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

NCT06705491 | Recruiting

• 1 other identifier: 24.0284
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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)

Conditions

Procedural Pain; Cancer-related Pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• Perceived Pain Intensity

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

• Pain Catastrophizing

  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

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

• Distress

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

Study Arms (3)

TIPPI-R

EXPERIMENTAL

Behavioral: TIPPI-R

Standard of Care

NO INTERVENTION

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

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.

Behavioral: TIPPI-R

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.

Delayed Intervention Delivery; TIPPI-R

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• University of Kentucky: collaborator
• Kentucky Cabinet for Health and Family Services: collaborator
• Norton Healthcare: collaborator

Study Sites (4)

UK DanceBlue Pediatric Hematology & Oncology

Lexington, Kentucky, 40508, United States

RECRUITING

Kentucky Children's Hospital

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Children's Cancer Institute

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (16)

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  PMID: 28678061 BACKGROUND

• O'Donnell FT, Rosen KR. Pediatric pain management: a review. Mo Med. 2014 May-Jun;111(3):231-7.

  PMID: 25011346 BACKGROUND

• Tonning Olsson I, Alberts NM, Li C, Ehrhardt MJ, Mulrooney DA, Liu W, Pappo AS, Bishop MW, Anghelescu DL, Srivastava D, Robison LL, Hudson MM, Ness KK, Krull KR, Brinkman TM. Pain and functional outcomes in adult survivors of childhood cancer: A report from the St. Jude Lifetime Cohort study. Cancer. 2021 May 15;127(10):1679-1689. doi: 10.1002/cncr.33303. Epub 2020 Dec 28.

  PMID: 33369896 BACKGROUND

• Schwartz LA, Brumley LD. What a Pain: The Impact of Physical Symptoms and Health Management on Pursuit of Personal Goals Among Adolescents with Cancer. J Adolesc Young Adult Oncol. 2017 Mar;6(1):142-149. doi: 10.1089/jayao.2016.0031. Epub 2016 Oct 28.

  PMID: 27792462 BACKGROUND

• Price J, Kassam-Adams N, Alderfer MA, Christofferson J, Kazak AE. Systematic Review: A Reevaluation and Update of the Integrative (Trajectory) Model of Pediatric Medical Traumatic Stress. J Pediatr Psychol. 2016 Jan-Feb;41(1):86-97. doi: 10.1093/jpepsy/jsv074. Epub 2015 Aug 28.

  PMID: 26319585 BACKGROUND

• Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.

  PMID: 31532518 BACKGROUND

• Kearney JA, Salley CG, Muriel AC. Standards of Psychosocial Care for Parents of Children With Cancer. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5(Suppl 5):S632-83. doi: 10.1002/pbc.25761.

  PMID: 26700921 BACKGROUND

• Uhl K, Burns M, Hale A, Coakley R. The Critical Role of Parents in Pediatric Cancer-Related Pain Management: a Review and Call to Action. Curr Oncol Rep. 2020 Mar 14;22(4):37. doi: 10.1007/s11912-020-0899-7.

  PMID: 32172378 BACKGROUND

• Marsac ML, Kassam-Adams N, Hildenbrand AK, Nicholls E, Winston FK, Leff SS, Fein J. Implementing a Trauma-Informed Approach in Pediatric Health Care Networks. JAMA Pediatr. 2016 Jan;170(1):70-7. doi: 10.1001/jamapediatrics.2015.2206.

  PMID: 26571032 BACKGROUND

• Stehl ML, Kazak AE, Alderfer MA, Rodriguez A, Hwang WT, Pai AL, Boeving A, Reilly A. Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. J Pediatr Psychol. 2009 Sep;34(8):803-16. doi: 10.1093/jpepsy/jsn130. Epub 2008 Dec 17.

  PMID: 19091806 BACKGROUND

• Kazak AE, Hocking MC, Ittenbach RF, Meadows AT, Hobbie W, DeRosa BW, Leahey A, Kersun L, Reilly A. A revision of the intensity of treatment rating scale: classifying the intensity of pediatric cancer treatment. Pediatr Blood Cancer. 2012 Jul 15;59(1):96-9. doi: 10.1002/pbc.23320. Epub 2011 Aug 19.

  PMID: 21858914 BACKGROUND

• Stinson JN, Jibb LA, Nguyen C, Nathan PC, Maloney AM, Dupuis LL, Gerstle JT, Hopyan S, Alman BA, Strahlendorf C, Portwine C, Johnston DL. Construct validity and reliability of a real-time multidimensional smartphone app to assess pain in children and adolescents with cancer. Pain. 2015 Dec;156(12):2607-2615. doi: 10.1097/j.pain.0000000000000385.

  PMID: 26580680 BACKGROUND

• Kohut SA, Stinson J, Chambers CT, Reid GJ, Pillai Riddell RR. The Pain Coping Questionnaire short-form: preliminary reliability and validity. Pain Rep. 2022 Jan 12;7(1):e982. doi: 10.1097/PR9.0000000000000982. eCollection 2022 Jan-Feb.

  PMID: 35047713 BACKGROUND

• Reid GJ, Gilbert CA, McGrath PJ. The Pain Coping Questionnaire: preliminary validation. Pain. 1998 May;76(1-2):83-96. doi: 10.1016/s0304-3959(98)00029-3.

  PMID: 9696461 BACKGROUND

• Goubert L, Eccleston C, Vervoort T, Jordan A, Crombez G. Parental catastrophizing about their child's pain. The parent version of the Pain Catastrophizing Scale (PCS-P): a preliminary validation. Pain. 2006 Aug;123(3):254-263. doi: 10.1016/j.pain.2006.02.035. Epub 2006 Apr 27.

  PMID: 16644128 BACKGROUND

• Caes L, Goubert L, Devos P, Verlooy J, Benoit Y, Vervoort T. The relationship between parental catastrophizing about child pain and distress in response to medical procedures in the context of childhood cancer treatment: a longitudinal analysis. J Pediatr Psychol. 2014 Aug;39(7):677-86. doi: 10.1093/jpepsy/jsu034. Epub 2014 Jun 6.

  PMID: 24906963 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren R Hayes, PhD

  Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren R Hayes, PhD

CONTACT

502-588-0800; lauren.hayes@louisville.edu

Meghan Marsac, PhD

CONTACT

meghan.marsac@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: February 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)