Effectiveness of an evidence-based swallowing facilitation strategy for patients undergoing radiotherapy for head and neck cancer: a study protocol for a randomised controlled trial

Strengths and limitations of this study

  • The content of the programme is meticulously developed on the foundation of validated evidence, endorsed by both oncologists and clinical nursing experts specialised in oncology. It embodies scientific integrity, practicality and feasibility.

  • This study protocol employs varied strategies to boost patient adherence, pivotal for improving outcomes and regression.

  • Blinding of assessors and statistical analysts will be meticulously executed, with proficient statistical experts carrying out the statistical analysis.

  • The protocol is intricately detailed and can be easily replicated. It will serve as a fundamental blueprint for future replication in patients undergoing radiotherapy for head and neck cancer across different levels of care.

  • The study is conducted at a single centre, encompassing a small sample size and a concise intervention and observation period.

Introduction

Dysphagia stands as one of the most prevalent adverse effects subsequent to radiotherapy for head and neck cancer (HNC).1 It commonly presents as symptoms including choking, delayed swallowing, food retention or adhesion within the oral cavity, coupled with alterations in dietary behaviours.2 These manifestations collectively result in an impaired capacity to safely and efficiently convey food, drink and secretions into the gastric region.3 Within the context of radiotherapy, dysphagia often emerges alongside treatment-induced tissue inflammation, oedema, pain, mucus secretion and dry mouth. Post-treatment, reduced swallowing function results from muscle and soft tissue fibrosis, lymphoedema and neuropathy in the oral and throat regions, potentially persisting and significantly affecting patients’ lives.4 5 Literature reports that approximately 30% to 80% of HNC patients have varying degrees of dysphagia postradiotherapy,6–8 with 60% ranking it as their most distressing post-treatment symptom.9 Dysphagia caused by radiotherapy and chemotherapy can not only accelerate weight loss and increase the risk of malnutrition10 but also lead to dehydration,11 aspiration, aspiration pneumonia and many other adverse outcomes.12 Furthermore, it has been linked to psychological and social interaction disorders.13 Consequently, the early identification and intervention of dysphagia in patients undergoing radiotherapy for HNC stand as a critical imperative.

Patients are usually diagnosed and treated by tertiary or specialist hospitals and then discharged and transferred to other secondary hospitals, community hospitals, homes and other rehabilitation settings. Still, there is a lack of uniform and operational practice norms for their swallowing facilitation strategy, making it difficult for patients to access sustained and systematic rehabilitation measures. As dysphagia in patients undergoing radiotherapy for HNC may continue to develop and plague patients for an extended period,14 a consistent and systematic swallowing facilitation strategy is essential to improve patients’ swallowing and reduce the occurrence of related complications.

Evidence-based research on dysphagia provides a crucial foundation for optimising the role of caregivers in promoting swallowing rehabilitation in patients undergoing radiotherapy for HNC. Among the commonly used techniques, preventive swallowing training is an intervention aimed at improving swallowing function in HNC patients undergoing radiotherapy. This approach, through enhanced training of jaw, lip and tongue movements and motor control of the soft palate and vocal fold closure, can strengthen muscles and improve the coordination and range of motion of the relevant muscle groups (jaws, root of the tongue, pharyngeal constrictors, laryngeal raphe and internal retractors including the supraglottis muscles), reducing the resistance of food as it passes through the oesophagus.15–17 At the same time, increased pharyngeal activity promotes blood circulation, which aids in the repair of mucosal damage and reduces oedema. However, although the effects of preventive swallowing training on physiological aspects of swallowing are relatively well established, their impact on patients’ overall swallowing-related quality of life remains less clear.18 In addition, feeding management interventions have been introduced to adjust the amount and rate of eating to reduce the risk of aspiration.19 Changing the eating position can result in changes in the size of the swallowing passage and direction of food flow and in the position of certain swallowing organ constituent structures (eg, tongue, pharynx, arytenoid cartilage), thereby reducing symptoms such as choking, retention and aspiration.20 Dietary modifications usually involve changing the volume and consistency of food before eating, such as thickening beverages. One study concludes that the use of thickened liquids may improve patients’ swallowing function by slowing fluid flow, improving laryngeal elevation and providing haptic feedback.21–23 However, there are also studies suggesting that this method leads to an increase in pharyngeal retention.19 However, most studies have concluded that feeding management, which is primarily aimed at improving food flow and reducing aspiration, struggles to produce lasting changes in swallowing physiology,24 and there is limited evidence to support this strategy. It is included as a new component of this programme to further explore its potential benefits.

