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:Background:Many patients undergoing treatment for head and neck cancer (HNC) experience significant swallowing difficulties, and there is some evidence that swallowing exercises may improve outcomes, including quality of life. This feasibility study developed an evidence-based, practical Swallowing Intervention Package (SiP) for patients undergoing chemoradiotherapy (CRT) for HNC. As part of the study, an electronic version of SiP (e-SiP) was concurrently developed to support patients to self-manage during treatment. This paper reports on the e-SiP component of this work. Objective:The objective of our study was to develop and conduct a preliminary evaluation of an electronic support system (e-SiP) for patients undergoing CRT for HNC. Methods:The study was conducted using a recognized mHealth development and evaluation framework and involved health professionals and patients who were undergoing CRT for HNC. The scoping stage of e-SiP development investigated the potential usefulness of the app, exploring how e-SiP would look and feel and what content would be appropriate to provide. Patient and carer focus groups and a health professionals' consensus day were used as means of data gathering around potential e-SiP content. A repeat focus group looked at an outline version of e-SiP and informed the next stage of its development with regard to refining the requirements for the tool. This was followed by further development and a testing stage of e-SiP that involved the coding of a prototype, which was then evaluated using a series of steering group meetings, semistructured interviews with both patients and health care professionals, and analysis of e-SiP log data. Results:Feedback from focus groups and health professional interviews was very positive, and it was felt e-SiP use would support and encourage patients in conducting their swallowing exercises. However, of the 10 patients who were offered e-SiP, only 2 opted to use it. For these patients, the aspects of the e-SiP app were considered useful, in particular, the ease of keeping a diary of exercises performed. Interviews with users and nonusers suggested significant barriers to its use. Most significantly, the lack of flexibility of the platform on which e-SiP could be accessed appeared a dominant factor in deterring e-SiP use. Conclusions:The results suggest that further research needs to be conducted around the implementation of e-SiP. This involves evaluating how e-SiP can be better integrated into usual care and through patient training and staff engagement, can be perceived as a beneficial tool to help support patients in conducting swallowing exercises.

Project description:IntroductionPeople often experience distress following stroke due to fundamental challenges to their identity.ObjectivesTo evaluate (1) the acceptability of 'HeART of Stroke' (HoS), a community-based arts and health group intervention, to increase psychological well-being; and (2) the feasibility of a definitive randomised controlled trial (RCT).DesignTwo-centre, 24-month, parallel-arm RCT with qualitative and economic components. Randomisation was stratified by centre and stroke severity. Participant blinding was not possible. Outcome assessment blinding was attempted.SettingCommunity.ParticipantsCommunity-dwelling adults ≤2 years poststroke recruited via hospital clinical teams/databases or community stroke/rehabilitation teams.InterventionsArtist-facilitated arts and health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC.OutcomesThe outcomes were self-reported measures of well-being, mood, capability, health-related quality of life, self-esteem and self-concept (baseline and 5 months postrandomisation). Key feasibility parameters were gathered, data collection methods were piloted, and participant interviews (n=24) explored the acceptability of the intervention and study processes.ResultsDespite a low recruitment rate (14%; 95% CI 11% to 18%), 88% of the recruitment target was met, with 29 participants randomised to HoS and 27 to UC (57% male; mean (SD) age=70 (12.1) years; time since stroke=9 (6.1) months). Follow-up data were available for 47 of 56 (84%; 95% CI 72% to 91%). Completion rates for a study-specific resource use questionnaire were 79% and 68% (National Health Service and societal perspectives). Five people declined HoS postrandomisation; of the remaining 24 who attended, 83% attended ≥6 sessions. Preliminary effect sizes for candidate primary outcomes were in the direction of benefit for the HoS arm. Participants found study processes acceptable. The intervention cost an estimated £456 per person and was well-received (no intervention-related serious adverse events were reported).ConclusionsFindings from this first community-based study of an arts and health intervention for people poststroke suggest a definitive RCT is feasible. Recruitment methods will be revised.Trial registration numberISRCTN99728983.

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Project description:IntroductionPeople with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK.Methods and analysisA multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial.Ethics and disseminationThe study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants.Trial registration numbersISRCTN80475744; Pre-results.

Project description:On 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.Between 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.Of 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%).The 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.Interns 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.

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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.

Similar Datasets

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