The Emotional Impact of Surveillance for Pancreatic Cancer

Study Overview
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Brief Summary
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Due to its rarity a population screening program for pancreatic cancer is not possible. For this reason, considering background data on genetic predisposition and familiarity for this lethal tumor, efforts have been pushed to build up surveillance programs for subjects at high-risk of pancreatic cancer, due to familiarity and/or genetic predisposition. These programs are based on radiological examinations (such as MRI or endoultrasonography) and laboratory tests. However, little is known about the psychological burden of these programs. Only a handful of studies investigated, in various ways, how the participation in surveillance programs for pancreatic cancer may burden the psychological status, with a consequent possible impairment of the psychological wellbeing, and a higher risk of withdraw from the surveillance program itself. The aim of this study was to assess the psychological and emotional impact in high-risk individuals participating in a surveillance program for pancreatic cancer due to familiarity and/or to genetic predisposition, using specific psychological tools, such as multiple psychological questionnaires, investigating different functioning areas, administered by a clinical psychologist.

Official Title
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Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact

Conditions
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Pancreatic Cancer, Psychological Distress

Intervention / Treatment
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* Diagnostic Test: Barratt Simplified Measure of Social Status (BSMSS)
* Diagnostic Test: Global Assessment of Functioning scale (GAF)
* Diagnostic Test: General Self-Efficacy Scale (GSES)
* Diagnostic Test: Perceived Stress Scale (PSS)
* Diagnostic Test: Coping Orientation to Problems Experienced (Brief COPE),
* Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being enrolled in the Institutional surveillance program for pancreatic cancer Ability to understand the details and implications of a study protocol. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychometric assessment group<br>Arms to whom the psychometric assessment will be administered | Diagnostic Test: Barratt Simplified Measure of Social Status (BSMSS)<br>* Questionnaire that evaluates cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)<br>Diagnostic Test: Global Assessment of Functioning scale (GAF)<br>* Used to measure overall levels of functionality of an individual<br>Diagnostic Test: General Self-Efficacy Scale (GSES)<br>* Psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life<br>Diagnostic Test: Perceived Stress Scale (PSS)<br>* To assess the perceived stress<br>Diagnostic Test: Coping Orientation to Problems Experienced (Brief COPE),<br>* It evaluates the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations<br>Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS)<br>* to explore the subject's social support system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barratt Simplified Measure of Social Status | Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any) | Baseline | 
| Barratt Simplified Measure of Social Status | Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any) | 2-years | 
| Global Assessment of Functioning scale | measure overall levels of functionality of an individual | Baseline | 
| Global Assessment of Functioning scale | measure overall levels of functionality of an individual | 2-years | 
| General Self-Efficacy Scale | Self-report scale correlated to emotion, optimism, work | Baseline | 
| General Self-Efficacy Scale | Self-report scale correlated to emotion, optimism, work | 2-years | 
| Perceived Stress Scale | Assessment of the perceived stress | Baseline | 
| Perceived Stress Scale | Assessment of the perceived stress | 2-year | 
| Coping Orientation to Problems Experienced | evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations | Baseline | 
| Coping Orientation to Problems Experienced | evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations | 2-years | 
| Multidimensional Scale of Perceived Social Support | to explore the subject's social support system | Baseline | 
| Multidimensional Scale of Perceived Social Support | to explore the subject's social support system | 2-years |