Hence, we have meticulously examined and refined an evidence-based swallowing facilitation strategy involving preventive swallowing training and feeding management measures, aiming to fill the gaps in the existing literature. Under the guidance of HNC experts and nursing professionals, we subjected these measures to rigorous scrutiny and thoughtful consideration. Subsequently, we will implement and evaluate the programme’s effectiveness in improving patients’ safe swallowing of diverse foods, enhancing their swallowing-related quality of life and boosting nutritional status.

Materials and methods

Study design and setting

This study is a single-centre, prospective, randomised, parallel-controlled trial. This study aims to implement and validate the programme both at Shanghai Proton Heavy Ion Hospital and in the homes of discharged patients. The effectiveness of these components in enhancing swallowing function, nutritional status and swallowing-related quality of life will be assessed in HNC patients 3 months after the completion of radiotherapy.

The study protocol was not designed to include a Sham training group in mind. This decision was primarily driven by ethical considerations, and given that this study employs subjective assessment tools for evaluating effectiveness, introducing a Sham training group could potentially introduce a placebo effect. The content of the intervention programme in this study makes it impractical to achieve complete blinding for both patients and intervention implementers. The protocol will be reported by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines25 and written using the SPIRIT checklist (online supplemental file 1). Protocol implementation will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) to ensure the standardisation of studies.

Supplemental material

Participants and recruitment

The study is scheduled to commence in March 2023 and conclude in March 2024. Recruitment of participants will follow a continuous enrolment approach, involving nurses with a minimum of 1-year experience in head and neck oncology. On applying the inclusion and exclusion criteria, eligible subjects will be enrolled. The complete inclusion of all patients will require a minimum of 3 months.

Patients meeting the inclusion criteria and expressing willingness to participate, alongside their families, will receive a comprehensive study overview. Subsequently, they will provide written informed consent by signing the provided document (online supplemental file 2), thus finalising the baseline survey. Baseline assessments will encompass demographical and medical information of patients (such as age, gender, residence, tumour location, staging, radiotherapy modality and dose), swallowing function, swallowing-related quality of life and nutritional status.

Supplemental material

Inclusion criteria

  • Age: 18–80 years.

  • Pathological diagnosis: HNC, including primary sites like oral/nasal cavities, pharynx, larynx, maxillofacial region, salivary glands, neck.

  • Radiation therapy, with/without chemotherapy; total dose, 40–75 Gy (5 fractions/week); treatment duration, 4–7 weeks.

  • The patient was informed about the tumour diagnosis.

  • Able to communicate and answer questions.

  • Literate and able to use electronic tools such as WeChat.

  • Voluntary participation with signed informed consent.

Exclusion criteria

  • Previous HNC or head/neck radiation.

  • Received laryngectomy or tracheotomy.

  • Dysphagia is due to causes other than cancer, such as other central nervous system disorders, muscular disorders, trauma or disease of the oral and jaw joints, etc.

  • Dysphagia or difficulty opening the mouth is initial tumour symptom.

  • Acute disease phase or severe organ function impairment.

  • Severe mental or cognitive impairment.

Patient and public involvement

None. Patients and the public recruited for this study are not involved in this research’s design, execute, reporting or dissemination plans.

Sample size calculation

The primary metric of interest in this study is swallowing function. Sample size determination is conducted using the method of repeated measures analysis of variance. The calculation follows the module for testing the means of two groups in a repeated measures design as per PASS 2022. D1 represents the difference between the means of the two groups, S signifies the SD and assuming equal SD in the two groups, M denotes the repeated measurement time points.

Through a literature review, data extracted from a study that implemented preventive swallowing training for patients undergoing HNC radiotherapy reveals a mean swallowing function score of (22.60±2.39).26 With parameters set at D1=1.63, S=2.39 and M=3, and bilateral α=0.05, β=0.10 and ρ at 0.7, the calculated sample size results in n1=n2=37, totalling 74 cases. Accounting for potential missed visits during the study, a sample size of 94 cases is determined.

