The Italian Version of Cancer Worry Scale

Pancreatic Cancer Clinical Trial

— CWS_Ita  

Official title:

The Italian Version of the Cancer Worry Scale . A Pancreatic Context Adaptation and Reliability Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04318756
• Other study ID #: 2458 CWS
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2020
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Salvotore Paiella, MD
• Phone: 0458126669
• Email: salvatore.paiella[@]univr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subject will be recruited from the current outpatients' clinic activity of the General and Pancreatic Surgery Unit, Pancreas Institute, Verona University Hospital. Subjects must be able to read and write in Italian. After obtained informed consent we will ask them to participate to preliminary pilot phase.

The interview of the pilot group will be audio recorded to allow to investigate and track detail that will highlight the comprehension of scale and participants' suggestion.

Patients affected by cynic neoplasm (group A) and high risk subjects for familiarity/genetic predisposition (group B) are currently enrolled at General and Pancreatic Surgery Unit of the Pancreas Institute of the University of Verona.

Group A Patients with premalignant lesions (such as intraductal papillary mucinous neoplasms) that are followed-up at our Institution, to detect any clinic-radiological progression. Subjects older than 18 will be enrolled.

Group B

The enrolment criteria were the following :

• Having at least 45 years of age or 10 years younger than the age of the youngest relative with pancreatic cancer (only for subject with familiar history of pancreatic cancer)

• Having at least 40 years of age or 5 years younger than the age of the youngest relative with pancreatic cancer (only for subject with familial pancreatitis and subject affected by Lynch syndrome with at least one relative first- or second-degree affected by pancreatic cancer and subject having a known genetic mutation with at least a first-degree relative or a second-degree relative affected by pancreatic cancer

• Having at least 30 years of age for subject with Familial Multiple Melanoma Syndrome

• Having at least 30 years of age for patients affected by Peutz-Jeghers syndrome.

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 and participants' suggestion.

Exclusion Criteria:

• patients who not meet eligibility criteria

Related Conditions & MeSH terms

• Cancer Fear
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Translation and cultural adaptation go the cancer worry scale
To develop and validate the Italian version of Cancer worry scale using high risk subjects for familiarity/genetic predisposition and patients with premalignant lesions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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