, Health<br /><br>Related Quality of Life (HRQoL), parental emotional well-being, and HCP's and<br /><br>families' attitudes towards the app (determinants of implementation: barriers<br /><br>and facilitators). This will all be assessed using questionnaires. Furthermore,<br /><br>data from the electronic patient dossier (EPD/HIX) will be used to assess the<br /><br>amount of consultations each group (intervention and control) had with the<br /><br>hospital regarding pain, apart from the app (i.e. parents calling the hospital<br /><br>or discussing pain with nurse or oncologist during hospital visits).</p><br>