Randomisation and allocation concealment

After patients complete the baseline survey, another researcher who is not involved in the recruitment will group the patients using a zonal randomised grouping method.

(1) a block length of 4 is set, and subjects in each block are randomly assigned in a ratio of 1:1 to form six-block arrangements; (2) possible block arrangements are coded from 1 to 6; (3) six consecutive random numbers are arbitrarily selected using a random number table, and the random numbers are sorted from smallest to largest, and the corresponding coded blocks are arranged according to the sorted numbers; (4) subjects are numbered and entered into the arranged blocks in order starting with number 1.

The grouping scheme is placed sequentially in non-transparent, sealed envelopes and placed on the interventionist’s desk. The random numbers are checked after the study subjects are enrolled to determine entry into the intervention or control group.

Intervention

The intervention will be administered by a nurse from the head and neck oncology department who has undergone 2 to 3 months of swallowing rehabilitation training. This training, led by a speech-language pathologist with extensive experience in head and neck oncology, encompasses various facets of swallowing facilitation strategies and usual care. Following the training, participants will receive a knowledge assessment questionnaire on the topic developed by the research team. The interventionist is the only person with an allocation list and implements the programme according to the participant’s number without knowing the baseline assessment results.

Control group produce

Patients assigned to the control group will receive the usual care designed for HNC undergoing radiotherapy. This care is initiated on the commencement of radiation therapy and continues up to 3 months after the conclusion of radiation treatment. Furthermore, patients will be provided with pertinent health education manuals. The standard care comprises several components, including (1) health education with a focus on preventive swallowing training and (2) comprehensive guidance on feeding management, encompassing details about appropriate food types, textures and portion sizes. Adherence data for the standard care protocol is gathered through regular assessments carried out by healthcare professionals during patients’ visits, in addition to weekly evaluations following discharge.

Intervention group produce

In addition to receiving conventional care and health education, the intervention group will implement a swallowing facilitation strategy for patients undergoing radiotherapy for HNC, as detailed in table 1. The intervention time for patients in the intervention group will be the same as the usual care time for patients in the control group. As a part of the intervention, preventive swallowing training will be administered at the initiation of radiotherapy. In cases where patients exhibit symptoms such as food adherence sensation in the throat; choking or clearing the throat during meals; preswallow coughing, midswallow coughing or postswallow coughing or abnormal postswallow vocal quality,5 measures from the feeding management portion are introduced.

Table 1

Swallowing function promotion strategies

Strategies to improve adherence

Throughout the hospitalisation period, several measures will be taken to facilitate effective swallowing rehabilitation: (1) Each patient will receive a comprehensive swallowing rehabilitation instruction manual paired with an instructional video which features a clear and concise narrative, accompanied by a detailed breakdown of the required movements. (2) A daily live demonstration will be conducted by the intervention facilitator to guide patients through the preventive swallowing training. Furthermore, they will actively monitor and assess patients’ exercise performance on-site. In instances where patients faced difficulties or displayed incorrect execution, comprehensive notes are recorded by the intervention facilitator, outlining the issues and detailing the corrective measures taken. (3) Each patient will diligently participate in the swallowing training routine, engaging in three sessions daily. Each session spans 10 to 15 min, during which they iterate through each movement a minimum of 10 times. The training schedule includes specific times and levels of completion.

Postdischarge: (1) On the day prior to discharge, patients and families will be reminded of the programme’s importance and instructed to continue preventive swallowing training and feeding management using provided materials postdischarge. (2) Researchers will guide patients on a weekly basis via WeChat based on the programme content and remind them to fill out the swallowing training plan to register and monitor programme adherence. If the patient’s absence exceeds 15%, they will be treated as lost to follow-up.

Outcomes and outcome measures

The main focus will be on comparing the occurrence and seriousness of dysphagia among patients in the intervention group, who undergo swallowing facilitation strategies, and the control group, who receive usual care. Additionally, secondary assessments will delve into the disparity in swallowing-related quality of life and nutritional status between the two groups.

Primary outcome

Swallowing function

Using a functional oral intake scale (FOIS) as the primary method for swallowing function screening, in conjunction with Eating Assessment Tool-10 (EAT-10), can enhance the sensitivity and specificity of dysphagia assessment. This approach also facilitates the dynamic evaluation of patients’ swallowing function over time.

