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Electronic Swallowing Intervention Package to Support Swallowing Function in Patients With Head and Neck Cancer: Development and Feasibility Study.

ABSTRACT: 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.

SUBMITTER: Cowie J

PROVIDER: S-EPMC6181202 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Electronic Swallowing Intervention Package to Support Swallowing Function in Patients With Head and Neck Cancer: Development and Feasibility Study.

Cowie Julie J Boa Sally S King Emma E Wells Mary M Cairns David D

JMIR formative research 20180801 2

<h4>Background</h4>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 ...[more]

PMID: 30320300

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Project description:BackgroundDysphagia 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.MethodsThis 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.ResultsA 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.ConclusionsA 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 registrationISRCTN40215425, registered retrospectively.

Project description:IntroductionNurse and pharmacist independent prescribers manage patients with respiratory tract infections and are responsible for around 8% of all primary care antibiotic prescriptions. A range of factors influence the prescribing behaviour of these professionals, however, there are no interventions available specifically to support appropriate antibiotic prescribing behaviour by these groups. The aims of this paper are to describe (1) the development of an intervention to support appropriate antibiotic prescribing by nurse and pharmacist independent prescribers and (2) an acceptability and feasibility study designed to test its implementation with these prescribers. METHOD AND ANALYSIS: Development of intervention: a three-stage, eight-step method was used to identify relevant determinants of behaviour change and intervention components based on the Behaviour Change Wheel. The intervention is an online resource comprising underpinning knowledge and an interactive animation with a variety of open and closed questions to assess understanding. Acceptability and feasibility of intervention: nurse and pharmacist prescribers (n=12-15) will use the intervention. Evaluation includes semi-structured interviews to capture information about how the user reacts to the design, delivery and content of the intervention and influences on understanding and engagement, and a pre-post survey to assess participants' perceptions of the impact of the intervention on knowledge, confidence and usefulness in terms of application to practice. Taking an initial inductive approach, data from interview transcripts will be coded and then analysed to derive themes. These themes will then be deductively mapped to the Capability, Opportunity, Motivation-Behaviour model. Descriptive statistics will be used to analyse the survey data, and trends identified.Ethics and disseminationEthical approval for the study has been provided by the School of Healthcare Sciences Research Governance and Ethics Committee, Cardiff University. The findings will be disseminated via publication in peer-reviewed journals and through conference presentations.

Project description:IntroductionIt is strongly recommended that randomised controlled trials are preceded with an exploration of the needs of the target population and feasibility testing of the intervention. The present study protocol is set out to describe these steps in the development of a complex intervention.The past decades' transition of care from inpatient to outpatient settings has increased the complexity of caregivers' responsibilities, which they may not be prepared for. There is a need to support informal caregivers (ICs) to prepare them for caregiving and decrease the caregiver burden. The main aim of this study is to describe the development of an internet-based intervention (Carer eSupport) to improve ICs' ability to support individuals with head and neck cancer and to describe the testing of the feasibility and acceptability of Carer eSupport.Methods and analysisThis is a multicentre study involving the ear, nose and throat clinics and the oncology and radiotherapy clinics at three university hospitals. The study protocol comprises two phases, development and feasibility testing, using the Medical Research Council framework for developing a complex intervention. Carer eSupport will be based on the results from focus group discussions with ICs and healthcare professionals (planned for n=6-8 in respective groups) and scientific evidence, the Social Cognitive Theory and the Theory of Acceptance and Use of Technology. The feasibility testing will include 30 ICs who will have access to Carer eSupport for 1 month. The feasibility testing will be evaluated with a mixed-method design.Ethics and disseminationAll procedures have been approved by the Ethics Committee at Uppsala University (Dnr: 2020-04650). Informed consent will be obtained before enrolment of patients, their ICs and healthcare staff. The feasibility testing is registered at Clinicaltrials.gov (Identifier: NCT05028452). Findings will be disseminated in peer-reviewed journal publications.Trial registration numberClinicaltrials.gov (Identifier: NCT05028452).

Project description:Purpose: To evaluate the accuracy of deep-learning-based auto-segmentation of the superior constrictor, middle constrictor, inferior constrictor, and larynx in comparison with a traditional multi-atlas-based method. Methods and Materials: One hundred and five computed tomography image datasets from 83 head and neck cancer patients were retrospectively collected and the superior constrictor, middle constrictor, inferior constrictor, and larynx were analyzed for deep-learning versus multi-atlas-based segmentation. Eighty-three computed tomography images (40 diagnostic computed tomography and 43 planning computed tomography) were used for training the convolutional neural network, and for atlas-based model training. The remaining 22 computed tomography datasets were used for validation of the atlas-based auto-segmentation versus deep-learning-based auto-segmentation contours, both of which were compared with the corresponding manual contours. Quantitative measures included Dice similarity coefficient, recall, precision, Hausdorff distance, 95th percentile of Hausdorff distance, and mean surface distance. Dosimetric differences between the auto-generated contours and manual contours were evaluated. Subjective evaluation was obtained from 3 clinical observers to blindly score the autosegmented structures based on the percentage of slices that require manual modification. Results: The deep-learning-based auto-segmentation versus atlas-based auto-segmentation results were compared for the superior constrictor, middle constrictor, inferior constrictor, and larynx. The mean Dice similarity coefficient values for the 4 structures were 0.67, 0.60, 0.65, and 0.84 for deep-learning-based auto-segmentation, whereas atlas-based auto-segmentation has Dice similarity coefficient results at 0.45, 0.36, 0.50, and 0.70, respectively. The mean 95th percentile of Hausdorff distance (cm) for the 4 structures were 0.41, 0.57, 0.59, and 0.54 for deep-learning-based auto-segmentation, but 0.78, 0.95, 0.96, and 1.23 for atlas-based auto-segmentation results, respectively. Similar mean dose differences were obtained from the 2 sets of autosegmented contours compared to manual contours. The dose-volume discrepancies and the average modification rates were higher with the atlas-based auto-segmentation contours. Conclusion: Swallowing-related structures are more accurately generated with DL-based versus atlas-based segmentation when compared with manual contours.

