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2017-07-01
2021-07-31
2021-12-31
150
NCT04024345
Azienda Ospedaliera Universitaria Integrata Verona
Azienda Ospedaliera Universitaria Integrata Verona
INTERVENTIONAL
The Emotional Impact of Surveillance for Pancreatic Cancer
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.
N/A
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 |
|---|---|---|
2019-07-10 | N/A | 2020-03-30 |
2019-07-16 | N/A | 2020-03-31 |
2019-07-18 | N/A | 2020-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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)
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)
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
Accepts Healthy Volunteers:
1
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
