Trials (Trinity St. James Cancer Institute)

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NCTID: NCT05947903

Title: Validation of the European Oncology Quality of Life Toolkit 
Study Summary: The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.  A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.  The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.  This is a multicentre observational study, with the following aims:  * The primary aim is to perform the psychometric validation of the EUonQoL-Kit. * Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries.  The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).  Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:  * EORTC QLQ-C30, to test concurrent validity. * Live-CAT version, to test the feasibility of such implementation. * EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability. 
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 
Intervention: Administration of the EUonQoL-Kit - Active Treatment questionnaire 
Start Date: 2024-04-01 
Last Updated: 2023-07-19 
Number of Patients: 4000 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Cancer 

NCTID: NCT06115629

Title: Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial 
Study Summary: Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years.  At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery.  The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up.  The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery. The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice. The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer. 
Sponsor: University of Dublin, Trinity College 
Intervention: Surveillance protocol 
Start Date: 2023-11 
Last Updated: 2023-11-03 
Number of Patients: 952 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Esophageal Cancer

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