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Does a theory and evidence-based approach to implementation increase the uptake of photobiomodulation in U.K. children’s cancer centres?

SPOT-LITE: Study of PhOTobiomodulation impLementation for mucosiTis managEment in childrEn

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12589862
Enrollment
51
Registered
2025-06-30
Start date
2024-05-03
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children's cancer and mucositis Cancer

Interventions

Participants are involved in one of three work-packages: 1. Work-package 1: Participants (healthcare professionals, commissioners, equipment manufacturers, and child-parent dyads) take part in a one-

Sponsors

University of Leeds
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Work-Package 1: Qualitative Interviews 1. Children and Young People 1.1. Children and young people aged 6–17 1.2. Experience of cancer treatment or haematopoietic stem cell transplant 2. Parents 2.1. Individuals with parental responsibility for children meeting the above criteria 3. Healthcare Professionals 3.1. Doctors 3.2. Nurses 3.3. Dentists 3.4. Dental nurses 3.5. Play therapists 4. Wider Stakeholders in Photobiomodulation 4.1. Industry representatives 4.2. Charity representatives 4.3. Commissioners 4.4. Other stakeholders involved in photobiomodulation treatment and NHS implementation 4.5. Note: Sampling will evolve iteratively as analysis progresses Work-Package 2: Co-Design 1. Children and Young People (same as 1.1–1.2 above) 2. Parents (same as 2.1 above) 3. Healthcare Professionals (same as 3.1–3.5 above) 4. Wider Stakeholders in Photobiomodulation (same as 4.1–4.5 above) Work-Package 3: Testing of Implementation Package at Children’s Cancer Centres 1. Children’s Cancer Centres 1.1. Principal Treatment Centres within the Children’s Cancer and Leukaemia Group 1.2. Clinician leads selected based on: 1.2.1. Stage of photobiomodulation implementation (Rogers Adoption Curve) 1.2.2. Geographical area 1.2.3. Number of eligible cases 1.2.4. Presence or absence of specialist Paediatric Dental teams 2. Healthcare Professionals 2.1. Doctors 2.2. Nurses 2.3. Dentists 2.4. Dental nurses 2.5. Play therapists

Exclusion criteria

Exclusion criteria: 1. Children and young people outside of the specified age range 2. Parents and healthcare professionals lacking capacity to consent

Design outcomes

Primary

MeasureTime frame
A mixed-methods approach following the triangulation convergence model is planned, where qualitative findings will be compared to quantitative findings to aid interpretation and improve validity. The key outcome of interest will be successful implementation of photobiomodulation, with experiences determined by qualitative and quantitative data.

Secondary

MeasureTime frame
1. Treatment uptake barriers and facilitators, and need for adaptation, are measured using qualitative semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) during work-package 1 2. Stakeholder feedback on implementation resources from co-design workshops over course of 3 months during work-package 2 3. Reach of photobiomodulation is measured using service-level data on the proportion of eligible children and young people receiving treatment at months 1-6 of work-package 3 4. Severity of mucositis is measured using the World Health Organization Mucositis Grading Scale at months 1-6 of work-package 3 5. Patient-reported mucositis symptoms are measured using the Children’s International Mucositis Evaluation Scale (ChIMES) at month 1-6 of work-package 3 4. Implementation experience is measured using the Stanford Lightning Report Method at fortnightly intervals during the first 3 months of implementation in work-package 3 6. Healthcare professional-reported implementation outcomes are measured using qualitative focus groups guided by the RE-AIM framework at 3-6 months in work-package 3 8. Implementation package usability is measured using qualitative data from lightning reports and focus groups during months 1-6 in work-package 3 10. Feasibility of outcome data collection is measured using completion rates of WHO mucositis grading and ChIMES forms at months 1-6 of work-package 3

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026