SIP SMART 2 - Prehabilitation of Swallowing
Research type
Research Study
Full title
Prehabilitation of swallowing difficulties in people with head and neck cancer: A pilot cluster randomised trial and process evaluation
IRAS ID
305731
Contact name
Roganie Govender
Contact email
Sponsor organisation
UCL
ISRCTN Number
ISRCTN12377415
Clinicaltrials.gov Identifier
Data Protection office reference, Z6364106 20220179
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
People with cancer in the mouth or throat (head and neck cancer) usually have difficulty in swallowing food and drink at some stage before, during and/or after cancer treatment. Dysphagia (difficulty in swallowing) may persist for months or years after treatment due to side-effects of surgery and chemo/radiotherapy.
The aim of this research is to determine whether a pre-treatment swallowing intervention package improves patients’ ability to eat and drink thus increasing their quality of life. The SIP SMART prehabilitation intervention comprises multiple components including: tailored information, educational counseling, personalized exercises, and specific strategies to help engage with advice and exercises.This is a pilot study in which a small-scale version of the anticipated large clinical trial will be tested at six NHS hospitals randomised into two groups. Patients newly diagnosed with head and neck cancer will be approached to take part. Participation will not affect cancer treatment. One group will receive the routine “usual care” which involves meeting with the speech and language therapist (SLT) for general advice and provision of a generic swallowing exercises leaflet. The intervention group will receive the new prehabilitation package incorporating the components mentioned above. The SLTs at the intervention hospitals will all receive training in the prehabilitation package. This pilot study will provide important information about whether hospitals can recruit a sufficient number of patients to the trial, and about whether patients remain in the study long enough (six months after completion of treatment) to collect all necessary outcome measures. Other factors that may affect results in a large trial will also be explored. This includes whether SLTs deliver the intervention as planned and what patients feel about the intervention and their engagement with it. This pilot is funded by the NIHR and is important in securing further funding for a larger trial.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0150
Date of REC Opinion
1 Mar 2022
REC opinion
Favourable Opinion