Actively Recruiting
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
Led by University of Louisville · Updated on 2026-01-30
100
Participants Needed
4
Research Sites
94 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
K
Kentucky Cabinet for Health and Family Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Trauma-Informed Procedural Pain Intervention (TIPPI-R) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. The purpose of this clinical trial study is to test how helpful TIPPI-R is in supporting children and families manage pain and distress during the initial stages of cancer treatment. The main questions this study aims to answer are: * Does TIPPI-R increase use of helpful pain coping strategies for pediatric cancer patients? * Does TIPPI-R help lower perceived pain intensity during initial stages of cancer treatment? * Does TIPPI-R increase patient and family confidence in coping with pain and distress during cancer treatment? Researchers will compare pain experiences and use of pain coping strategies for families who receive the TIPPI-R intervention and families who receive standard of care to see if TIPPI-R decrease pain and distress during the initial stages of cancer treatment. Participants will: * Complete surveys to measure pain and distress within 5 weeks of initial diagnosis (Time 1) * Either receive the TIPPI-R intervention or standard of care * Complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery (Time 2)
CONDITIONS
Official Title
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
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Trial Site Locations
Total: 4 locations
1
UK DanceBlue Pediatric Hematology & Oncology
Lexington, Kentucky, United States, 40508
Actively Recruiting
2
Kentucky Children's Hospital
Lexington, Kentucky, United States, 40536
Actively Recruiting
3
Norton Children's Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
4
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
L
Lauren R Hayes, PhD
CONTACT
M
Meghan Marsac, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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