The Emotional Impact of Surveillance for Pancreatic Cancer

March 30, 2020 updated by: Erica Secchettin, Azienda Ospedaliera Universitaria Integrata Verona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VR
      • Verona, VR, Italy, 37134
        • University Hospital of Verona

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barratt Simplified Measure of Social Status
Time Frame: Baseline
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
Time Frame: 2-years
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
Time Frame: Baseline
measure overall levels of functionality of an individual
Baseline
Global Assessment of Functioning scale
Time Frame: 2-years
measure overall levels of functionality of an individual
2-years
General Self-Efficacy Scale
Time Frame: Baseline
Self-report scale correlated to emotion, optimism, work
Baseline
General Self-Efficacy Scale
Time Frame: 2-years
Self-report scale correlated to emotion, optimism, work
2-years
Perceived Stress Scale
Time Frame: Baseline
Assessment of the perceived stress
Baseline
Perceived Stress Scale
Time Frame: 2-year
Assessment of the perceived stress
2-year
Coping Orientation to Problems Experienced
Time Frame: Baseline
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
Time Frame: 2-years
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
Time Frame: Baseline
to explore the subject's social support system
Baseline
Multidimensional Scale of Perceived Social Support
Time Frame: 2-years
to explore the subject's social support system
2-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Psy-FPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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