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

Not Applicable

Not yet recruiting

• Conditions: Procedural Pain; Cancer-related Pain

• Registration Number: NCT06705491
• Lead Sponsor: University of Louisville

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-26
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Study Start: 2025-01
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Coping Strategies	Pain coping strategies will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).	Families who receive TIPPI-R will report greater use of adaptive pain coping strategies than families in the standard of care condition. This is measured by Survey of Pain Management Practices, Pain Coping Questionnaire-Short Form (Parent and Child), and data abstraction from medical charts. The Survey of Pain Management Practices indicates how often pain management strategies are used over the past 7 days (or since diagnosis). Frequencies are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Scores are calculated by summing the number of strategies used, with higher scores indicating greater frequency of use of adaptive coping strategies. The Pain Coping Questionnaire-Short Form (Child and Parent version) is a 16-item measure to assess how children cope with pain. Items are ranked on a 5-point Likert scale ranging from 1 (never) to 5 (very often). A mean scale score is calculated for each subscale, with higher scores indicating more of the measured construct.

Secondary Outcome Measures

Name	Time	Method
Perceived Pain Intensity	Perceived pain intensity will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).	Patients and families who receive TIPPI-R will report lower perceived intensity of pain experienced by patient than patients and families in the standard of care condition. This outcome will be measured by the Child Pain Characteristics Survey. Children and parent proxy rate worst, least, and average pain over the last 7 days on a scale from 0 (no pain) to 10 (worst possible pain), identify the location(s) of the pain, and indicate what they believe to be the source(s) of the pain.
Pain Catastrophizing	Pain catastrophizing will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).	Patients and families who receive TIPPI-R will report lower rates of pain catastrophizing than patients and families in the standard of care condition. This outcome will be measured by the Pain Catastrophizing Questionnaire-Parent and Child forms. These forms each include13 items across 3 subscales (rumination, magnification, and helplessness), which assess children's catastrophic thoughts and feelings about their pain. Raters indicate the extent to which they/their child experience each of the items using a 5-point Likert type scale ranging from not at all to extremely, with a higher score indicating more catastrophic thinking.
Confidence Managing Pain and Distress	Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).	Patients and families who receive TIPPI-R will report higher confidence facilitating patient coping with pain and distress than families in the treatment as usual condition. This outcome will be measured by the Confidence in Pain Management measure. The child/caregiver will rate three questions on a scale from 0 (not at all confident) to 10 (very confident). Higher numerical rating will indicate greater confidence in pain management.
Distress	Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).	Patients and families who receive TIPPI-R will report lower levels of distress than families in the treatment as usual condition. This outcome will be measured by the Emory Distress Thermometer. Caregiver and child (8 years and older) distress will be measured with 1 item, in which caregivers and patients will each indicate the degree of distress they have been experiencing in the past week ranging from 0 (no distress) to 10 (extreme distress).

Trial Locations

Locations (4)

UK DanceBlue Pediatric Hematology & Oncology; 🇺🇸 Lexington, Kentucky, United States

Kentucky Children's Hospital; 🇺🇸 Lexington, Kentucky, United States

Norton Children's Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Norton Children's Hospital; 🇺🇸 Louisville, Kentucky, United States