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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychometric assessment group | Experimental | Arms to whom the psychometric assessment will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barratt Simplified Measure of Social Status (BSMSS) | Diagnostic Test | Questionnaire that evaluates cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Verona | Verona | VR | 37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20623197 | Result | 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. | |
| 27629874 | Result | 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. |
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| Global Assessment of Functioning scale (GAF) | Diagnostic Test | Used to measure overall levels of functionality of an individual |
|
| General Self-Efficacy Scale (GSES) | Diagnostic Test | Psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life |
|
| Perceived Stress Scale (PSS) | Diagnostic Test | To assess the perceived stress |
|
| Coping Orientation to Problems Experienced (Brief COPE), | Diagnostic Test | 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) | Diagnostic Test | to explore the subject's social support system |
|
| 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 |
| 21857231 | Result | 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. |
| 26632416 | Result | 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. |
| 30246710 | Result | 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. |
| 30538291 | Result | 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. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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