The Emotional Impact of Surveillance for Pancreatic Cancer
NCT ID: NCT04024345
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2017-07-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Psychometric assessment group
Arms to whom the psychometric assessment will be administered
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)
Global Assessment of Functioning scale (GAF)
Used to measure overall levels of functionality of an individual
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
Perceived Stress Scale (PSS)
To assess the perceived stress
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
Multidimensional Scale of Perceived Social Support (MSPSS)
to explore the subject's social support system
Interventions
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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)
Global Assessment of Functioning scale (GAF)
Used to measure overall levels of functionality of an individual
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
Perceived Stress Scale (PSS)
To assess the perceived stress
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
Multidimensional Scale of Perceived Social Support (MSPSS)
to explore the subject's social support system
Eligibility Criteria
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Inclusion Criteria
* Ability to understand the details and implications of a study protocol.
Exclusion Criteria
ALL
Yes
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Erica Secchettin
Institutional Project Manager
Locations
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University Hospital of Verona
Verona, VR, Italy
Countries
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References
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Maheu C, Vodermaier A, Rothenmund H, Gallinger S, Ardiles P, Semotiuk K, Holter S, Thayalan S, Esplen MJ. Pancreatic cancer risk counselling and screening: impact on perceived risk and psychological functioning. Fam Cancer. 2010 Dec;9(4):617-24. doi: 10.1007/s10689-010-9354-5.
Konings IC, Harinck F, Kuenen MA, Sidharta GN, Kieffer JM, Aalfs CM, Poley JW, Smets EM, Wagner A, van Rens A, Vleggaar FP, Ausems MG, Fockens P, van Hooft JE, Bruno MJ, Bleiker EM; Dutch research group on pancreatic cancer surveillance in high-risk individuals. Factors associated with cancer worries in individuals participating in annual pancreatic cancer surveillance. Fam Cancer. 2017 Jan;16(1):143-151. doi: 10.1007/s10689-016-9930-4.
Harinck F, Nagtegaal T, Kluijt I, Aalfs C, Smets E, Poley JW, Wagner A, van Hooft J, Fockens P, Bruno M, Bleiker EM. Feasibility of a pancreatic cancer surveillance program from a psychological point of view. Genet Med. 2011 Dec;13(12):1015-24. doi: 10.1097/GIM.0b013e31822934f5.
Konings IC, Sidharta GN, Harinck F, Aalfs CM, Poley JW, Kieffer JM, Kuenen MA, Smets EM, Wagner A, van Hooft JE, van Rens A, Fockens P, Bruno MJ, Bleiker EM. Repeated participation in pancreatic cancer surveillance by high-risk individuals imposes low psychological burden. Psychooncology. 2016 Aug;25(8):971-8. doi: 10.1002/pon.4047. Epub 2015 Dec 3.
Cazacu IM, Luzuriaga Chavez AA, Saftoiu A, Bhutani MS. Psychological impact of pancreatic cancer screening by EUS or magnetic resonance imaging in high-risk individuals: A systematic review. Endosc Ultrasound. 2019 Jan-Feb;8(1):17-24. doi: 10.4103/eus.eus_25_18.
Paiella S, Capurso G, Cavestro GM, Butturini G, Pezzilli R, Salvia R, Signoretti M, Crippa S, Carrara S, Frigerio I, Bassi C, Falconi M, Iannicelli E, Giardino A, Mannucci A, Laghi A, Laghi L, Frulloni L, Zerbi A. Results of First-Round of Surveillance in Individuals at High-Risk of Pancreatic Cancer from the AISP (Italian Association for the Study of the Pancreas) Registry. Am J Gastroenterol. 2019 Apr;114(4):665-670. doi: 10.1038/s41395-018-0414-z.
Other Identifiers
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Psy-FPC
Identifier Type: -
Identifier Source: org_study_id
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