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2020-04-01
2020-06-30
2020-08-31
50
NCT04318756
Azienda Ospedaliera Universitaria Integrata Verona
Azienda Ospedaliera Universitaria Integrata Verona
OBSERVATIONAL
The Italian Version of Cancer Worry Scale
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-03-20 | N/A | 2020-03-20 |
2020-03-20 | N/A | 2020-03-24 |
2020-03-24 | N/A | 2020-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Italian patients suffering from mucinous neoplasms Italian patients suffering from mucinous neoplasms will follow a brief interview made by a psychologist. The interview of pilot group will be record to allow us to investigate and track detail that will highlight the comprehension of cancer worry scale an | BEHAVIORAL: Translation and cultural adaptation go the cancer worry scale
|
| : Italian patients with familiarity/genetic predisposition Italian patients with familiarity/genetic predisposition will follow a brief interview made by a psychologist. The interview of pilot group will be record to allow us to investigate and track detail that will highlight the comprehension of cancer worry sc | BEHAVIORAL: Translation and cultural adaptation go the cancer worry scale
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Syntactic and semantic equivalence of Cancer worry scale' items between English and Italian language and vice versa | the Syntactic and semantic equivalence of scale between two languages will be verified through the evaluation of differential item functioning analysis | 1 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Face Validity of cancer worry scale on Italian subjects | Face Validity will be measured through the evaluation of Clarity/ comprehensibility of each item of cancer worry scale (format and meaning) | 6 months |
| Exploratory comparison between Patients Health Questionnaire and Irritability Depression Anxiety Scale and cancer worry scale | the comparison will be done considering the total score of scales | 9 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Salvotore Paiella, MD Phone Number: 0458126669 Email: salvatore.paiella@univr.it |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
