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

The RELIEF-study was initiated in response to a study carried out at the Sophia
Children*s Hospital in Rotterdam (Simon et al., 2020. Pain at Home During
Childhood Cancer Treatment. Severity, Prevalence, Analgesic Use and
Interference with Daily Life, Pediatric Blood and Cancer). In this study, pain
was assessed in children with cancer receiving chemotherapy at the outpatient
clinic. The majority of children experienced clinically significant pain at
home and families frequently indicated that no medication was used to manage
pain. As a result, the KLIK Pijnmonitor app was developed to decrease pain in
children with cancer at home. The app provides families with professional help
and educa-tional information to improve pain management in the home setting.

In the RELIEF-1 study, feasibility of the app, adherence to the app, user
experiences with the app, and determinants of implementation were assessed in a
small group of families (N=27) and healthcare professionals (HCP*s) (N=7)
(Simon et al., in preparation for publica-tion). Results were used to further
improve the KLIK Pijnmonitor app and the processes in-volved.

In the RELIEF-2 study, effectiveness of the app will be assessed in order to
answer the question: do children who use the app experience less clinically
significant pain (i.e. score >4 on *worst pain* or *average pain in the last 24
hours*) at home than children who do not use the app (i.e. receive care as
usual)? We hypothesize that children who have the app at their disposal
(intervention group) experience 20% less clinically significant pain at home
than children who do not use the app (control group).

Primary objective is to investigate the effectiveness of the KLIK Pijnmonitor
in reducing clinically significant pain in children at home by comparing the
proportion of clinically significant pain between the intervention group and
the control group.

Secondary objectives are as follows:

- To study the effect of the KLIK Pijnmonitor on children*s pain severity, pain
duration, pain management strategies, and interference of pain with daily
life;
- To study the effect of the KLIK Pijnmonitor on children*s health related
quality of life (HRQoL);
- To study the effect of the KLIK Pijnmonitor on parental emotional well-being
(distress, anxiety, depression and anger);
- To assess whether app use yields to less consultations with the hospital
regarding pain;
- To assess determinants of implementation of the KLIK Pijnmonitor app (i.e.
barriers and facilitators) and explore strategies to further improve the app
and future implementation, by evaluating the app with families and HCP*s.

In this Randomized Controlled Trial (RCT), children will be recruited and
randomly assigned to either the intervention or control group. Before group
allocation questionnaires will be completed - among which a baseline pain
assessment questionnaire - which will be used to control for possible disparity
in pain characteristics per group. During the three week study period, the
intervention group will have the KLIK Pijnmonitor app at their disposal, and
the control group will continue to receive care as usual. In week 3, another
set of questionnaires will be completed, the results of which will be used to
answer the primary (and part of the) secondary research questions. The
questionnaires conducted before the start and during the third week of the
study focus on pain characteristics, children*s health related quality of life,
parental emotional well-being, and finally HCP*s and families' attitudes
towards the app (i.e. determinants of implementation).

The intervention group will have the KLIK Pijnmonitor app at their disposal.
This includes the opportunity (note: not requirement) to report pain intensity
whenever a child is in pain and therewith receive feedback from HCP*s when pain
is clinically significant. Moreover, the app features educational information
about pain(management). The control group does not have the app at their
disposal, but continues to receive care as usual (i.e. families are responsible
for contacting the hospital themselves when their child is in pain.

Risks and burden of participation can be considered as minimal. Participation
contains the following:

- For all participants (both control- and intervention group): The completion
of questionnaires both at baseline and after completion of the study;
- For participants in the intervention group: The possibility of reporting pain
intensity when a child is in pain, and subsequently receiving feedback from
HCP*s for clinically significant pain.