NCT06705491Active, not recruiting
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 7 Feb 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Louisville
- Diseases
- Childhood cancers
- NCT number
- NCT06705491
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 7 Feb 2025 to the primary completion date, 30 Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is not receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic.
Other
- Families not proficient in English.
- Patient is 19 years or older.
- Patient does not have an oncology diagnosis.
- Patient and family have any CPS involvement.
Who the study is looking for
- 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.
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UK DanceBlue Pediatric Hematology & Oncology Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Kentucky Children's Hospital Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Norton Children's Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Norton Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.