SIP SMART: Swallowing Intervention package - Self Monitoring, Assessment & Rehabilitation Training

ISRCTN	ISRCTN40215425
DOI	https://doi.org/10.1186/ISRCTN40215425
Secondary identifying numbers	17043

Submission date: 23/10/2014
Registration date: 23/10/2014
Last edited: 05/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-help-people-with-swallowing-after-treatment-for-head-and-neck-cancer

Contact information

Miss Roganie Govender
Scientific

Head & Neck Cancer Centre
Ground Floor Central
250 Euston Road
London
NW1 2PQ
United Kingdom

ORCID ID	0000-0003-2249-434X
Email	Roganie.Govender@uclh.nhs.uk

Study information

Study design	Randomised; Interventional and Observational; Design type: Prevention, Process of Care, Treatment, Qualitative
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Development and preliminary testing of a tailored pre-treatment swallowing intervention package for patients with head and neck cancer
Study acronym	SIP SMART
Study objectives	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(s)	NRES committee London- South East; 31/07/2014; ref. 14/LO/1152
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	29/01/2013
Completion date	30/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Interview study (13) feasibility trial (32)
Key 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
Key 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
Date of first enrolment	06/10/2014
Date of final enrolment	07/12/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London Hospital

Head & Neck Cancer Centre
First Floor East
250 Euston Road
London
NW1 2PQ
United Kingdom

Sponsor information

University College London
University/education

Joint Research Office
1st Floor, Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

Phone	+44 20 3447 5199
Email	david.wilson@ucl.ac.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

NIHR (UK)

No information available

Results and Publications

Intention to publish date	30/04/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Protocol article	protocol	27/03/2017		Yes	No
Results article	results	29/04/2020	05/03/2021	Yes	No
HRA research summary			26/07/2023	No	No

Editorial Notes

05/03/2021: Publication reference added.
19/02/2020: Cancer Research UK lay results summary link added to Results (plain English).
11/09/2018: The intention to publish date has been changed from 31/12/2017 to 30/04/2019.
10/09/2018: Publication reference added.
20/09/2016: The overall trial dates have been updated from 06/10/2014 - 01/09/2016 to 29/01/2013 - 30/08/2017 and the recruitment dates has been updated from 06/10/2014 - 01/09/2016 to 06/10/2014 - 07/12/2016. The recruitment for the interview phase takes place between 06/10/2014-16/12/2014 with a pause in recruitment before recruitment for the feasibility study commences on 05/04/2016 - 07/12/2016.
In addition, the IPD sharing statement has been added and the outcomes reformulated for clarity.
10/08/2016: Cancer Help UK lay summary link added.