Condition category
Cancer
Date applied
23/10/2014
Date assigned
23/10/2014
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

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.