There are seven levels of FOIS: level 1, no oral feeding; level 2, dependent on tube feeding with minimal attempts at feeding; level 3, dependent on tube feeding with oral feeding and single textured food; level 4, entirely oral feeding with single textured food; level 5, entirely oral feeding with multiple textured foods and special preparations; level 6, entirely oral feeding without special preparations and restrictions on special foods; level 7, entirely oral feeding with no restrictions on special foods, no limits.27 This classification system offers vital insights into the specific textured foods patients should incorporate or avoid during oral feeding and whether nutritional supplementation through percutaneous endoscopic gastrostomy (PEG) tube feeding is necessary.16 28

The EAT-10 questionnaire comprises 10 individual items focused on symptoms, clinical characteristics, social implications and psychological perceptions related to dysphagia during the oropharyngeal phase. Employing a 5-point Likert scale (ranging from 0 to 4), scores are summed directly, with higher values reflecting greater dysphagia severity.29 Printza et al conducted a study on the reliability of the EAT-10 in patients recovering from dysphagia post-HNC treatment.30 They report a Cronbach’s α coefficient of 0.963 and a retest reliability Spearman coefficient ranging from 0.937 to 1. The EAT-10 questionnaire’s brevity and focused nature aid in the identification of signs of aspiration, covert aspiration and aberrant swallowing behaviours. The ‘Chinese Expert Consensus on Swallowing Disorder Rehabilitation Assessment and Treatment’ (2013 edition) has translated and endorsed the EAT-10.31 This study intends to use the EAT-10 scale to document patients’ self-awareness of the extent of their dysphagia.

Secondary outcomes

Secondary outcome indicators include the swallowing quality of life and nutritional status, measured by the MD Anderson Dysphagia Inventory (MDADI) and the Nutrition Risk Screening Instrument 2002 (NRS 2002), respectively.

Swallowing-related quality of life

The MDADI serves as a self-assessment tool specifically designed to elucidate the ramifications of dysphagia on the quality of life in individuals with HNC.32 The scale comprises four dimensions: emotional (6 items), physical (8 items), functional (5 items) and general condition (1 item), totalling 20 items scored on a 5-point Likert scale. The total score ranges from 20 to 100, where higher scores indicate better swallowing-related quality of life. Changes in patients’ swallowing-related quality of life were considered clinically significant when the difference in MDADI scores exceeded 10 points.33 The Chinese version demonstrates a Cronbach’s α coefficient of 0.9 and content validity of 0.94.34

Nutritional risks

The NRS 2002 encompasses three primary dimensions: disease status (including factors like oncology patient status, presence of diabetes, acute and chronic episodes, etc.), nutritional status (assessing body mass index, history of body mass loss and food intake) and whether age ≥70. The scale is scored from 0 to 7, with a score of ≥3 indicating a nutritional risk.35 The European Society for Clinical Nutrition and Metabolism has endorsed this scale as a recommended nutritional screening tool for inpatients. Its efficacy lies in its ability to effectively pinpoint patients at nutritional risk.36

Data collection

In this study, an independent head and neck oncology nurse, who is not engaged in other research procedures, conducts the assessment of objective swallowing function. The nurse underwent standardised training to ensure uniform administration and data collection for all scales. Prior to data collection, the nurse provides a clear explanation of the survey’s objectives and methodology to the participants. The completion of scales takes place on-site, with immediate collection, while any incomplete entries are addressed by having patients fill in the missing information and ensure accuracy.

The baseline survey includes the Socio-Demographic Questionnaire, FOIS, EAT-10, MDADI and NRS 2002.35 Demographical information will be self-reported by the patients, while the disease-related segment will be completed by the nurse based on case records. Follow-up assessments will occur postradiotherapy and at the 3-month mark, involving on-site scale distribution after radiotherapy and electronic distribution via micro-mail for the 3-month evaluation.

Participant timeline

Table 2 presents the trial timeline.

Table 2

Schedule of enrolment, interventions and assessments

Blinding

The study protocol incorporates swallowing training and feeding management, rendering blinding unattainable for both the interventionists and participants. However, to alleviate measurement bias, the assessment will be carried out by nurses who are unaware of the allocation and have been practising in the head and neck oncology unit for at least 1 year. Rigorous training in scale content and communication skills will be imparted to all assessors, and a preliminary assessment will be conducted to avoid bias caused by differential treatment of patients. Finally, the statistical analysis will be carried out by professional statistical experts and will be blinded to them.

