Trauma-informed program to reduce procedure-related pain and distress in children with cancer
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
This project will test a trauma-informed program called TIPPI-R to help children with cancer and their families manage pain and distress during early treatment procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 4 sites (Lexington, Kentucky and 3 other locations) |
| Trial ID | NCT06705491 on ClinicalTrials.gov |
What this trial studies
TIPPI-R is a standardized, trauma-informed intervention that provides education and teaches evidence-based coping strategies for managing pain and distress during pediatric cancer procedures. Families who receive TIPPI-R will be compared with families receiving standard care to measure differences in use of pain-coping strategies, reported pain intensity, and caregiver/child confidence. The trial enrolls children aged 0–18 with an oncology diagnosis and their families at participating pediatric oncology centers in Kentucky. Outcomes are collected during the initial stages of cancer treatment using parent- and child-reported measures of pain, coping strategy use, and confidence.
Who should consider this trial
Good fit: Children aged 0–18 with a cancer diagnosis who are English-speaking, have no CPS involvement, and are receiving care at one of the participating Kentucky pediatric oncology centers are ideal candidates.
Not a fit: Patients 19 or older, non–English-speaking families, those with CPS involvement, or those not receiving care at the participating centers would not be eligible and likely would not benefit from this intervention.
Why it matters
Potential benefit: If successful, TIPPI-R could lower procedure-related pain and distress and increase families' confidence and use of effective coping strategies during cancer treatment.
How similar studies have performed: Previous research shows that education and coping-skills interventions can reduce pediatric procedural pain, though fully trauma-informed packages like TIPPI-R are newer and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic. * Patient has been diagnosed with an oncology diagnosis. * Patient and family are English-speaking. * Patient is between the ages 0-18. Exclusion Criteria: * Families not proficient in English. * Patient is 19 years or older. * Patient is not receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic. * Patient does not have an oncology diagnosis. * Patient and family have any CPS involvement.
Where this trial is running
Lexington, Kentucky and 3 other locations
- UK DanceBlue Pediatric Hematology & Oncology — Lexington, Kentucky, United States (Recruiting)
- Kentucky Children's Hospital — Lexington, Kentucky, United States (Recruiting)
- Norton Children's Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Norton Children's Hospital — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Lauren R Hayes, PhD — Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine
- Study coordinator: Lauren R Hayes, PhD
- Email: lauren.hayes@louisville.edu
- Phone: 502-588-0800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.