Chapter 3 Study objectives and general methodology

First, a pilot local study (at VHIO) was conducted to gather the first results about prostate cancer patients’ expectations under genomic testing, before the test, and after the communication of the results. This step will allow analyzing patients’ experience evaluation tools. Second, these preliminary findings will be validated by adapting the evaluation tools, sample size, study design, and intervention, in a multicenter study designed to evaluate the feasibility and impact of liquid biopsy-based genomic testing on treatment decision-making in metastatic prostate cancer patients.

Objectives:
* To develop an experience evaluation tool
* To evaluate prostate cancer patients’ experience during genomic testing, before and after pursuing the test
* To analyze the performance of the questionnaire developed
* To describe the findings obtained.

Study design: it is an observational prospective pilot study. Prostate cancer patients who are enrolled in a prospective genomic study currently in progress at VHIO, were invited to participate. An experience evaluation tool was built to assess patients’ expectations, concerns, and attitudes regarding genomic testing. This tool was implemented before and after pursuing the genomic testing. After this pilot study the results were analyzed descriptively and the experience evaluation tool was evaluated to determine its reliability and validity.
These findings will allow adjustment and improvement of the evaluation tools, and adequately design the multicenter study in a large patient cohort.

Experience evaluation tool: specific questionnaires covering different topics related to the patient experience around genomic testing and the communication of results were designed. To complete this task, a literature search was conducted and a few articles related to the study of genomic testing and knowledge, concerns, or expectations were found. All the questions were collected and analyzed. After evaluating the questions and the results published, some were selected to be incorporated into the experience evaluation tool because their responses showed a certain amount of variability and the relationship with the theoretical construct to assess. Most were modified to improve the content validity. Considering the scarcity of the tools available, the lack of validation, and the partial capacity of these items to be representative of the entire construct to measure (expectations, concerns, and attitudes about genomic testing in prostate cancer patients), several new questions were proposed and developed.
Patients completed the first questionnaire focused on expectations and concerns at their first visit when genomic testing was proposed. The questionnaire could be fulfilled at the Hospital or at home, according to patient preference. Assistance was offered for the completion of the evaluation tools.
Several weeks later, when the genomic testing was available, the physician explains the results to the patient. Then, the second questionnaire, focused on satisfaction and perception of uncertainties, was offered.

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