Paediatric Breakthrough Pain Assessment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-99
SponsorUniversity of Southampton
About this trial
Many children and young people with life-limiting and life-threatening illnesses get sudden bursts of pain called breakthrough pain. At the moment, there aren't any good ways to measure this pain in children and young people. The investigators are developing two questionnaires to help: one for patients to fill out themselves and another for parents or healthcare professionals to complete for younger children and young people who cannot explain their pain for themselves.
The investigators plan to work with 210 people across hospitals and hospices in England and Wales. This includes children and young people with life-limiting and life-threatening illnesses, their caregivers, and healthcare professionals. The investigators have already made a first version of the questionnaires.
The project has three main Studies:
In Study 1, the investigators will talk to 5-10 young patients and 5-10 caregivers about their experiences with breakthrough pain. The investigators will use their feedback to improve the questionnaires.
In Study 2, the investigators will ask 5-10 patients, 5-10 caregivers, and 5-10 healthcare professionals to fill out the questionnaires while speaking their thoughts out loud. This will help the investigators find any parts that are confusing or difficult to understand.
In Study 3, the investigators will test how well the questionnaires works. 80 patients, 40 caregivers, and 40 healthcare professionals will complete the questionnaires three different times to make sure they measure breakthrough pain as accurately as possible.
These questionnaire will be useful for hospitals and hospices across England and Wales to help them better manage pain, including breakthrough pain, in patients aged 3 months to 25 years who have life-limiting and life-threatening illnesses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children and young people aged 8-25 years who have experienced 1) background pain related to a life limiting or life threatening condition and 2) around-the-clock analgesia prescribed for the previous week, as confirmed by their healthcare team (Studies 1, 2, and 3).
Children and young people must be able to communicate and read in English at a level close to, or in line with their chronological age.
For study 1, non-verbal children and young people, or those with limited verbal ability, will be recruited if they are happy to participate using the Microsoft Teams chat function.
Parents and caregivers of children and young people aged 3-month-25-years who have experienced 1) background pain related to a life limiting or life threatening condition and 2) around-the-clock analgesia prescribed for the previous week, as confirmed by their healthcare team. (Studies 1, 2, and 3).
Disqualifiers
• Children, young people, parents and caregivers with limited ability to communicate and read in English.
Children and young people judged by caregivers or healthcare professionals to lack capacity to take part, who are too unwell, or might find it too distressing.
Parents and caregivers judged by healthcare professionals to lack capacity to consent, or to be 'struggling' too much. However, if they wish to take part, they can send an email or text message to the study email account or mobile phone.
Trial population
This multicenter study will recruit participants from primary care, pediatric oncology, and palliative care settings across England and Wales, as well as from community settings in the UK.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
210 Participants
are grouped into 3 trial groupsGroup A: Children and young people
Group B: Parents and caregivers
Group C: Healthcare professionals
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of the Breakthrough Pain Assessment Questionnaire (BTPAQ)
Kappa statistic will be calculated to assess agreement between the Breakthrough Pain Assessment Questionnaire (BTPAQ) algorithm's BTP diagnoses and the diagnoses made by doctors responsible for CYP care at Time 1. A kappa value of ≥0.61 will indicate good agreement.
Time frame
From participant enrollment in Study 3 through completion of the final assessment up to 4 weeks later2
Test-retest reliability of the Breakthrough Pain Assessment Questionnaire (BTPAQ)
Intraclass correlation coefficients between Time 1 and Time 2 scores on the Breakthrough Pain Assessment Questionnaire (BTPAQ) will be calculated, with coefficients above 0.8 indicating good test-retest reliability.
Time frame
From participant enrolment in Study 3 through completion of the second assessment 24 hours laterSecondary outcomes
1
Internal consistency of the Breakthrough Pain Assessment Questionnaire (BTPAQ)
Cronbach's alpha coefficients will be calculated for the Breakthrough Pain Assessment Questionnaire (BTPAQ) items, with values \>0.7 indicating good internal consistency.
Time frame
From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later2
Construct validity of the Breakthrough Pain Assessment Questionnaire (BTPAQ)
Scores on the Breakthrough Pain Assessment Questionnaire (BTPAQ) from CYP with participant-rated adequately controlled BTP will be compared to those with inadequately controlled BTP using independent t-tests. Significant group differences (p\<0.05) will indicate construct validity.
Time frame
From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later3
Discriminant validity of the Breakthrough Pain Assessment Questionnaire (BTPAQ)
Correlation coefficients will be calculated between scores on the Breakthrough Pain Assessment Questionnaire (BTPAQ) and unrelated demographic variables (e.g., sex), with low values indicating discriminant validity.
Time frame
From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later4
Responsiveness of the Breakthrough Pain Assessment Questionnaire (BTPAQ)
The minimally important difference (MID) on the Breakthrough Pain Assessment Questionnaire (BTPAQ) will be calculated to determine the smallest value that represents a clinically relevant change in BTP over time. The investigators will calculate the mean difference in BTPAQ scores between Time 1 and Time 3 for all CYP. The MID will be determined by comparing the mean score differences between participants who reported their BTP as "improved" versus those who reported it as "unchanged" from Time 1 to Time 3.
Time frame
From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks laterLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southampton
Lead sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: