GAPP project, she explained the CCI role in the project and presented the patient information material for both GABA-1 and GABA-2 trials.

1. Patty Brouwer
7th European CCI meeting, Belgrade
22 April 2016

2. Background:Why this study?
Suffering from (chronic) pain can limit a child’s
ability to attend school, socialize and
participate in physical activity.
Studies suggest that many children do not
receive appropriate help or pain treatment, and
are often undertreated
(Goodman JE and McGrath PJ, 1991; Perquin CW et al., 2000; Schanberg LE et al., 2003).

3. Background:Why this study?
Pain is one of the most frequent and serious
symptoms experienced by patients in need of
palliative care
80% of the world’s population lack adequate
access to medication need for palliative care

4. Pain treatment in children
WHO guidelines on the pharmacological
treatment of persisting pain in children with
medical illnesses (including cancer), 2012:
1. mild pain: paracetamol/acetaminophen and
ibuprofen (non opioids)
2. moderate to severe pain: morphine

5. WHO
1st priority is to find strong opioids as an
alternative for morphine or as a complimentary
drug to morphine
2nd priority is the search for drugs to reduce
neuropathic pain.Among these drugs,
gabapentin is specifically listed.

6. GABAPENTIN
• anti epileptic
• used in adults for neuropathic pain treatment
• for adults proven to bring great benefit, good
results
• expected to bring great benefit to children for
whom very few approved medication are
available for the treatment of pain

7. Why is CCI involved?
Pain is one of the most common symptoms in
children with cancer.
About 40% of cancer-related pain is
neuropathic pain.
A Parent’s Guide to Enhancing the Quality of Life in
Children with Cancer, Chapter 4 Pain in Children with Cancer,
2014 by Ruth I Hoffman MPH and Sandra E Smith

8. Why is CCI involved?
Most of the included children in this trial will be
oncology patients.
For many parents pain is
one of the most concerning
and frightening aspects of
the journey.

9. One of CCI’s visions
CCI wants to ensure that children receive the
best possible care (pain treatment) wherever
they are in the world at the time of diagnosis
and beyond

10. Final Goal of GAPP
To propose a treatment of chronic pain with a
neuropathic component in children with
gabapentin both as monotherapy and as
additional therapy to morphine
To assess the safety of gabapentin in children

11. CCI’s participation in GAPP

12. Complicated trials
• Children need to be woken up every 4 hours:
burden on child and parent during 17-21 weeks
• Large quantities of liquids of a nasty tasting
substance
• Challenge to include enough children
• Possibly high withdrawal rates for inefficacy or
adverse drug events

13. CCI’s participation in GAPP
• Ethic committee:
Anouk Nijenhuis: CCI andVOKK
2 Study Protocols, Information Document, Annex on side effects
of drugs, Consent form, Letter for the primary care
doctor/paediatrician for informing the parents and patients.

14. CCI’s participation in GAPP
• Scientific committee:
Marcela Zubieta: CCI board member
• PatientAdvisory Board (PAB): to provide input with
attention to patient perspective on GAPP project
Anouk Nijenhuis: CCI andVOKK
Patty Brouwer: CCI andVOKK

15. GAPP Patient Advisory Board (PAB)
The PAB aims to assess all relevant aspects of
the GAPP project from the patient perspective,
including patient information material for
both GABA-1 (WP 7) and GABA-2 (WP 8) trials
• Booklets: to help children to decide in
participation
• Video: explanation of trials in general
• Patient diary: children at home and record
pain scores

16. Focus Groups used for patients
perspective
• Children 6-11 and 12-17 years old (<6 not
included)
• 3 booklets for 3 age groups
• 2 countries: Italy and the Netherlands
• Italy: children's hospital Padova
• The Netherlands: pain department Rotterdam
andVOKK

17. Patient information booklets
FOCUS GROUP KEY QUESTIONS
• General question on what each page depicts
• Specific questions regarding key information
– Purpose of study: well understood
– Chronic vs. acute pain: in general well understood
but 9-11 struggled

18. Focus group key questions
– Study stages and procedures:
12-17: too busy, too much information

19. Focus group key questions
– Disadvantages, possible side effects: concept
very clear, too many pages, disturbing drawings

20. Focus group key questions
• Reasons to participate: well understood, also
that it might not help them
• Withdrawal from study
Emphasize ability to withdraw
at any time and how
• Privacy and consent
Appreciate that data will be kept
private.
Understand that only doctor and parents
will know if a child participates.

21. Resulting revisions to booklets
• 12-17 year old booklet
– Change “Generation GAPP” in title

22. Overall conclusions
• Patient information booklets clear and enjoyable
to read for the children
• Helpful minor revisions suggested
• Important themes identified for further
discussion with treating physician:
– Blood draws (frequency, how long)
– Randomization, blinding, placebo
– Urine test/pregnancy
– Study withdrawal procedures

23. Next step
• Including children in trials in:
Albania
Estonia
France
Greece
Germany
Italy
the Netherlands
United Kingdom
• Hand out of information booklets

24. Contacts
For more information contact:
Coordinator: Dr. Donato Bonifazi of the
Consorzio perValutazioni Biologiche e
Farmacologiche (CVBF) gapp@cvbf.net
Patty Brouwer
headoffice@cci.care