Improved oral health in head and neck cancer survivors (OHHNC study): a study protocol for a multicentre two-armed randomised controlled trial.

چکیده اصلی

BACKGROUND: Head and neck cancer comprises a heterogeneous group of tumours affecting anatomical sites of the upper aerodigestive tract. Treatment often involves surgery and either radiotherapy or chemoradiotherapy. These treatments are associated with substantial morbidity and may have long-lasting adverse effects on oral health. Oral complications can negatively affect health-related quality of life, nutritional status, and social and work-related functioning. The aim is to evaluate an oral health care programme designed to prevent or mitigate late oral sequalae, and to assess its impact on health-related quality of life, oral health, work ability, nutritional status, healthcare-related economic costs, and psychological well-being. METHODS: This is a study protocol for a Swedish multicentre, two-armed, superiority randomised controlled trial that has been ethically approved by the Swedish Ethical Review Authority. Patient inclusion commenced in September 2025, with an intended sample of 300 participants. Adult patients (≥ 18 years) planned for curative-intent treatment for head and neck cancer (oral cavity, oropharynx, larynx stage III and IV, hypopharynx, nasopharynx, salivary gland, or unknown primary) are randomised (1:1) to either an oral health care programme (intervention) or standard of care. EXCLUSION CRITERIA: severe alcoholism, cognitive impairment, or inability to understand the Swedish language. Participants are followed before the start of cancer treatment and at 4 follow-ups: 6 months after completion of treatment, and 1, 2, and 3 years after the 6-month follow-up. The primary outcome measure is health-related quality of life. Secondary outcomes include quantitative oral health indicators, return to work, nutritional status, healthcare-related economic costs, and patient-reported outcome measures focusing on self-reported oral health and psychological well-being (depression, anxiety and stress), and self-efficacy. DISCUSSION: Oral health follow-up for head and neck cancer survivors often lacks consistency and uniformity. To date, few oral health care interventions for head and neck cancer survivors have been evaluated within the framework of a randomised controlled trial. The findings have the potential to inform clinical practice and contribute to the development of more integrated, evidence-based oral healthcare strategies within routine follow-up for head and neck cancer survivors, with the overarching goal of improving their oral health and long-term quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT07173270, date 15/9/2025.

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