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Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer.

Publication ,  Journal Article
Reeve, BB; McFatrich, M; Pinheiro, LC; Freyer, DR; Basch, EM; Baker, JN; Withycombe, JS; Sung, L; Mack, JW; Waldron, MK; Mowbray, C; Palma, D ...
Published in: J Pain Symptom Manage
April 2017

CONTEXT: The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. OBJECTIVES: This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. METHODS: From seven pediatric cancer hospitals, 51 adolescents (13-20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive interviews with retrospective probing were completed in age groups of 13-15 and 16-20 year olds. Proxies were interviewed independently. RESULTS: In general, the 16-20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13-15 year olds had greater challenges completing the PRO-CTCAE. CONCLUSION: This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.

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Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

April 2017

Volume

53

Issue

4

Start / End Page

759 / 766

Location

United States

Related Subject Headings

  • Young Adult
  • United States
  • Terminology as Topic
  • Retrospective Studies
  • Proxy
  • Patient Reported Outcome Measures
  • Parents
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Male
 

Citation

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Reeve, B. B., McFatrich, M., Pinheiro, L. C., Freyer, D. R., Basch, E. M., Baker, J. N., … Hinds, P. S. (2017). Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. J Pain Symptom Manage, 53(4), 759–766. https://doi.org/10.1016/j.jpainsymman.2016.11.006
Reeve, Bryce B., Molly McFatrich, Laura C. Pinheiro, David R. Freyer, Ethan M. Basch, Justin N. Baker, Janice S. Withycombe, et al. “Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer.J Pain Symptom Manage 53, no. 4 (April 2017): 759–66. https://doi.org/10.1016/j.jpainsymman.2016.11.006.
Reeve BB, McFatrich M, Pinheiro LC, Freyer DR, Basch EM, Baker JN, et al. Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. J Pain Symptom Manage. 2017 Apr;53(4):759–66.
Reeve, Bryce B., et al. “Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer.J Pain Symptom Manage, vol. 53, no. 4, Apr. 2017, pp. 759–66. Pubmed, doi:10.1016/j.jpainsymman.2016.11.006.
Reeve BB, McFatrich M, Pinheiro LC, Freyer DR, Basch EM, Baker JN, Withycombe JS, Sung L, Mack JW, Waldron MK, Mowbray C, Palma D, Hinds PS. Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. J Pain Symptom Manage. 2017 Apr;53(4):759–766.
Journal cover image

Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

April 2017

Volume

53

Issue

4

Start / End Page

759 / 766

Location

United States

Related Subject Headings

  • Young Adult
  • United States
  • Terminology as Topic
  • Retrospective Studies
  • Proxy
  • Patient Reported Outcome Measures
  • Parents
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Male