(1) Background: Chemoradiotherapy (CRT) for head and neck cancer (HNC) is associated with severe toxicity resulting in fatigue and weight loss, including loss of skeletal muscle mass. Exercise interventions might positively affect physical fitness and quality of life. Sufficient adherence and compliance rates are necessary for optimal effects. This study aimed to gain insight into expectations and experiences and factors influencing adherence, retention and compliance of HNC patients participating in exercise intervention during CRT. (2) Methods: Consecutive participants were invited for semi-structured interviews, conducted pre- and post-intervention. A deductive approach was used to identify themes and factors influencing adherence, retention and compliance. (3) Results: Thematic saturation was reached after interviewing 14 patients pre-intervention. Five themes were identified: planning and time management, treatment toxicity, motivation to exercise, exercise intervention and supervision by a physiotherapist. The intensity of the treatment schedule and treatment toxicity were important barriers. Facilitators mentioned were physical and emotional benefits, social support as well as the simplicity and home-based setting of the intervention. (4) Conclusions: A personalised approach, considering the individual facilitators and barriers of HNC patients, is important to increase adherence, retention and compliance to exercise intervention and to reap the optimal effects of the program.
INTRODUCTION: Innovations in head and neck cancer (HNC) treatment are often subject to economic evaluation prior to their reimbursement and subsequent access for patients. Mapping functions facilitate economic evaluation of new treatments when the required utility data is absent, but quality of life data is available. The objective of this study is to develop a mapping function translating the EORTC QLQ-C30 to EQ-5D-derived utilities for HNC through regression modeling, and to explore the added value of disease-specific EORTC QLQ-H&N35 scales to the model.METHODS: Data was obtained on patients with primary HNC treated with curative intent derived from two hospitals. Model development was conducted in two phases: 1. Predictor selection based on theory- and data-driven methods, resulting in three sets of potential predictors from the quality of life questionnaires; 2. Selection of the best out of four methods: ordinary-least squares, mixed-effects linear, Cox and beta regression, using the first set of predictors from EORTC QLQ-C30 scales with most correspondence to EQ-5D dimensions. Using a stepwise approach, we assessed added values of predictors in the other two sets. Model fit was assessed using Akaike and Bayesian Information Criterion (AIC and BIC) and model performance was evaluated by MAE, RMSE and limits of agreement (LOA).RESULTS: The beta regression model showed best model fit, with global health status, physical-, role- and emotional functioning and pain scales as predictors. Adding HNC-specific scales did not improve the model. Model performance was reasonable; R2 = 0.39, MAE = 0.0949, RMSE = 0.1209, 95% LOA of -0.243 to 0.231 (bias -0.01), with an error correlation of 0.32. The estimated shrinkage factor was 0.90.CONCLUSIONS: Selected scales from the EORTC QLQ-C30 can be used to estimate utilities for HNC using beta regression. Including EORTC QLQ-H&N35 scales does not improve the mapping function. The mapping model may serve as a tool to enable cost-effectiveness analyses of innovative HNC treatments, for example for reimbursement issues. Further research should assess the robustness and generalizability of the function by validating the model in an external cohort of HNC patients.
Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
