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The Emotional Impact of Surveillance for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04024345
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Erica Secchettin, Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Psychological Distress 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Barratt Simplified Measure of Social Status (BSMSS) [ Time Frame: Baseline ]
    Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)

  2. Barratt Simplified Measure of Social Status (BSMSS) [ Time Frame: 2-years ]
    Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)

  3. Global Assessment of Functioning scale (GAF) [ Time Frame: Baseline ]
    measure overall levels of functionality of an individual

  4. Global Assessment of Functioning scale (GAF) [ Time Frame: 2-years ]
    measure overall levels of functionality of an individual

  5. General Self-Efficacy Scale (GSES) [ Time Frame: Baseline ]
    Self-report scale correlated to emotion, optimism, work

  6. General Self-Efficacy Scale (GSES) [ Time Frame: 2-years ]
    Self-report scale correlated to emotion, optimism, work

  7. Perceived Stress Scale (PSS) [ Time Frame: Baseline ]
    Assessment of the perceived stress

  8. Perceived Stress Scale (PSS) [ Time Frame: 2-year ]
    Assessment of the perceived stress

  9. Coping Orientation to Problems Experienced (Brief COPE) [ 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

  10. Coping Orientation to Problems Experienced (Brief COPE) [ 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

  11. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Baseline ]
    to explore the subject's social support system

  12. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: 2-years ]
    to explore the subject's social support system



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024345


Locations
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Italy
University Hospital of Verona
Verona, VR, Italy, 37134
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona

Publications of Results:

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Responsible Party: Erica Secchettin, Institutional Project Manager, Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT04024345     History of Changes
Other Study ID Numbers: Psy-FPC
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases