Introduction Advanced oral cancer and its ensuing treatment engenders significant morbidity and mortality. Patients are often elderly with significant comorbidities. Toxicities associated with surgical resection can be devastating and they are often highlighted by patients as impactful. Given the potential for suboptimal oncological and functional outcomes in this vulnerable patient population, promotion and performance of shared decision making (SDM) is crucial.
Decision aids (DAs) are useful instruments for facilitating the SDM process by presenting patients with up-to-date evidence regarding risks, benefits and the possible postoperative course. Importantly, DAs also help elicit and clarify patient values and preferences. The use of DAs in cancer treatment has been shown to reduce decisional conflict and increase SDM. No DAs for oral cavity cancer have yet been developed.
This study endeavours to answer the question: Is there a patient or surgeon driven need for development and implementation of a DA for adult patients considering major surgery for oral cancer?
Methods and analysis This study is the first step in a multiphase investigation of SDM during major head and neck surgery. It is a multi-institutional convergent parallel mixed-methods needs assessment study. Patients and surgeon dyads will be recruited to complete questionnaires related to their perception of the SDM process (nine-item Shared Decision-Making Questionnaire, SDM-Q-9 and SDM-Q-Doc) and to take part in semistructured interviews. Patients will also complete questionnaires examining decisional self-efficacy (Ottawa Decision Self-Efficacy Scale) and decisional conflict (Decisional Conflict Scale). Questionnaires will be completed at time of recruitment and will be used to assess the current level of SDM, self-efficacy and conflict in this setting. Thematic analysis will be used to analyse transcripts of interviews. Quantitative and qualitative components of the study will be integrated through triangulation, with matrix developed to promote visualisation of the data.
Ethics and Dissemination This study has been approved by the research ethics boards of the Nova Scotia Health Authority (Halifax, Nova Scotia) and the University Health Network (Toronto, Ontario). Dissemination to clinicians will be through traditional approaches and creation of a head and neck cancer SDM website. Dissemination to patients will include a section within the website, patient advocacy groups and postings within clinical environments.
- shared decision-making
- oral cancer
- decision aid
- needs assessment
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Collaborators The authors have no competing financial interests. Intellectual disclaimers include: PH, DF, and AGS perform research in shared decision-making in otolaryngology – head & neck surgery. JdA, DG, MC, JCI, RG, JRT, SMT, MHR, PJG, DHB, and AGS are practicing head and neck surgical oncologists and treat patients with advanced oral cavity cancer. DF is a resident physician involved in the care of patients undergoing major head and neck surgery. RM is a speech-language pathologist specialising in the treatment of dysphagia in head and neck cancer patients. AMS is an endocrinologist with previous experience in shared decision-making and decision aid development for thyroid nodules. VER is a scientist and conducts mixed-methods studies in health technology assessment and health services research. DG conducts research promoting outcomes in elderly patients undergoing major head and neck surgery.
Contributors DF, MC and DG planned the study, developed the initial protocol, and revised protocol versions. PH, AS and AMS offered expert advice on shared decision making and protocol design. VER, JdA and RM offered expert advice on qualitative research and mixed-method study design. PH and VER offered expert advice on needs assessment protocol development. JCI, RG, JRT, SMT, MHR, PG, DB and DHB offered expert advice on the surgical management of oral cancer. RM, JdA and JR offered expert advice on quality of life research. All authors read and approved the final protocol and corresponding manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement statement Patient and public involvement in the design of this study was not elicited. Subsequent phases in the overarching study may include key patient and public stakeholders.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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