The Emotional Impact of Surveillance for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04024345
• Other study ID #: Psy-FPC
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Psychological Distress

Intervention

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)
• 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

Locations

Country	Name	City	State
Italy	University Hospital of Verona	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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 — View 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: 10.10 — View 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 indiv — View 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 psy — View 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: 10.1 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Global Assessment of Functioning scale	measure overall levels of functionality of an individual	Baseline
Primary	Global Assessment of Functioning scale	measure overall levels of functionality of an individual	2-years
Primary	General Self-Efficacy Scale	Self-report scale correlated to emotion, optimism, work	Baseline
Primary	General Self-Efficacy Scale	Self-report scale correlated to emotion, optimism, work	2-years
Primary	Perceived Stress Scale	Assessment of the perceived stress	Baseline
Primary	Perceived Stress Scale	Assessment of the perceived stress	2-year
Primary	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
Primary	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
Primary	Multidimensional Scale of Perceived Social Support	to explore the subject's social support system	Baseline
Primary	Multidimensional Scale of Perceived Social Support	to explore the subject's social support system	2-years