OBJECTIVES: Expiratory muscle strength training (EMST) is a threshold based device-driven treatment for improving expiratory pressure. EMST proved to be effective in different patient groups to improve cough function. To date, EMST has not been tested in the total laryngectomy population (TL).METHODS: This prospective, randomized case-series study examined feasibility, safety, and compliance of EMST in a group of TL participants and its effects on pulmonary function, physical exertion, fatigue, and vocal functioning. Ten TL participants were included in the study to perform a 4 till 8 weeks of EMST. Objective and subjective outcome measures included manometry, spirometry, cardio pulmonary exercise testing (CPET), voice recordings, and patient reported outcome measures. Group means were reported and estimates of the effect are shown with a 95% confidence interval, using single sample t-tests.RESULTS: Nine participants completed the full study protocol. Compliance to the training program was high. All were able to perform the training, although it requires adjustments of the device and skills of the participants. Maximum expiratory pressure (MEP) and vocal functioning in loudness improved over time. After EMST no changes were seen in other objective and subjective outcomes.CONCLUSIONS: EMST appears to be feasible and safe after total laryngectomy. MEP improved over time but no improvement in the clinically relevant outcome measures were seen in this sample of relatively fit participants. Further investigation of the training in a larger group of participants who report specifically pulmonary complaints is recommended to investigate if the increase in MEP results in clinical benefits.LEVEL OF EVIDENCE: 4.
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Background Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application “In Tune without Cords” among patients treated with total laryngectomy. Methods/design Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application “In Tune without Cords”. Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up. Discussion This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.
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ObjectivesDecision-making for patients with a locally advanced laryngeal carcinoma (T3 and T4) is challenging due to the treatment choice between organ preservation and laryngectomy, both with different and high impact on function and quality of life (QoL). The complexity of these treatment decisions and their possible consequences might lead to decisional conflict (DC). This study aimed to explore the level of DC in locally advanced laryngeal carcinoma patients facing curative decision-making, and to identify possible associated factors.MethodsIn this multicenter prospective cohort study, participants completed questionnaires on DC, level of shared decision-making (SDM), and a knowledge test directly after counseling and 6 months after treatment. Descriptive statistics and Spearman correlation tests were used to analyze the data.ResultsDirectly after counseling, almost all participants (44/45; 98%) experienced Clinically Significant DC score (CSDC >25, scale 0–100). On average, patients scored 47% (SD 20%) correct on the knowledge test. Questions related to radiotherapy were answered best (69%, SD 29%), whilst only 35% (SD 29%) of the questions related to laryngectomy were answered correctly. Patients' perceived level of SDM (scale 0–100) was 70 (mean, SD 16.2), and for physicians this was 70 (SD 1.7).ConclusionMost patients with advanced larynx cancer experience high levels of DC. Low knowledge levels regarding treatment aspects indicate a need for better patient counseling.Level of Evidence4 Laryngoscope, 134:3604–3610, 2024
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Objective. After laryngectomy, the breathing resistance of heat and moisture exchangers may limit exercise capacity. Breathing gas analysis during cardiopulmonary exercise testing is not possible using regular masks. This study tested the feasibility of cardiopulmonary exercise testing with a heat and moisture exchanger in situ, using an in-house designed connector. Additionally, we explored the effect of different heat and moisture exchanger resistances on exercise capacity in this group. Methods. Ten participants underwent two cardiopulmonary exercise tests using their daily life heat and moisture exchanger (0.3 hPa or 0.6 hPa) and one specifically developed for activity (0.15 hPa). Heat and moisture exchanger order was randomised and blinded.Results. All participants completed both tests. No (serious) adverse events occurred. Only four subjects reached a respiratory exchange ratio of more than 1.1 in at least one test. Maximum exercise levels using heat and moisture exchangers with different resistances did not differ. Conclusion. Cardiopulmonary exercise testing in laryngectomees with a heat and moisture exchanger is feasible; however, the protocol does not seem appropriate to reach this group's maximal exercise capacity. Lowering heat and moisture exchanger resistance does not increase exercise capacity in this sample.
