NCT04024345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

4.1 years

First QC Date

July 10, 2019

Last Update Submit

March 30, 2020

Conditions

Pancreatic CancerPsychological Distress

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (1)

Psychometric assessment group

EXPERIMENTAL

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)

Interventions

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)

Psychometric assessment group
Global Assessment of Functioning scale (GAF)DIAGNOSTIC_TEST

Used to measure overall levels of functionality of an individual

Psychometric assessment group
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

Psychometric assessment group
Perceived Stress Scale (PSS)DIAGNOSTIC_TEST

To assess the perceived stress

Psychometric assessment group
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

Psychometric assessment group
Multidimensional Scale of Perceived Social Support (MSPSS)DIAGNOSTIC_TEST

to explore the subject's social support system

Psychometric assessment group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being enrolled in the Institutional surveillance program for pancreatic cancer
  • Ability to understand the details and implications of a study protocol.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Verona

Verona, VR, 37134, Italy

Location

Related Publications (6)

  • 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.

    PMID: 20623197RESULT

  • 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.

    PMID: 27629874RESULT

  • 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.

    PMID: 21857231RESULT

  • 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.

    PMID: 26632416RESULT

  • 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.

    PMID: 30246710RESULT

  • 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.

    PMID: 30538291RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institutional Project Manager

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 18, 2019

Study Start

July 1, 2017

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)