Clinical trial · Interventional
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Pain | — | UNRESOLVED | — |
| Procedural Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TIPPI-R | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- TIPPI-R
- interventionNames
- Behavioral: TIPPI-R
- type
- NO_INTERVENTION
- label
- Standard of Care
- 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.
- type
- NO_INTERVENTION
- label
- Non-receipt of intervention
- description
- Participants will be moved into this arm if they are initially randomized into the intervention arm, but they do not receive the TIPPI-R intervention within the allocated window dictated in the protocol. According to the protocol, consented participants should receive the interventions within 3 weeks of consent. If they do not, the TIPPI-R intervention will not be delivered and the participant will be moved to this arm of the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (16)
- BACKGROUNDTutelman 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
- BACKGROUNDO'Donnell FT, Rosen KR. Pediatric pain management: a review. Mo Med. 2014 May-Jun;111(3):231-7. PMID 25011346
- BACKGROUNDTonning 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
- BACKGROUNDSchwartz 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
- BACKGROUNDPrice 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
- BACKGROUNDRosenberg 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
- BACKGROUNDKearney 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.