The SHARE study – Survivorship After Head and Neck Cancer: evaluating patient care and adherence to follow up in Ontario, Canada: study protocol for a randomized controlled trial

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BACKGROUND: Survivors of head and neck cancer (HNC) experience long-term physical and psychosocial effects post-treatment, however, often receive fragmented survivorship care. Evidence-based survivorship guidelines exist, but implementation remains limited. Poor coordination, insufficient communication, and lack of tailored support contribute to unmet patient needs. Treatment Summary and Survivorship Care Plans (TSSP) and Motivational Interviewing (MI) may improve self-efficacy and adherence to survivorship care recommendations. This study aims to evaluate whether a personalized TSSP along with a one-time MI counselling session improves physician implementation of survivorship care recommendations, patient satisfaction with post-treatment care, and quality of life (QoL) among HNC survivors. METHODS/DESIGN: This study is a prospective, single-centre, two-arm, superiority randomized controlled trial (RCT) with a 1:1 allocation ratio. Outcomes will be evaluated at baseline, 3, 6, and 12 months post-baseline visit. A total of 252 HNC survivors (stage I-IVA, aged ≥ 18 years, 3-6 months post-definitive treatment, English-speaking, with no metastatic or residual disease) will be recruited by a trained research assistant through the Survivorship Clinic at Victoria Hospital in London, Canada. Recruitment began in May 2025. Participants will be randomized to either the intervention group (TSSP and MI session) or the control group (usual care only). The intervention consists of a 45-min MI session delivered by a trained nurse practitioner, focused on exploring the top 3 patient survivorship symptoms/concerns, providing resources and referrals, and goal-setting related to survivorship care recommendations. The primary outcome is the proportion of patient-identified survivorship symptoms/concerns addressed by primary care providers (PCP) at 12 months post-baseline between study groups, with secondary assessments at 3 and 6 months. Secondary outcomes include patient satisfaction with the TSSP and MI session, patient satisfaction with care and information, QoL, and PCP feedback on the utility of the TSSP. Descriptive statistics will be reported, and intention-to-treat analyses will be conducted using mixed-effects models to evaluate group differences over time. DISCUSSION: This study will contribute new evidence on the feasibility and effectiveness of integrating a scalable, combined TSSP and MI counselling intervention into routine HNC survivorship care. By promoting patient-centered communication, this approach may empower survivors to engage in self-management and improve long-term health outcomes. Findings will inform best practices for survivorship care planning and support the implementation of patient-tailored interventions across various oncology settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT06127784. Registered on Nov. 6, 2023; https://www. CLINICALTRIALS: gov/study/NCT06127784 .

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