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Oncology
Protocol
A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer
  1. Anna M Sawka1,
  2. Sangeet Ghai2,
  3. George Tomlinson3,
  4. Lorne Rotstein4,
  5. Ralph Gilbert5,
  6. Patrick Gullane5,
  7. Jesse Pasternak4,
  8. Dale Brown5,
  9. John de Almeida5,
  10. Jonathan Irish5,
  11. Douglas Chepeha5,
  12. Kevin Higgins6,
  13. Eric Monteiro7,
  14. Jennifer M Jones8,
  15. Amiram Gafni9,
  16. David P Goldstein5
  1. 1 Department of Endocrinology, University Health Network, University of Toronto, Toronto, Ontario, Canada
  2. 2 Department of Radiology, University Health Network, University of Toronto, Toronto, Ontario, Canada
  3. 3 Department of Epidemiology and Biostatistics, University Health Network, University of Toronto, Toronto, Ontario, Canada
  4. 4 Department of Surgery, University Health Network, University of Toronto, Toronto, Ontario, Canada
  5. 5 Department of Otolaryngology, Head and Neck Surgery, University Health Network, University of Toronto, Toronto, Ontario, Canada
  6. 6 Department of Otolaryngology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
  7. 7 Department of Otolaryngology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
  8. 8 Department of Psychosocial Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada
  9. 9 Centre for Health Economics and Policy Analysis, McMaster University (HSC-3H29), Hamilton, Ontario, Canada
  1. Correspondence to Dr Anna M Sawka; sawkaam{at}yahoo.com

Abstract

Introduction Low-risk papillary thyroid cancer (PTC) is increasingly being diagnosed throughout the world; yet the mortality risk is low compared with other malignancies. Traditional management includes thyroid surgery, sometimes followed by radioactive iodine and thyroid hormone treatment. Active surveillance (AS) has been proposed as a means to reduce overtreatment of PTC. AS involves close disease follow-up, with the intention to intervene if the disease progresses, or on patient request.

Methods and analysis This is a multiphase prospective observational study. In the first phase of this study, consenting eligible adults with low-risk PTC, that is, <2 cm in maximal diameter, confined to the thyroid and not immediately adjacent to critical structures in the neck, are provided verbal and written information about PTC disease prognosis following surgery or AS. Questionnaires are administered at baseline and after the disease management decision on AS or surgery is finalised. Patients may choose either option (surgery or AS), and the primary outcome is the frequency with which either disease management option is chosen. Secondary outcomes include: rationale for the decision, role of the patient in decision-making and decision satisfaction. In the second phase of the study, consenting eligible adult patients who completed the first study phase may enrol in respective AS or surgery group follow-up studies. The following outcomes are examined 1 year after enrolment in the follow-up phase: decision regret about disease management choice (primary outcome), psychological distress, disease-specific quality of life, fear of disease progression, body image satisfaction, disease progression, crossover to surgery in the AS group, new chronic thyroid hormone use and healthcare resource utilisation.

Ethics and dissemination The University Health Network Research Ethics Board approved this study (ID 15-8942). The results will be published in an open access journal.

Trial registration number NCT03271892; Pre-results.

  • endocrine tumours

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-020298

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    Footnotes

    • Contributors The coprimary investigators, DPG and AMS designed the study, obtained funding for the study, oversaw all aspects of execution and reporting of the study. SG has provided input in study design and is the primary study radiologist, providing input on interpretation of ultrasound imaging of the neck. All of the surgeon investigators have provided input in study design, are active in assisting in participant recruitment for the study and provided input on this manuscript (LR, RG, PG, JP, DB, JdA, JI, DC, KH, EM). GT, JMJ and AG have provided input in methodological aspects of the study design and assisted in the application for study funding. GT is the statistician overseeing analysis of the study results. All authors have approved the final manuscript.

    • Funding Funding for the first phase of this study (medical decision-making) was obtained from an operating grant (Innovation Grant) from the Ontario Academic Health Sciences Centres Alternate Funding Plan Innovation Fund (Ontario Ministry of Health). The follow-up phase of the study (AMS and surgical arm follow-up to 1 year) is funded by an operating grant from the Canadian Cancer Society Research Institute (The Lotte and John Hecht Memorial Foundation Innovation Grant, #703948).

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval This study is approved by the University Health Network Research Ethics Board in Toronto, Canada.

    • Provenance and peer review Not commissioned; externally peer reviewed.