Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol (TIPPI-R)

University of Louisville (UOFL)

Status: Enrolling

Conditions: Cancer-related Pain; Procedural Pain

Treatments: Behavioral: TIPPI-R

Study type: Interventional

Funder types: Other

Identifiers

NCT06705491

24.0284

Details and patient eligibility

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)

Enrollment: 100 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

TIPPI-R

Experimental group

Treatment:

Behavioral: TIPPI-R

Standard of Care

No Intervention group

Description:

Participants and families in this arm will receive the standard treatment for pain and distress during cancer treatment at each respective institution, which may include psychoeducation and support implementing pain coping skills from mental health providers within the healthcare system.

Delayed Intervention Delivery

Experimental group

Description:

Participants will be moved into this arm if they are initially randomized into the intervention arm, but they receive the TIPPI-R intervention outside of the window dictated in the protocol. According to the protocol, consented participants should receive the interventions within 2 weeks of consent. If they do not, the TIPPI-R intervention will still be delivered and the participant will be moved to this arm of the study.

Treatment:

Behavioral: TIPPI-R