Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
NCT06705491

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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