Getting Recovery Right After Neck Dissection for Head and Neck Cancer (GRRAND)

RESEARCH QUESTION: What is the clinical and cost-effectiveness of a personalised, physiotherapy-led, rehabilitation intervention (the GRRAND programme) compared to best practice NHS, post-discharge care for adults undergoing neck dissection for head and neck cancer (HNC)?

BACKGROUND: Annually, HNCs are diagnosed in 700,000 people worldwide, with over 12,000 new cases in the UK. Surgical neck dissection is the most common component of treatment in both new cancers and those previously treated non-surgically but with residual neck disease. Side-effects from a neck dissection are debilitating and disabling and include neck and shoulder problems, difficulties sleeping, fatigue and anxiety.

These occur in 50-100% of patients. There is no robust evidence underpinning rehabilitation following neck dissection for HNC. It is not known if physiotherapy might improve this.

People with HNC are increasingly younger with higher occupational and social expectations post-treatment than previous generations. Determining the best recovery interventions for this population has major patient impact with health and social cost implications. A randomised controlled trial (RCT) is needed to determine if post-operative physiotherapy helps these patients.

DESIGN: Two-arm, multi-centre, pragmatic RCT with integrated health economics evaluation and process evaluation.

HEALTH TECHNOLOGIES: Personalised physiotherapist-led rehabilitation programme versus best practice NHS post-discharge care. TARGET POPULATION

INCLUSION CRITERIA: adults with HNC requiring primary neck dissection as part of their treatment with curative intent; able to attend a physiotherapy outpatient appointment.

EXCLUSION CRITERIA: people for whom intensive post-discharge physiotherapy is expected (i.e., scapula/scapula tip and/or latissimus dorsi free flaps); pre-existing, long-term neurological disease affecting the shoulder; previous neck dissection on the planned surgical side. OUTCOMES PRIMARY: The Shoulder Disability Index (SPADI), 12 months post-randomisation.

SECONDARY: (Baseline, six weeks, six- and 12-months post-randomisation): SPADI (except 12 months); individual SPADI domains; health-related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer (EORTC) cancer-specific questionnaires (C30(core) and Head & Neck 35(head and neck specific); Exercise Adherence Rating Scale; EQ-5D-5L and health resource use questionnaire (with additional three-month assessment); adverse events and post-operative complications.

SAMPLE SIZE: Total of 390 participants, to detect an eight-point difference in the SPADI score (90% power; 5% significance level, 25% loss to follow-up).

IMPACT & DISSEMINATION: The results will have an important impact on patients, as the best recovery approach following neck dissection for HNC is not known at present. Results will be presented in high-impact journals, HTA report and at conferences. With our PPIE members, we will produce lay summaries and disseminate through patient organisations, on websites and social media.

We will inform policy makers such as NICE. By delivering and disseminating a high-quality RCT, we will determine the best treatment for people trying to effectively recover from this disabling, under-researched problem. This will lead to improved guidance and treatment decision making, with a major impact on care in the UK and internationally for people after neck dissection for HNC.