Ethics and dissemination

This research initiative has been granted approval by the Ethics Committee of the Shanghai Proton Heavy Ion Hospital under the reference number 2210-59-01. During the recruitment process, patients will be thoroughly briefed on the study’s principal objectives and procedures, and their voluntary participation will be confirmed through the signing of an informed consent form. Participants maintain the prerogative to withdraw from the intervention at any juncture due to health concerns, with no implications for diagnostic, treatment or care-related activities. The study has been officially registered with the Chinese Clinical Trials Registry, bearing registration number ChiCTR2300067550 since 11 January 2023.

Statistical analysis

Accomplished statistical experts will spearhead the statistical analysis. Data entry uses EpiData V.3.0, and data analysis employs SPSS V.22.0 statistical software. Significance is determined at a two-sided p≤0.05. Baseline data for study subjects undergoes descriptive analysis. Normally distributed measurement data are presented as mean±SD and independent sample t-tests facilitated intergroup comparisons. Non-normally distributed measurement data are expressed as median and IQR, with the Mann-Whitney test applied for intergroup comparisons. Intergroup variations in statistical data and percentages are scrutinised through the χ2 test or Fisher’s exact test. Patients who were lost to follow-up or withdrew midway were analyzed using the Intention-to-Treat (ITT) approach. The R software was employed to construct Mixed Effect Models (MEM) for analyzing the swallowing function, swallowing-related quality of life, and nutritional status of the two groups at the end of radiotherapy and three months post-radiotherapy. Additionally, sensitivity analyses will fortify result robustness against attrition or treatment non-adherence scenarios.

Discussion

Several studies have suggested that combining swallowing training with eating and drinking management could enhance the restoration of swallowing function in patients undergoing HNC radiotherapy.22 37 However, the existing literature lacks definitive evidence regarding the intervention’s effectiveness. Most published systematic reviews on this intervention have yielded uncertain results.18 19 23 24 Considering this, there is a compelling necessity to conduct rigorous randomised controlled trials to gain a more comprehensive understanding of the therapeutic impact and suitability of this intervention for patients undergoing HNC radiotherapy.

This study carries significant implications for guiding the prevention and rehabilitation of dysphagia in patients undergoing radiotherapy for HNC. The primary goal of this research is to bridge the gap between evidence and clinical implementation by refining the content of preventive swallowing training and feeding management to enhance specificity and replicability. Subsequently, the research group will formally execute this randomised controlled trial. If the rehabilitative measures outlined in this protocol prove effective in enhancing swallowing function, elevating swallowing-related quality of life and mitigating malnutrition severity, they will serve as a crucial foundation for the wider application of these strategies in dysphagia rehabilitation for HNC radiotherapy patients across varying levels of care.

This study focuses on the effectiveness and organisational feasibility of the programme in the process of its development. The next phase of the study should encompass a comprehensive analysis of potential facilitators and barriers to the implementation of the developed programme. We intend to employ a mixed-methods approach, which will merge quantitative data on adherence rates and patient outcomes with qualitative perspectives from both patients and those implementing the intervention. Conducting a process evaluation will facilitate the assessment of potential greater variations among implementers, research contexts and participants that may arise in future shifts towards large-scale studies. This provides a reference for subsequent evidence interpretation, translation or further refinement of intervention programmes.

Moreover, this study is confined to a single centre, featuring a modest sample size and a relatively concise intervention and observation period. To enhance the programme’s efficacy and practicality, it’s imperative to undertake more expansive, multicentre studies spanning longer durations. Also, due to resource limitations, our study could only sustain longitudinal follow-up for up to 3 months post-treatment. Future investigations could explore the intervention’s effects at extended intervals, like 6 months, 9 months, 1 year or even more distantly after treatment cessation.

Trial status

The current pilot programme is V.2.0 as of 12 February 2023. Recruitment has yet to start, and participant recruitment begins on 1 March 2023 and will be open until March 2024.

Ethics statements

Patient consent for publication

Acknowledgments

We would like to thank the doctors and nurses of the head and neck oncology department at Shanghai Proton Heavy Ion Hospital for their help and support in the design of the content of this protocol and their suggestions for changes.

This post was originally published on https://bmjopen.bmj.com