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 ).
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.
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.
MULTIFILE
