Development and preliminary testing of a tailored pre-treatment swallowing intervention package for patients with head and neck cancer
Key Question: Does a tailored pre-treatment swallowing intervention package improve post treatment swallowing outcomes in head and neck cancer patients compared to current usual care?
To devise and define the swallowing intervention package.
To specify a protocol to test the intervention.
To undertake a feasibility study to gather salient information to inform a larger, more definitive trial.
NRES committee London- South East; 31/07/2014; ref. 14/LO/1152
Randomised; Interventional and Observational; Design type: Prevention, Process of Care, Treatment, Qualitative
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck
The study design is informed by the MRC complex intervention guidelines (Craig et. al, 2008)
The Development phase (intervention design) will be informed by literature reviews, in-depth patient interviews and paper modelling of the intervention.
The Preliminary testing phase - feasibility study using stratified block randomisation. 1:1 allocation to treatment or usual care group. Patients will be followed up for 6 months from date of surgery (if surgery only) or date of final radiotherapy treatment (if radiotherapy or combined modality treatment).
Primary outcome measures
1. Swallowing related QOL is measured using the MD Anderson Dysphagia Inventory (MDADI) at baseline, 1, 3 and 6 months
2. Swallowing physiology is measured using a modified barium swallow at 6 months
Secondary outcome measures
1. Health Related QOL is measured using FACT – QOL at baseline, 1, 3 and 6 months
2. Swallowing function and Normalcy of diet is measured using the Performance Status Scale (PSS) at baseline, 1, 3 and 6 months
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients who have completed treatment for advanced head and neck cancer
2. A minimum of 3 months post treatment
3. Had input from a SLT as part of their cancer care
4. Able to provide informed consent and willing to be interviewed for 40 minutes
5. Proficiency in English satisfactory for interview/participation in intervention
6. Aged 18 and above
Preliminary testing : feasibility study
1. Patients with newly diagnosed stage III and stage IV head and neck cancer
2. Discussed at the UCLH head and neck MDT and planned for curative treatment via surgery and/or chemoradiotherapy or combinations thereof
3. Able to provide informed consent
4. Proficiency in English satisfactory to participate/engage in the intervention
5. Aged 18 and above
Target number of participants
Interview study (13) feasibility trial (32)
Participant exclusion criteria
1. Patients who are mid treatment or those receiving palliation
2. Patients who have been treated solely by non standard treatment ie not surgery, radiotherapy, chemoradiotherapy or combinations thereof. Patients treated by chemotherapy, brachy therapy, photodynamic therapy alone will be ineligible.
3. Patients who are considered vulnerable or unable to provide informed consent
4. Patients with brain tumours and other primary sites not within head and neck
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University College London Hospital
Head & Neck Cancer Centre First Floor East 250 Euston Road
University College London
Joint Research Office
Maple House – Suite B
149 Tottenham Court Road
+44 20 3447 5199
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Manuscripts currently under review and further publication of results are planned over 2017 - 2018.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting