Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol
NCT ID: NCT06705491
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-01-31
2026-12-31
Brief Summary
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* 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)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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TIPPI-R
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 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.
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.
No interventions assigned to this group
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.
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 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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* Patient has been diagnosed with an oncology diagnosis.
* Patient and family are English-speaking.
* Patient is between the ages 0-18.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Kentucky Cabinet for Health and Family Services
UNKNOWN
University of Kentucky
OTHER
Norton Healthcare
OTHER
University of Louisville
OTHER
Responsible Party
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Lauren Hayes
Assistant Professor, Department of Pediatrics
Principal Investigators
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Lauren R Hayes, PhD
Role: PRINCIPAL_INVESTIGATOR
Norton Children's Medical Group, Affiliated with the University of Louisville School of Medicine
Locations
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UK DanceBlue Pediatric Hematology & Oncology
Lexington, Kentucky, United States
Kentucky Children's Hospital
Lexington, Kentucky, United States
Norton Children's Cancer Institute
Louisville, Kentucky, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
O'Donnell FT, Rosen KR. Pediatric pain management: a review. Mo Med. 2014 May-Jun;111(3):231-7.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Key Ingredients for Successful Trauma-Informed Care Implementation
Other Identifiers
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24.0284
Identifier Type: -
Identifier Source: org_study_id