Acupressure for Children in Treatment for a Childhood Cancer

NCT03313193 | Completed DMC

• 1 other identifier: 170820
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT. Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for \~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B). Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.

Conditions

Treatment-Related Cancer

Keywords

nausea; vomiting; pain; fatigue; depression; anxiety; PTSD-parent; caregiver self efficacy-parent

Outcome Measures

Primary Outcomes (1)

• Decrease in nausea/vomiting severity

  assessed using the Pediatric Nausea Assessment Tool (PeNAT)(Dupuis, 2006)(see description below) + a single Question on vomiting for ages 5-17. The MASCC Anti-emesis Tool (MAT) will be used to assess nausea (yes/no) and severity for ages 18+.This composite measure of nausea/vomiting in the child represents a continuum of nausea/vomiting (range=1-8).

  past 24 hours for nausea/vomiting measures daily over 30 days of hospital-based treatment (continuous hospitalization or intermittent treatment over 2 months)

Secondary Outcomes (16)

• Decreased nausea (PeNAT)

  30 days hospital-based treatment (continuous or intermittent over 2 months)

• Decreased vomiting (Vol, 2016)

  30 days hospitalization (continuous or intermittent over 2 months)

• Use of fewer rescue anti-emetics (from Electronic Medical Records)

  30 days hospital-based treatment (continuous or intermittent over 2 months)

• Complete control of nausea/vomiting

  30 days hospital-based treatment (continuous or intermittent over 2 months)

• Decreased pain interference assessed using the PROMIS Pediatric Pain Interference Scale

  30 days hospital-based treatment (continuous or intermittent over 2 months)

Study Arms (2)

Arm A

EXPERIMENTAL

Acupressure for Children in Treatment for a Childhood Cancer + usual care

Other: Acupressure for Children in Treatment for a Childhood Cancer

Arm B

NO INTERVENTION

Usual care alone

Interventions

Acupressure for Children in Treatment for a Childhood Cancer OTHER

This study will describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. Children in Arm A will receive usual symptom management care + acupressure 5 days/week for \~20 treatments. Parents will be taught how to provide acupressure as well. Children in Arm B will receive usual care alone.

Arm A

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children who are either receiving treatment for diagnosis of a childhood cancer (curative or supportive care) or are receiving a chemotherapy-based HSCT. Non-malignant brain central nervous system tumors are considered as a childhood cancer.
• Ages 5- 24 years old.
• Be receiving hospital-based treatment (inpatient or outpatient) so that acupressure treatments can be delivered and parents can be trained and monitored.
• Availability and willingness of a parent or caregiver to deliver acupressure for ages 5-17. For young adults ages 18-24 participation of a parent, close friend or family member/caregiver is preferred but not required.
• English or Spanish speaking.
• Receiving treatment at UCSF Benioff Children's Hospital.

You may not qualify if:

• \) Children/young adults who meet the above criteria, but whose treating oncologist, health care provider, or a study investigator advises against study participation for physical health, mental health (parent or child) or logistical reasons.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Pierre's Birthday Fund: collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (23)

• Roscoe JA, Morrow GR, Hickok JT, Bushunow P, Pierce HI, Flynn PJ, Kirshner JJ, Moore DF, Atkins JN. The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting. A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. J Pain Symptom Manage. 2003 Aug;26(2):731-42. doi: 10.1016/s0885-3924(03)00254-9.

  PMID: 12906958 BACKGROUND

• Mao JJ, Xie SX, Bowman MA. Uncovering the expectancy effect: the validation of the acupuncture expectancy scale. Altern Ther Health Med. 2010 Nov-Dec;16(6):22-7.

  PMID: 21280459 BACKGROUND

• Forrest CB, Bevans KB, Tucker C, Riley AW, Ravens-Sieberer U, Gardner W, Pajer K. Commentary: the patient-reported outcome measurement information system (PROMIS(R)) for children and youth: application to pediatric psychology. J Pediatr Psychol. 2012 Jul;37(6):614-21. doi: 10.1093/jpepsy/jss038. Epub 2012 Feb 23. No abstract available.

  PMID: 22362923 BACKGROUND

• Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341.

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• DeWitt EM, Stucky BD, Thissen D, Irwin DE, Langer M, Varni JW, Lai JS, Yeatts KB, Dewalt DA. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. doi: 10.1016/j.jclinepi.2010.10.012. Epub 2011 Feb 2.

  PMID: 21292444 BACKGROUND

• Irwin DE, Stucky B, Langer MM, Thissen D, Dewitt EM, Lai JS, Varni JW, Yeatts K, DeWalt DA. An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Qual Life Res. 2010 May;19(4):595-607. doi: 10.1007/s11136-010-9619-3. Epub 2010 Mar 7.

  PMID: 20213516 BACKGROUND

• Varni JW, Stucky BD, Thissen D, Dewitt EM, Irwin DE, Lai JS, Yeatts K, Dewalt DA. PROMIS Pediatric Pain Interference Scale: an item response theory analysis of the pediatric pain item bank. J Pain. 2010 Nov;11(11):1109-19. doi: 10.1016/j.jpain.2010.02.005. Epub 2010 Jun 2.

