Topic: Cancer
Conditions
Interventions
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-dep
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Qualitative Interviews: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed