Dataset Information

SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer.

ABSTRACT:

Background

Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART - [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation.

Methods

This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online web-based system. SIP SMART comprised two 45-min consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing.

Results

A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation.

Conclusions

A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS.

Trial registration

ISRCTN40215425, registered retrospectively.

SUBMITTER: Govender R

PROVIDER: S-EPMC7191731 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer.

Govender Roganie R Smith Christina H CH Barratt Helen H Gardner Benjamin B Taylor Stuart A SA

BMC cancer 20200429 1

<h4>Background</h4>Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART - [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to i ...[more]

PMID: 32349693

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Project description:IntroductionOn commencing internship, new medical graduates (new interns) are often required to perform core procedural skills under differing levels of supervision. This variability of knowledge and experience with procedural skills can place patient safety at risk. Consequently, in 2012, we developed a targeted, intensive, 3-day training course for our pre-intern (PrInt) students. The aim of this study was to evaluate the intern preparation package by exploring interns' self-reported knowledge, confidence, and experience in key procedural skills during the early months of internship.MethodsBetween 2012 and 2016, 5 cohorts of PrInt students (n=223) participated in our course. In the following years 2013-2017, the same 5 cohorts, at 4-5 months into their internship, were surveyed anonymously and invited to attend focus groups. Descriptive statistics and thematic analysis were used to analyze data.ResultsOf the 223 interns, 91 (41%) responded. Of the 91, 82 (93%) agreed that the intern preparation package provided during PrInt had been beneficial to their practice as an intern. Awareness of potential risks to patient safety was high, ranging from infection control at 89/89 (100%) to 87/90 (97%) for patient identification. Confidence in performing procedural skills varied from moderate in identifying nasogastric tube placement on X-ray (66/89; 85%), to equal least confidence in managing cardiac-related emergencies (53/90; 59%) and identifying the correct placement of peripherally inserted central catheter lines on X-ray (52/89; 58%).Major qualitative findingsThe preparation package had refreshed interns' procedural skills ability and awareness of risks to patient safety. Integration into the clinical team was positive, but requests to perform procedural skills on day 1 was unexpected.ConclusionInterns reported that they had gained substantial benefit from their preparation package, and they performed practical procedures from day 1, further highlighting the need for an intensive preparation course immediately prior to entering internship.

Dataset Information

SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer.

Background

Methods

Results

Conclusions

Trial registration

Publications

SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer.

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