Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-24 @ 11:33 PM
Ignite Modification Date: 2025-12-24 @ 11:33 PM
NCT ID: NCT04318756
Brief Summary: An Italian language version of the Cancer Worry Scale is not available yet. The aim of this study is to develop and validate the Italian version of Cancer Worry Scale through subjects at high risk of pancreatic cancer for familiarity/genetic predisposition, or suffering from premalignant cystic lesions.
Detailed Description: The Fear of Cancer remains a significant problem for subjects enrolled surveillance programs. This emotional condition can influence the patients' wellbeing and their adherence to treatments. No results coming from the application of Cancer Worry Scale on high-risk of Pancreatic cancer individuals have been provided yet. The fear is an emotional reaction that can be the result of interpretation and cognitions of perceived internal cues and/or external cues. To objectify this emotion, a cancer worry scale, has been developed to investigate the fear in female breast cancer survivors. The proposed scale assesses the psychological distress caused by fear of cancer. The detection of high level of fear can prevent problematic behaviours, including anxious preoccupation, avoidance, and excessive checking, and moreover it can help patients to reduce difficulties in performing the individual's daily and social activities. The scale could use to evaluate the psychological burden produced by the enrolment in a surveillance program due to a certain predisposition to Pancreatic cancer. One step forward will be to manage those individuals with high-level of Fear of cancer, providing them a proper psychological support. At the General and Pancreatic Surgery Unit of the Pancreas Institute, some experimental self-made psychological support programs that investigate different psychologic distress through validated instruments, like anxiety, depression, perceived stress and global assessment or quality of life have been built up. It must be noted that the scale is not available specifically for Pancreatic cancer (originally it was created for breast cancer) , and for the Italian language, thus it has never been applied in an italian surveillance/follow-up program dealing with Pancreatic cancer. Nowadays, there is only a well-structured paper assessing psychological factors associated with cancer worries in high risk participants in a pancreatic cancer surveillance program. Differently than what has been already reported by Konings et al, the cohorts of patients that will be considered are heterogeneous, reflecting more accurately the real-life scenario of the subjects to whom the scale is administered to. In addition, this may help to identify those individuals that may benefit from a psychological support, in order to prevent a withdrawal from the surveillance program. However, a cut-off has not been provided yet. With next step study we'll aim at determining a cut-off for the detection clinically relevant worry for cancer.
Study: NCT04318756
Study Brief:
Protocol Section: NCT04318756