  PMID: 20627819 BACKGROUND

• Kashikar-Zuck S, Carle A, Barnett K, Goldschneider KR, Sherry DD, Mara CA, Cunningham N, Farrell J, Tress J, DeWitt EM. Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain. Pain. 2016 Feb;157(2):339-347. doi: 10.1097/j.pain.0000000000000378.

  PMID: 26447704 BACKGROUND

• Varni JW, Thissen D, Stucky BD, Liu Y, Gorder H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, DeWalt DA. PROMIS(R) Parent Proxy Report Scales: an item response theory analysis of the parent proxy report item banks. Qual Life Res. 2012 Sep;21(7):1223-40. doi: 10.1007/s11136-011-0025-2. Epub 2011 Oct 5.

  PMID: 21971875 BACKGROUND

• Irwin DE, Gross HE, Stucky BD, Thissen D, DeWitt EM, Lai JS, Amtmann D, Khastou L, Varni JW, DeWalt DA. Development of six PROMIS pediatrics proxy-report item banks. Health Qual Life Outcomes. 2012 Feb 22;10:22. doi: 10.1186/1477-7525-10-22.

  PMID: 22357192 BACKGROUND

• Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.

  PMID: 22829446 BACKGROUND

• Lai JS, Stucky BD, Thissen D, Varni JW, DeWitt EM, Irwin DE, Yeatts KB, DeWalt DA. Development and psychometric properties of the PROMIS((R)) pediatric fatigue item banks. Qual Life Res. 2013 Nov;22(9):2417-27. doi: 10.1007/s11136-013-0357-1. Epub 2013 Feb 2.

  PMID: 23378106 BACKGROUND

• Vol H, Flank J, Lavoratore SR, Nathan PC, Taylor T, Zelunka E, Maloney AM, Lee Dupuis L. Poor chemotherapy-induced nausea and vomiting control in children receiving intermediate or high dose methotrexate. Support Care Cancer. 2016 Mar;24(3):1365-71. doi: 10.1007/s00520-015-2924-1. Epub 2015 Sep 3.

  PMID: 26335406 BACKGROUND

• Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592/phco.26.9.1221.

  PMID: 16945043 BACKGROUND

• Dupuis LL. Chemotherapy-induced vomiting in children: some progress, more questions. Lancet Oncol. 2016 Mar;17(3):264-265. doi: 10.1016/S1470-2045(15)00582-3. Epub 2016 Jan 19. No abstract available.

  PMID: 26795845 BACKGROUND

• Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9.

  PMID: 2367140 BACKGROUND

• Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.

  PMID: 16777328 BACKGROUND

• Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.

  PMID: 20921070 BACKGROUND

• Tsze DS, Hirschfeld G, von Baeyer CL, Bulloch B, Dayan PS. Clinically significant differences in acute pain measured on self-report pain scales in children. Acad Emerg Med. 2015 Apr;22(4):415-22. doi: 10.1111/acem.12620. Epub 2015 Mar 13.

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• Powell CV, Kelly AM, Williams A. Determining the minimum clinically significant difference in visual analog pain score for children. Ann Emerg Med. 2001 Jan;37(1):28-31. doi: 10.1067/mem.2001.111517.

  PMID: 11145767 BACKGROUND

• O'Sullivan C, Dupuis LL, Gibson P, Johnston DL, Baggott C, Portwine C, Spiegler B, Kuczynski S, Tomlinson D, de Mol Van Otterloo S, Tomlinson GA, Sung L. Refinement of the symptom screening in pediatrics tool (SSPedi). Br J Cancer. 2014 Sep 23;111(7):1262-8. doi: 10.1038/bjc.2014.445. Epub 2014 Aug 7.

  PMID: 25101569 BACKGROUND

• Tomlinson D, Dupuis LL, Gibson P, Johnston DL, Portwine C, Baggott C, Zupanec S, Watson J, Spiegler B, Kuczynski S, Macartney G, Sung L. Initial development of the Symptom Screening in Pediatrics Tool (SSPedi). Support Care Cancer. 2014 Jan;22(1):71-5. doi: 10.1007/s00520-013-1945-x. Epub 2013 Aug 31.

  PMID: 23995756 BACKGROUND

• Molassiotis A, Russell W, Hughes J, Breckons M, Lloyd-Williams M, Richardson J, Hulme C, Brearley S, Campbell M, Garrow A, Ryder W. The effectiveness and cost-effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea: Assessment of Nausea in Chemotherapy Research (ANCHoR), a randomised controlled trial. Health Technol Assess. 2013 Jun;17(26):1-114. doi: 10.3310/hta17260.

  PMID: 23803562 BACKGROUND

MeSH Terms

Conditions

Neoplasms, Second Primary; Nausea; Vomiting; Pain; Fatigue; Depression; Anxiety Disorders

Interventions

Acupressure; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Officials

• Anne Lown, Dr.P.H.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: E. Anne Lown, Dr.P.H., Associate Adjunct Professor

Model Details: Pragmatic Randomized Controlled Trial

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: October 18, 2017
• Study Start: September 26, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

US (1)