Clinical trial NCT04024345: The Emotional Impact of Surveillance for Pancreatic Cancer
Official title: Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Psychological Distress
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Barratt Simplified Measure of Social Status
timeFrame: Baseline
measure: Barratt Simplified Measure of Social Status
timeFrame: 2-years
measure: Global Assessment of Functioning scale
timeFrame: Baseline
measure: Global Assessment of Functioning scale
timeFrame: 2-years
measure: General Self-Efficacy Scale
timeFrame: Baseline
measure: General Self-Efficacy Scale
timeFrame: 2-years
measure: Perceived Stress Scale
timeFrame: Baseline
measure: Perceived Stress Scale
timeFrame: 2-year
measure: Coping Orientation to Problems Experienced
timeFrame: Baseline
measure: Coping Orientation to Problems Experienced
timeFrame: 2-years
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline
measure: Multidimensional Scale of Perceived Social Support
timeFrame: 2-years
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University Hospital of Verona
state: VR
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.