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Feasibility of a randomized controlled trial of symptom screening and feedback to healthcare providers compared with standard of care using the SPARK platform

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Supportive Care in Cancer Aims and scope Submit manuscript

Abstract

Purpose

Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application that enables symptom screening and access to clinical practice guidelines for symptom management. Objective was to determine the feasibility of a randomized trial of daily symptom screening for 5 days among children receiving cancer treatments.

Methods

We included English-speaking pediatric cancer and hematopoietic stem cell transplantation (HSCT) patients who were 8–18 years of age at enrollment and who were expected to be in the hospital or in clinic daily for five consecutive days. We randomized children to either undergo daily symptom screening with symptom reports provided to the healthcare team using the SPARK vs. standard of care. The primary endpoint was feasibility, defined as being able to enroll at least 30 participants within 1 year, and among those randomized to intervention, at least 75% completing symptom screening on at least 60% of on-study days.

Results

From July 2018 to November 2018, we enrolled and randomized 30 participants. The median age at enrollment was 12.5 (range 8–18) years. Among the intervention group, the median number of days Symptom Screening in Pediatrics Tool (SSPedi) was completed at least once was 5 (range 4 to 5), with one participant missing 1 day of symptom screening. Among all participants, baseline and day 5 SSPedi scores were obtained in 29/30 participants.

Conclusion

A randomized trial of the SPARK with daily symptom screening for 5 days was feasible. It is now appropriate to proceed toward a definitive multi-center trial to test the efficacy of SPARK to improve symptom control.

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References

  1. Johnston DL, Hyslop S, Tomlinson D, Baggott C, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Dupuis LL, Sung L (2018) Describing symptoms using the Symptom Screening in Pediatrics Tool in hospitalized children with cancer and hematopoietic stem cell transplant recipients. Cancer Med 7(5):1750–1755

    Article  Google Scholar 

  2. Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P et al (2018) Validation of the Symptom Screening in Pediatrics Tool in children receiving cancer treatments. J Natl Cancer Inst

  3. Hyslop S, Davis H, Duong N, Loves R, Schechter T, Tomlinson D et al (2019) Symptom documentation and intervention provision for symptom control in children receiving cancer treatments. Eur J Cancer 109:120–128

    Article  Google Scholar 

  4. 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 (2014) Refinement of the Symptom Screening in Pediatrics Tool (SSPedi). BJC 111(7):1262–1268

    Article  Google Scholar 

  5. O’Sullivan C, Dupuis L, Gibson P, Johnston DL, Baggott C, Portwine C et al (2018) Evaluation of the electronic self-report Symptom Screening in Pediatrics Tool (SSPedi). BMJ Support Palliat Care 8(1):110–116

    Article  Google Scholar 

  6. Cook S, Vettese E, Soman D, Hyslop S, Kuczynski S, Spiegler B, Davis H, Duong N, Ou Wai S, Golabek R, Golabek P, Antoszek-Rallo A, Schechter T, Lee Dupuis L, Sung L (2019) Initial development of Supportive care Assessment, Prioritization and Recommendations for Kids (SPARK), a symptom screening and management application. BMC Med Inform Decis Mak 19(1):9

    Article  Google Scholar 

  7. Moore CG, Carter RE, Nietert PJ, Stewart PW (2011) Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci 4(5):332–337

    Article  Google Scholar 

  8. Von Baeyer CL, Hicks CL (2000) Support for a common metric for pediatric pain intensity scales. Pediatr Pain Manag 5(2):157–160

    Google Scholar 

  9. Tomlinson D, von Baeyer CL, Stinson JN, Sung L (2010) A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics 126(5):e1168–e1198

    Article  Google Scholar 

  10. Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P (2002) The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer 94(7):2090–2106

    Article  Google Scholar 

  11. Varni JW, Katz ER, Seid M, Quiggins DJ, Friedman-Bender A (1998) The pediatric cancer quality of life inventory-32 (PCQL-32): I. reliability and validity. Cancer 82(6):1184–1196

    Article  CAS  Google Scholar 

  12. Varni JW, Rode CA, Seid M, Katz ER, Friedman-Bender A, Quiggins DJ (1999) The Pediatric Cancer Quality of Life Inventory-32 (PCQL-32). II. Feasibility and range of measurement. J Behav Med 22(4):397–406

