Head and neck cancer Cancer
Conditions
Interventions
Standard care group: Patients recruited at sites randomised to usual care will receive the standard of care offered by the SLT service prior to their upcoming cancer treatment. Usual care may include
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults over the age of 18 years. 2. Both males and females. 3. Clinical and Radiological diagnosis of new stage III/IV tumour of the head and neck (oral cavity, oropharynx, nasopharynx, hypopharynx, mandible, maxilla, unknown primary with planned bilateral neck radiation) 4. Discussed at the multidisciplinary team (MDT) meeting and planned for treatment with curative intent via surgery, radiotherapy, chemoradiotherapy or combinations thereof. 5. Able to provide informed consent. 6. Patients who do not have English as their first language but for whom appropriate translation services as per local hospital practice is in place.
Exclusion criteria
Exclusion criteria: 1. Patients with a previous diagnosis of head and neck cancer. 2. Patients who have not consented prior to cancer treatment, or those receiving palliation. 3. Patients who are to be treated solely by non-standard treatment such as photodynamic therapy, brachytherapy or chemotherapy alone. 4. Patients who are planned for a total laryngectomy or long-term tracheostomy. 5. Patients who are vulnerable and/or have significant co-morbidities as determined by the clinical team and/or with a score of 4 on the WHO performance status scale. 6. Patients who have long-term medical history of neurological conditions resulting in known pre-existing dysphagia. 7. Patients with brain tumours and other primary sites not within head and neck. 8. Patients who are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment/retention will be measured by: 1. Proportion of hospitals invited who agree to participate in the RCT (test of sampling, recruitment and retention approaches for hospital sites) – pre-trial logs. 2. Proportion of people with head and neck cancer approached in both trial arms who agree to provide outcome data for research evaluation – based on screening logs. 3. The proportion of patients in the intervention and control groups for whom it is possible to collect follow-up data to the point of assessing the primary outcome (clinical effectiveness as determined by the MDADI score) and data relevant for an economic evaluation (cost effectiveness) – data completeness at 6-month follow-up. 4. Proportion of missing data on each outcome at all data points measured in both arms – data completeness at baseline, one month, three months and six month time-points. 5. Proportion of patients who report satisfactory adherence to the intervention as measured by a study customised adherence questionnaire at one, three and 6 months. 6. Acceptability will be assessed via process evaluation of factors related to context and implementation at pre-trial, during trial and post-trial that may impact the future main trial. This will involve focus group discussions and one-to-one interviews with patients and staff. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dysphagia related QOL will be measured by the MDADI at baseline, one, three and six months. 2. Clinical assessment of swallow function will be measured using the water swallow test, maximal inter-incisor jaw opening and the head and neck performance status scale for normalcy of diet and public eating at baseline, one, three and six months. 3. Health related quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT_HN) at baseline, one, three and six months. 4. Change in nutritional parameters including weight and feeding tube status at baseline, one, three and six months will also provide proxy indicators for swallowing function. Economic outcomes: 5. Costs associated with the intervention and usual care using NHS treatment tariffs 6. Health care utilisation costs, time and travel and productivity losses using the UK Cancer costs Questionnaire (UKCC - Version3) 7. Incremental cost per change in MDADI score between 1 month post treatment and 6 months. | — |
Countries
United Kingdom
Outcome results
None listed