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Recruiting NCT06705491

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

No phase Interventional Procedural Pain Cancer-related Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TIPPI-R.
Who it may be relevant to
Registry conditions: Procedural Pain, Cancer-related Pain. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Interventions

  • Behavioral TIPPI-R
    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

Primary outcome measures

  • 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).]
Secondary outcome measures (4)
  • Perceived Pain Intensity [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 [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 [Time frame: Confidence managing pain and distress will be assessed at baseline and again approximately 4-6 weeks after being consented (Time 2).]
  • Distress [Time frame: Distress will be assessed at baseline and again approximately 4-6 weeks after being consented (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 4 centers
  • UK DanceBlue Pediatric Hematology & Oncology — Lexington
  • Kentucky Children's Hospital — Lexington
  • Norton Children's Cancer Institute — Louisville
  • Norton Children's Hospital — Louisville

Publications

  • Tutelman PR, Chambers CT, Stinson JN, Parker JA, Fernandez CV, Witteman HO, Nathan PC, Barwick M, Campbell F, Jibb LA, Irwin K. Pain in Children With Cancer: Prevalence, Characteristics, and Parent Management. Clin J Pain. 2018 Mar;34(3):198-206. doi: 10.1097/AJP.0000000000000531. PMID 28678061
  • O'Donnell FT, Rosen KR. Pediatric pain management: a review. Mo Med. 2014 May-Jun;111(3):231-7. PMID 25011346
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06705491 · 24.0284

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