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.
PURPOSE: The purpose of the study is to identify demographic, clinical, lifestyle-related, and social-cognitive correlates of physical activity (PA) intention and behavior in head and neck cancer (HNC) survivors using the theory of planned behavior (TPB).METHODS: Data from two cross-sectional studies on correlates of PA in HNC survivors were pooled. Both studies used self-reports to assess PA and social-cognitive correlates. Potential correlates were collected via self-report or medical records. Univariable and multivariable multilevel linear mixed-effects models were built to identify correlates of PA intention and PA behavior (Z scores). Structural equation model analyses were conducted to study the full TPB model in one analysis, taking into account relevant covariates.RESULTS: In total, 416 HNC survivors were surveyed. Their mean (SD) age was 66.6 (9.4) years; 64% were men, and 78% were diagnosed with laryngeal cancer. The structural equation model showed that PA intention was significantly higher in HNC survivors with a history of exercising, who had a more positive attitude, subjective norm, and perceived behavioral control. Patients with higher PA intention, higher PBC, a lower age, and without unintentional weight loss or comorbidities had higher PA behavior. The model explained 22.9% of the variance in PA intention and 16.1% of the variance in PA behavior.CONCLUSIONS: Despite significant pathways of the TPB model, the large proportion variance in PA intention and behavior remaining unexplained suggests the need for better PA behavior (change) models to guide the development of PA promotion programs, particularly for the elderly. Such programs should be tailored to comorbidities and nutritional status.
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Introduction. Despite the high number of inactive patients with COPD, not all inactive patients are referred to physical therapy, unlike recommendations of general practitioner (GP) guidelines. It is likely that GPs take other factors into account, determining a subpopulation that is treated by a physical therapist (PT). The aim of this study is to explore the phenotypic differences between inactive patients treated in GP practice and inactive patients treated in GP practice combined with PT. Additionally this study provides an overview of the phenotype of patients with COPD in PT practice. Methods. In a cross-sectional study, COPD patient characteristics were extracted from questionnaires. Differences regarding perceived health status, degree of airway obstruction, exacerbation frequency, and comorbidity were studied in a subgroup of 290 inactive patients and in all 438 patients. Results. Patients treated in GP practice combined with PT reported higher degree of airway obstruction,more exacerbations, more vascular comorbidity, and lower health status compared to patients who were not referred to and treated by a PT. Conclusion. Unequalpatient phenotypes in different primary care settings have important clinical implications. It can be carefully concluded that other factors, besides the level of inactivity, play a role in referral to PT.