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OBJECTIVE: Patients diagnosed with advanced larynx cancer face a decisional process in which they can choose between radiotherapy, chemoradiotherapy, or a total laryngectomy with adjuvant radiotherapy. Clinicians do not always agree on the best clinical treatment, making the decisional process for patients a complex problem.METHODS: Guided by the International Patient Decision Aid (PDA) Standards, we followed three developmental phases for which we held semi-structured in-depth interviews with patients and physicians, thinking-out-loud sessions, and a study-specific questionnaire. Audio-recorded interviews were verbatim transcribed, thematically coded, and analyzed. Phase 1 consisted of an evaluation of the decisional needs and the regular counseling process; phase 2 tested the comprehensibility and usability of the PDA; and phase 3 beta tested the feasibility of the PDA.RESULTS: Patients and doctors agreed on the need for development of a PDA. Major revisions were conducted after phase 1 to improve the readability and replace the majority of text with video animations. Patients and physicians considered the PDA to be a major improvement to the current counseling process.CONCLUSION: This study describes the development of a comprehensible and easy-to-use online patient decision aid for advanced larynx cancer, which was found satisfactory by patients and physicians (available on www.treatmentchoice.info). The outcome of the interviews underscores the need for better patient counseling. The feasibility and satisfaction among newly diagnosed patients as well as doctors will need to be proven. To this end, we started a multicenter trial evaluating the PDA in clinical practice (ClinicalTrials.gov Identifier: NCT03292341).LEVEL OF EVIDENCE: NA Laryngoscope, 129:2733-2739, 2019.
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Purpose: Head and neck cancer (HNC) treatment often leads to physical and psychosocial impairments. Rehabilitation can overcome these limitations and improve quality of life. The aim of this study is to obtain an overview of rehabilitation care for HNC, and to investigate factors influencing rehabilitation provision, in Dutch HNC centers, and to some extent compare it to other countries. Methods: An online survey, covering five themes: organizational structure; rehabilitation interventions; financing; barriers and facilitators; satisfaction and future improvements, among HNC healthcare- and financial professionals of Dutch HNC centers. Results: Most centers (86%) applied some type of rehabilitation care, with variations in organizational structure. A speech language therapist, physiotherapist and dietitian were available in all centers, but other rehabilitation healthcare professionals in less than 60%. Facilitators for providing rehabilitation services included availability of a contact person, and positive attitude, motivation, and expertise of healthcare professionals. Barriers were lack of reimbursement, and patient related barriers including comorbidity, travel (time), low health literacy, limited financial capacity, and poor motivation. Conclusion: Although all HNC centers included offer rehabilitation services, there is substantial practice variation, both nationally and internationally. Factors influencing rehabilitation are related to the motivation and expertise of the treatment team, but also to reimbursement aspects and patient related factors. More research is needed to investigate the extent to which practice variation impacts individual patient outcomes and how to integrate HNC rehabilitation into routine clinical pathways.
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The consequences of head and neck cancer (HNC) treatment have great impact on patients' lives. Despite the importance of preparing patients for the period after discharge, patients frequently experience a lack of information. Aims of the study were to develop a nurse-led educational intervention to provide information during a discharge interview and to investigate the effects of the intervention on informational needs and satisfaction with information in HNC patients.
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BACKGROUND: Since 2011, a tailored, interdisciplinary head and neck rehabilitation (IHNR) program, covered by the basic healthcare insurance, is offered to advanced head and neck cancer (HNC) patients in the Netherlands Cancer Institute (NKI). This program is developed to preserve or restore patients' functioning, and to optimize health-related quality of life (HRQoL). It applies an integrated approach to define patients' individual goals and provide rehabilitation care throughout the cancer care continuum. The aim of the current study is to assess the (cost-) effectiveness of the IHNR approach compared to usual supportive care (USC) consisting of monodisciplinary and multidisciplinary care in advanced HNC patients.METHODS: This multicenter prospective observational study is designed to compare (cost-)effectiveness of the IHNR to USC for advanced HNC patients treated with chemoradiotherapy (CRT) or bioradiotherapy (BRT). The primary outcome is HRQoL represented in the EORTC QLQ-C30 summary score. Functional HRQoL, societal participation, utility values, return to work (RTW), unmet needs (UN), patient satisfaction and clinical outcomes are secondary outcomes, assessed using the EORTC QLQ-H&N35, USER-P, EQ-5D-5 L, and study-specific questionnaires, respectively. Both patient groups (required sample size: 64 per arm) are requested to complete the questionnaires at: diagnosis (baseline; T0), 3 months (T1), 6 months (T2), 9 months (T3) and 12 months (T4) after start of medical treatment. Differences in outcomes between the intervention and control group will be analyzed using mixed effects models, Chi-square test and descriptive statistics. In addition, a cost-effectiveness analysis (CEA) will be performed by means of a Markov decision model. The CEA will be performed using a societal perspective of the Netherlands.DISCUSSION: This prospective multicenter study will provide evidence on the effectiveness and cost-effectiveness of IHNR compared to USC. RTW and societal participation, included as secondary outcomes, have not been studied sufficiently yet in cancer rehabilitation. Interdisciplinary rehabilitation has not yet been implemented as usual care in all centers, which offers the opportunity to perform a controlled clinical study. If demonstrated to be (cost-)effective, national provision of the program can probably be advised.TRIAL REGISTRATION: The study has been retrospectively registered in the Netherlands Trial Registry on April 24th 2018 ( NTR7140 ).
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