Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol

Summary

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

• Procedural Pain
• Cancer-related Pain

Interventions

BEHAVIORAL

TIPPI-R

The TIPPI-R intervention protocol consists of a one session, during which time the interventionist offers psychoeducation related to the following content areas: procedural pain related to oncology treatment, factors that may affect the perception of pain, evidenced-based tools for assessing and monitoring pain, cognitive and behavioral pain management interventions, and resources to facilitate family to advocacy for pain management in a medical setting. During this session, the interventionist discusses opportunities for families to utilize skills throughout treatment, and addresses family questions as needed. A follow-up session 4 weeks after the initial intervention session will assess family knowledge and skills and offer a referral for a mental health provider, if further pain management support is needed. TIPPI-R is designed to be delivered by a psychologist, psychology trainee, or social worker working in the oncology context.

Sponsors & Collaborators

• Kentucky Cabinet for Health and Family Services

  collaborator UNKNOWN

• University of Kentucky

  collaborator OTHER

• Norton Healthcare

  collaborator OTHER

• University of Louisville

  lead OTHER

Principal Investigators

• Lauren R Hayes, PhD · Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-07

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• United States

Study Locations