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

N/AActive Not RecruitingNCT06705491

University of Louisville100 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Procedural Pain Cancer-related Pain

Interventions

TIPPI-RBEHAVIORAL

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.

Outcomes

Primary Outcomes

Pain Coping Strategies

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.

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

Secondary Outcomes

Perceived Pain Intensity

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.

Time frame: Perceived pain intensity will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).

Pain Catastrophizing

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.

Time frame: Pain catastrophizing will be assessed at baseline (Time 1) and again approximately 4-6 weeks after being consented (Time 2).

Confidence Managing Pain and Distress

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.

Time frame: Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).

Distress

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).

Time frame: Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).