Project description:PurposeThe purpose of this paper was to design, manufacture, and evaluate a tissue equivalent, dual magnetic resonance/computed tomography (MR/CT) visible anthropomorphic head and neck (H&N) phantom. This phantom was specially designed as an end-to-end quality assurance (QA) tool for MR imaging guided radiotherapy (MRIgRT) systems participating in NCI-sponsored clinical trials.MethodThe MRIgRT H&N phantom was constructed using a water-fillable acrylic shell and a custom insert that mimics an organ at risk (OAR) and target structures. The insert consists of a primary and secondary planning target volume (PTV) manufactured of a synthetic Clear Ballistic gel, an acrylic OAR and surrounding tissue fabricated using melted Superflab. Radiochromic EBT3 film and thermoluminescent detectors (TLDs) were used to measure the dose distribution and absolute dose, respectively. The phantom was evaluated by conducting an end-to-end test that included: imaging on a GE Lightspeed CT simulator, planning on Monaco treatment planning software (TPS), verifying treatment setup with MR, and irradiating on Elekta's 1.5 T Unity MR linac system. The phantom was irradiated three times using the same plan to determine reproducibility. Three institutions, equipped with either ViewRay MRIdian 60 Co or ViewRay MRIdian Linac, were used to conduct a feasibility study by performing independent end-to-end studies. Thermoluminescent detectors were evaluated in both reproducibility and feasibility studies by comparing ratios of measured TLD to reported TPS calculated values. Radiochromic film was used to compare measured planar dose distributions to expected TPS distributions. Film was evaluated by using an in-house gamma analysis software to measure the discrepancies between film and TPS.ResultsThe MRIgRT H&N phantom on the Unity system resulted in reproducible TLD doses (SD < 1.5%). The measured TLD to calculated dose ratios for the Unity system ranged from 0.94 to 0.98. The Viewray dose result comparisons had a larger range (0.95-1.03) but these depended on the TPS dose calculations from each site. Using a 7%/4 mm gamma analysis, Viewray institutions had average axial and sagittal passing rates of 97.3% and 96.2% and the Unity system had average passing rates of 97.8% and 89.7%, respectively. All of the results were within the Imaging and Radiation Oncology Core in Houston (IROC-Houston) standard credentialing criteria of 7% on TLDs, and >85% of pixels passing gamma analysis using 7%/4 mm on films.ConclusionsAn MRIgRT H&N phantom that is tissue equivalent and visible on both CT and MR was developed. The results from initial reproducibility and feasibility testing of the MRIgRT H&N phantom using the tested MGIgRT systems suggests the phantom's potential utility as a credentialing tool for NCI-clinical trials.

Project description:BACKGROUND:Head and neck cancer survivors commonly experience severe long-term toxicities, late-occurring symptoms, and significant risks of the second primary malignancy and comorbid illnesses. With multiple simultaneous health issues, these complex cancer survivors often do not receive comprehensive health care that addresses their needs. A tool is needed to streamline and standardize comprehensive care for this cohort. METHODS/DESIGN:We designed the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) to address health care challenges for head and neck cancer survivors. HN-STAR is an electronic platform that aims to simplify the provision of personalized care in cancer survivorship clinics. It uses an algorithmic approach to integrate patient-reported outcomes, clinical details, and evidence-based guidelines to standardize comprehensive care provided in routine survivorship visits. It has four integrated components: (1) a simplified treatment summary, which pulls treatment details from a clinical database or can be completed manually using a streamlined form; (2) an online self-assessment for patients to report their own symptoms; (3) an interactive discussion guide presenting all relevant information to the provider during the clinic visit; and (4) a survivorship care plan generated at the end of each visit that reflects decisions made during the visit. By using a modifiable electronic platform, HN-STAR provides a method for incorporating survivorship care plans into clinical practice and for disseminating evidence on symptom management and preventive care. This is a study to assess the feasibility of a future multi-site, randomized clinical trial of HN-STAR. We will enroll head and neck cancer survivors who are followed in one of two nurse practitioner-led survivorship clinics. We will implement HN-STAR for one routine survivorship visits. We will assess (1) usability and feasibility outcomes of HN-STAR from the perspective of key stakeholders and (2) the planned outcomes intended for the larger trial. We will collect usability and feasibility data from online surveys of survivors and their providers. Our findings will inform whether it is feasible to advance HN-STAR to trial. If so, we will adapt HN-STAR and the study design of the trial in response to feedback from survivors and providers. The long-term goal is to determine if such an intervention will lead to improved and simplified comprehensive survivorship care. DISCUSSION:This feasibility study will evaluate implementation of HN-STAR into clinical practice in terms of usability, practicality, and clinical flow in two distinct clinical settings. This study will also provide critical baseline data to characterize this vulnerable population. Findings from this study will inform a multicenter randomized trial of HN-STAR, aimed at standardizing and streamlining the delivery of evidence-guided comprehensive care for head and neck cancer survivors. Ultimately, if found effective, the modular structure of HN-STAR could permit its expansion to survivors of other complex cancers. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02571673.

Dataset Information

Electronic Swallowing Intervention Package to Support Swallowing Function in Patients With Head and Neck Cancer: Development and Feasibility Study.

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Electronic Swallowing Intervention Package to Support Swallowing Function in Patients With Head and Neck Cancer: Development and Feasibility Study.

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