SIP SMART: Swallowing Intervention package - Self Monitoring, Assessment & Rehabilitation Training
| ISRCTN | ISRCTN40215425 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40215425 |
| Protocol serial number | 17043 |
| Sponsor | University College London |
| Funder | NIHR (UK) |
- 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
 ORCID ID |
0000-0003-2249-434X |
|---|---|
| Roganie.Govender@uclh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional and Observational; Design type: Prevention, Process of Care, Treatment, Qualitative |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Swallowing related QOL is measured using the MD Anderson Dysphagia Inventory (MDADI) at baseline, 1, 3 and 6 months |
| Key secondary outcome measure(s) |
1. Health Related QOL is measured using FACT – QOL at baseline, 1, 3 and 6 months |
| Completion date | 30/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 45 |
| 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
- United Kingdom
- England
Study participating centre
First Floor East
250 Euston Road
London
NW1 2PQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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? |
|---|---|---|---|---|---|
| Results article | results | 29/04/2020 | 05/03/2021 | Yes | No |
| Protocol article | protocol | 27/03/2017 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
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.
