The investigation of a co-produced nutritional prehabilitation intervention in head and neck cancer patients treated with radiotherapy (+/- chemotherapy)

Background: On diagnosis up to 60% of patients with head and neck cancer (HNC) are malnourished or at risk of malnutrition (1).

Treatment for HNC causes significant nutritional challenges due to the anatomical structures involved with eating and drinking that are the targets of multimodal treatment (5).

Prehabilitation provides the opportunity to mitigate against the malnutrition that is strongly associated with HNC and optimise patient self-management to support long term quality of life(QOL) throughout survivorship(34).

Research Question: How feasible is it to introduce a co-produced nutritional prehabilitation intervention within the head and neck cancer pathway for patients treated with radical radiotherapy (+/-chemotherapy).

Aim: To develop, implement and investigate the feasibility of a Co-produced nutritional prEhabilitation iN Head And Neck CancEr intervention for patients treated with radical radiotherapy (+/- chemotherapy) (Co- ENHANCE) Objectives: Identify challenges and potential solutions for delivering a nutritional prehabilitation intervention Co-produce a prototype personalised nutritional prehabilitation intervention (Co-ENHANCE) Determine eligibility, recruitment, adherence, compliance, and retention of patients to Co-ENHANCE Explore the mechanism of action of Co-ENHANCE using a behaviour change framework Evaluate HNC patients on the acceptability of the Co-ENHANCE intervention, study processes and integration to the pathway Test collection of nutritional, anthropometric and clinical outcome measures to inform acceptability Methods: This study development has followed the MRC framework for developing complex interventions through two work packages (47).

The first work package (WP1) will involve co-production using a Living Labs process with HNC patients, carers, professionals, and stakeholders to explore the challenges and potential solutions associated with nutritional prehabilitation. Together the co-creation group will co-create an innovative intervention.

This intervention will be called Co-ENHANCE. Work package two (WP2) will involve a single centre feasibility study.

This will recruit newly diagnosed patients being treated with radical radiotherapy +/- chemotherapy (CRT) and explore the implementation and mechanism of action of Co-ENHANCE through quantitative and qualitative data analysis.

The qualitative analysis will use semi structure interviews analysed using thematic analysis to evaluate the acceptability of the intervention and understand the mechanism of action using the COM-B framework. Timelines for delivery: WP 1 will be undertaken in year one and WP 2 within in years two to three.

Anticipated impact and dissemination: The robust collaborative development and feasibility testing of Co-ENHANCE will allow HNC teams nationwide to implement and/or adapt the intervention within their own services benefiting HNC receiving CRT nationally.

The Co-ENHANCE intervention protocol and results from feasibility testing including a logic model will display the mechanism of action using the COM-B framework.

This will be disseminated through published academic journal articles and shared at professional and patient centred conferences. Interactive infographics and animations will be used to deliver accessible information to reach a broach audience.

National HNC charities and patient and public representatives will be used to disseminate through online platforms and face to face.

Long term, Co-ENHANCE could be tested as part of an randomised control trial to assess effectiveness and combined with other prehabilitation interventions to create multimodal interventions.