Paediatric Breakthrough Pain Assessment

NCT06790719 | Not Yet Recruiting

• 2 other identifiers: 72466V4421
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breakthrough Pain; Palliative Medicine; Oncology Pain; Pediatric ALL; Young People

Keywords

Breakthrough pain; paediatrics; paediatric pain; palliative care; pain assessment

Outcome Measures

Primary Outcomes (2)

• 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.

  From participant enrollment in Study 3 through completion of the final assessment up to 4 weeks later

• 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.

  From participant enrolment in Study 3 through completion of the second assessment 24 hours later

Secondary Outcomes (11)

• Internal consistency of the Breakthrough Pain Assessment Questionnaire (BTPAQ)

  From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later

• Construct validity of the Breakthrough Pain Assessment Questionnaire (BTPAQ)

  From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later

• Discriminant validity of the Breakthrough Pain Assessment Questionnaire (BTPAQ)

  From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later

• Responsiveness of the Breakthrough Pain Assessment Questionnaire (BTPAQ)

  From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later

• Acceptability of the Breakthrough Pain Assessment Questionnaire (BTPAQ)

  From participant enrolment in Study 3 through completion of the final assessment up to 4 weeks later

Study Arms (3)

Children and young people

Children and young people with life limiting or life threatening conditions aged between 8 to 25 years

Parents and caregivers

Parents and carers of children and young people with life limiting or life threatening conditions aged between 3 months and 25 years

Healthcare professionals

Healthcare professionals caring for children and young people with life limiting or life threatening conditions aged between 3 months and 25 years

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).
• Caregivers can be caring for verbal, non-verbal, or pre-verbal children with or without cognitive or developmental difficulties of any level.
• Parents and caregivers must have self-reported full or partial responsibility for assessing the child or young person's pain.
• Healthcare professionals in primary, secondary and tertiary care who are involved in the care of children and young people with life limiting or life threatening conditions (Studies 2 and 3).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southampton: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Related Publications (4)

• Liossi C, Greenfield K, Schoth DE, Mott C, Jassal S, Fraser LK, Rajapakse D, Howard RF, Johnson M, Anderson AK, Harrop E. A Systematic Review of Measures of Breakthrough Pain and Their Psychometric Properties. J Pain Symptom Manage. 2021 Nov;62(5):1041-1064. doi: 10.1016/j.jpainsymman.2021.04.018. Epub 2021 Apr 30.

  PMID: 33933619 RESULT

• Greenfield K, Schoth DE, Hain R, Bailey S, Mott C, Rajapakse D, Harrop E, Renton K, Anderson AK, Carter B, Johnson M, Liossi C. A rapid systematic review of breakthrough pain definitions and descriptions. Br J Pain. 2024 Jun;18(3):215-226. doi: 10.1177/20494637231208093. Epub 2023 Dec 25.

  PMID: 38751563 RESULT

• Dawson E, Greenfield K, Carter B, Bailey S, Anderson AK, Rajapakse D, Renton K, Mott C, Hain R, Harrop E, Johnson M, Liossi C. Definition and Assessment of Paediatric Breakthrough Pain: A Qualitative Interview Study. Children (Basel). 2024 Apr 18;11(4):485. doi: 10.3390/children11040485.

  PMID: 38671702 RESULT

• Greenfield K, Holley S, Schoth DE, Bayliss J, Anderson AK, Jassal S, Rajapakse D, Fraser LK, Mott C, Johnson M, Wong I, Howard R, Harrop E, Liossi C. A protocol for a systematic review and meta-analysis to identify measures of breakthrough pain and evaluate their psychometric properties. BMJ Open. 2020 Mar 29;10(3):e035541. doi: 10.1136/bmjopen-2019-035541.

  PMID: 32229524 RESULT

MeSH Terms

Conditions

Breakthrough Pain; Cancer Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christina Liossi, DPsych

  University of Southampton

  STUDY CHAIR

Central Study Contacts

Georgia Turner, BSc

CONTACT

+44 23 8059 9660; beacon@soton.ac.uk

Christina Liossi, DPsych

CONTACT

+44 2380 594645; cliossi@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 24, 2025
• Study Start: January 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share