    Article  CAS  Google Scholar 

  13. Varni JW, Seid M, Kurtin PS (2001) PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care 39(8):800–812

    Article  CAS  Google Scholar 

  14. Basch E, Dueck AC, Rogak LJ, Mitchell SA, Minasian LM, Denicoff AM et al (2018) Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial: NCCTG N1048. J Clin Oncol JCO2018788620

  15. Basch E, Dueck AC, Rogak LJ, Minasian LM, Kelly WK, O’Mara AM, Denicoff AM, Seisler D, Atherton PJ, Paskett E, Carey L, Dickler M, Heist RS, Himelstein A, Rugo HS, Sikov WM, Socinski MA, Venook AP, Weckstein DJ, Lake DE, Biggs DD, Freedman RA, Kuzma C, Kirshner JJ, Schrag D (2017) Feasibility assessment of patient reporting of symptomatic adverse events in multicenter cancer clinical trials. JAMA Oncol 3(8):1043–1050

    Article  Google Scholar 

  16. Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D (2016) Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 34(6):557–565

    Article  CAS  Google Scholar 

  17. Li M, Macedo A, Crawford S, Bagha S, Leung YW, Zimmermann C et al (2016) Easier said than done: keys to successful implementation of the Distress Assessment and Response Tool (DART) Program. J Oncol Pract 12(5):e513–e526

    Article  Google Scholar 

  18. Tran K, Zomer S, Chadder J, Earle C, Fung S, Liu J, Louzado C, Rahal R, Moxam RS, Green E (2018) Measuring patient-reported outcomes to improve cancer care in Canada: an analysis of provincial survey data. Curr Oncol 25(2):176–179

    Article  CAS  Google Scholar 

  19. O’Sullivan C, Dupuis LL, Sung L (2015) A review of symptom screening tools in pediatric cancer patients. Curr Opin Oncol 27(4):285–290

    Article  Google Scholar 

  20. Dupuis LL, Ethier MC, Tomlinson D, Hesser T, Sung L (2012) A systematic review of symptom assessment scales in children with cancer. BMC Cancer 12:430

    Article  Google Scholar 

  21. Dussel V, Orellana L, Soto N, Chen K, Ullrich C, Kang TI, Geyer JR, Feudtner C, Wolfe J (2015) Feasibility of conducting a palliative care randomized controlled trial in children with advanced cancer: assessment of the PediQUEST Study. J Pain Symptom Manag 49(6):1059–1069

    Article  Google Scholar 

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Funding

This research is funded by Canadian Institutes of Health Research (CIHR) catalyst grant (funding number 155446). LS is supported by the Canada Research Chair in Pediatric Oncology Supportive Care.

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Authors and Affiliations

  1. Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada

    Sadie Cook, Emily Vettese & Lillian Sung

  2. Department of Medicine, Toronto General Hospital, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada

    George A. Tomlinson

  3. Rotman School of Management, University of Toronto, 105 St. George Street, Toronto, Ontario, M5S 3E6, Canada

    Dilip Soman

  4. Division of Haematology/Oncology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada

    Tal Schechter & Lillian Sung

  5. Ontario Parents Advocating for Children with Cancer (OPACC), 99 Citation Drive, Toronto, Ontario, M2K 1S9, Canada

    Susan Kuczynski

  6. Dalla Lana School of Public Health, University of Toronto, 105 St. George Street, Toronto, Ontario, M5S 3E6, Canada

    Brenda Gladstone

  7. Department of Pharmacy, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada

    L. Lee Dupuis

Authors
  1. Sadie Cook
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  2. Emily Vettese
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  3. George A. Tomlinson
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  4. Dilip Soman
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  5. Tal Schechter
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  6. Susan Kuczynski
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  7. Brenda Gladstone
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  8. L. Lee Dupuis
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  9. Lillian Sung
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Sadie Cook, Emily Vettese, and Lillian Sung. The first draft of the manuscript was written by Sadie Cook, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Lillian Sung.

Ethics declarations

Informed consent was obtained from all individual participants included in the study. The authors have declared no conflicts of interest.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Research Ethics Board at SickKids, and are registered with clinicaltrial.gov (NCT03495518), and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Sadie Cook and Emily Vettese are co-first authors.

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Cook, S., Vettese, E., Tomlinson, G.A. et al. Feasibility of a randomized controlled trial of symptom screening and feedback to healthcare providers compared with standard of care using the SPARK platform. Support Care Cancer 28, 2729–2734 (2020). https://doi.org/10.1007/s00520-019-05115-2

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  • DOI: https://doi.org/10.1007/s00520-019-05115-2

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