Clinical trial NCT06705491: Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
Official title: Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Procedural Pain
Cancer-related Pain
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Kentucky Cabinet for Health and Family Services
name: University of Kentucky
name: Norton Healthcare
First posted: 2024-11-26
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Coping Strategies
timeFrame: Pain coping strategies will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
Secondary outcomes:
measure: Perceived Pain Intensity
timeFrame: Perceived pain intensity will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
measure: Pain Catastrophizing
timeFrame: Pain catastrophizing will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).
measure: Confidence Managing Pain and Distress
timeFrame: Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
measure: Distress
timeFrame: Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).
Other outcomes:
Locations:
city: Lexington
country: United States
facility: UK DanceBlue Pediatric Hematology & Oncology
state: Kentucky
city: Lexington
country: United States
facility: Kentucky Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Children's Cancer Institute
state: Kentucky
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
Study officials:
affiliation: Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine
name: Lauren R Hayes, PhD
role: PRINCIPAL_INVESTIGATOR
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