Contact information
Type
Scientific
Primary contact
Miss Roganie Govender
ORCID ID
http://orcid.org/0000-0003-2249-434X
Contact details
Head & Neck Cancer Centre
Ground Floor Central
250 Euston Road
London
NW1 2PQ
United Kingdom
-
Roganie.Govender@uclh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17043
Study information
Scientific title
Development and preliminary testing of a tailored pre-treatment swallowing intervention package for patients with head and neck cancer
Acronym
SIP SMART
Study hypothesis
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?
Preliminary work:
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.
Ethics approval
NRES committee London- South East; 31/07/2014; ref. 14/LO/1152
Study design
Randomised; Interventional and Observational; Design type: Prevention, Process of Care, Treatment, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck
Intervention
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).
Intervention type
Other
Phase
Not Applicable
Drug names
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
29/01/2013
Overall trial end date
30/08/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
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
06/10/2014
Recruitment end date
07/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospital
Head & Neck Cancer Centre
First Floor East
250 Euston Road
London
NW1 2PQ
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Joint Research Office
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 20 3447 5199
david.wilson@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
31/12/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary