SIP SMART: Swallowing Intervention package - Self Monitoring, Assessment & Rehabilitation Training
ISRCTN | ISRCTN40215425 |
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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
Plain English summary of protocol
Contact information
Scientific
Head & Neck Cancer Centre
Ground Floor Central
250 Euston Road
London
NW1 2PQ
United Kingdom
0000-0003-2249-434X | |
Roganie.Govender@uclh.nhs.uk |
Study information
Study design | Randomised; Interventional and Observational; Design type: Prevention, Process of Care, Treatment, Qualitative |
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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 |
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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
First Floor East
250 Euston Road
London
NW1 2PQ
United Kingdom
Sponsor information
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 |
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david.wilson@ucl.ac.uk | |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
No information available
Results and Publications
Intention to publish date | 30/04/2019 |
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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.