Methods and Study Design Sample Clauses

Methods and Study Design. Based on the first results from (baseline to months 3-6) of the BOUNCE prospective pilot study, a mental health status at the start of the oncological treatments in participants with early breast cancer will be evaluated. After oncologist´s appointment patients willing to participate will fill in baseline information about their psychosocial wellbeing and sociodemographic factors to Xxxxx, similarly as described in this protocol earlier for the BOUNCE prospective pilot study. At baseline, the trial assistant will introduce the Noona platform face to face to the participants. The trial assistant will also collect data about the tumour characteristics and treatments received from the patient records of the hospital The information used will be a set of questionnaires and those parameters that predicted the resilience trajectory in the multicenter clinical pilot study described in the study protocol. The collected and pseudonymized data of each participant will be exported from Noona platform to FORTH. This will provide input to a decision support system to predict mental well-being for the following months based on the four models of anxiety and depression. The platform will also provide a recommendation if amount of exercise is sufficient compared to recommendations based on the amount of exercise patient have recommended. This amount will be compared to the general recommendations (UKK Institute). The participants will be classified to have a good, intermediate or poor resilience (Table 9). In this testing pilot good resilience means that all the mental health models shows a good mental health during the following months and the amount of exercise is sufficient, poor resilience means that all the mental health models show risk for problems during the following months and the amount of exercise is insufficient. Intermediate resilience means that some of the models show impairment during the following months and/ or the amount of exercise is insufficient. Participants with an impaired resilience (intermediate or poor score) at baseline or with a risk for impaired resilience score in the future, will be offered targeted interventions based on the factors that impaired their resilience. A trial nurse will select the interventions needed for each participant separately. The intervention methods will be a patient empowerment module in the Noona platform, physical exercise through an online group and online nutrition counselling. Nutrition counselling is selected...
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Methods and Study Design. The particular data set has originated from an observational retrospective design: it looks backwards to medical, functional, demographic, and psychometric data collected and stored in the IEO databases and examines the correlation between biological and psychological factors. The data pertains to all the IEO breast cancer patients treated with curative intent until 2017. All the psychological, functional and biomedicall data that will be extracted from the existing databases is listed in Table R2.1, Table R2.2, Table R2.3 and R2.4. D4.1 Preliminary Fact Grant Agreement no.
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Methods and Study Design. Primary and secondary endpoints will be reached through a large scale multi-center study at four clinical centres: • European Institute of Oncology (IEO), • Xxxxx Medical Center/Shaare Zedek Medical Center/Xxxxxx Medical Center [coordinated by HUJI] • Helsinki University Hospital – HUS (Finland, Coordinator of The Project), • Champalimaud Foundation (CHAMP, Portugal).
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Methods and Study Design 
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Related to Methods and Study Design

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

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