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

Conditions

• Cancer-related Pain
• Procedural Pain

Eligibility Criteria

Sex

ALL

Age

N/A - 18 Years

Healthy Volunteers

Not accepted

Interventions

• TIPPI-R — BEHAVIORAL
  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.

Study Details

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)

Key Dates

Start date

Feb 7, 2025

Status verified

Jan 2026

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: TIPPI-R
• No Intervention: Standard of Care
  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.
• Experimental: Delayed Intervention Delivery
  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.

Primary Outcome Measure

Pain Coping Strategies [ Time Frame: Pain coping strategies will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2). ]

Central Contacts

• Lauren R Hayes, PhD
  502-588-0800
  [email protected]
• Meghan Marsac, PhD
  [email protected]

Locations (4)

Find similar trials in Lexington, KY

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