The Emotional Impact of Surveillance for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer, Psychological Distress
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Barratt Simplified Measure of Social Status (BSMSS)
Global Assessment of Functioning scale (GAF)
General Self-Efficacy Scale (GSES)
Perceived Stress Scale (PSS)
Coping Orientation to Problems Experienced (Brief COPE),
Multidimensional Scale of Perceived Social Support (MSPSS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer
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
Sites / Locations
- University Hospital of Verona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psychometric assessment group
Arm Description
Arms to whom the psychometric assessment will be administered
Outcomes
Primary Outcome Measures
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)
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)
Global Assessment of Functioning scale
measure overall levels of functionality of an individual
Global Assessment of Functioning scale
measure overall levels of functionality of an individual
General Self-Efficacy Scale
Self-report scale correlated to emotion, optimism, work
General Self-Efficacy Scale
Self-report scale correlated to emotion, optimism, work
Perceived Stress Scale
Assessment of the perceived stress
Perceived Stress Scale
Assessment of the perceived stress
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
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
Multidimensional Scale of Perceived Social Support
to explore the subject's social support system
Multidimensional Scale of Perceived Social Support
to explore the subject's social support system
Secondary Outcome Measures
Full Information
NCT ID
NCT04024345
First Posted
July 10, 2019
Last Updated
March 30, 2020
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
1. Study Identification
Unique Protocol Identification Number
NCT04024345
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Psychological Distress
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychometric assessment group
Arm Type
Experimental
Arm Description
Arms to whom the psychometric assessment will be administered
Intervention Type
Diagnostic Test
Intervention Name(s)
Barratt Simplified Measure of Social Status (BSMSS)
Intervention Description
Questionnaire that evaluates cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)
Intervention Type
Diagnostic Test
Intervention Name(s)
Global Assessment of Functioning scale (GAF)
Intervention Description
Used to measure overall levels of functionality of an individual
Intervention Type
Diagnostic Test
Intervention Name(s)
General Self-Efficacy Scale (GSES)
Intervention Description
Psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life
Intervention Type
Diagnostic Test
Intervention Name(s)
Perceived Stress Scale (PSS)
Intervention Description
To assess the perceived stress
Intervention Type
Diagnostic Test
Intervention Name(s)
Coping Orientation to Problems Experienced (Brief COPE),
Intervention Description
It evaluates the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations
Intervention Type
Diagnostic Test
Intervention Name(s)
Multidimensional Scale of Perceived Social Support (MSPSS)
Intervention Description
to explore the subject's social support system
Primary Outcome Measure Information:
Title
Barratt Simplified Measure of Social Status
Description
Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)
Time Frame
Baseline
Title
Barratt Simplified Measure of Social Status
Description
Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)
Time Frame
2-years
Title
Global Assessment of Functioning scale
Description
measure overall levels of functionality of an individual
Time Frame
Baseline
Title
Global Assessment of Functioning scale
Description
measure overall levels of functionality of an individual
Time Frame
2-years
Title
General Self-Efficacy Scale
Description
Self-report scale correlated to emotion, optimism, work
Time Frame
Baseline
Title
General Self-Efficacy Scale
Description
Self-report scale correlated to emotion, optimism, work
Time Frame
2-years
Title
Perceived Stress Scale
Description
Assessment of the perceived stress
Time Frame
Baseline
Title
Perceived Stress Scale
Description
Assessment of the perceived stress
Time Frame
2-year
Title
Coping Orientation to Problems Experienced
Description
evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations
Time Frame
Baseline
Title
Coping Orientation to Problems Experienced
Description
evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations
Time Frame
2-years
Title
Multidimensional Scale of Perceived Social Support
Description
to explore the subject's social support system
Time Frame
Baseline
Title
Multidimensional Scale of Perceived Social Support
Description
to explore the subject's social support system
Time Frame
2-years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Hospital of Verona
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20623197
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.
Results Reference
result
PubMed Identifier
27629874
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.
Results Reference
result
PubMed Identifier
21857231
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.
Results Reference
result
PubMed Identifier
26632416
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.
Results Reference
result
PubMed Identifier
30246710
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.
Results Reference
result
PubMed Identifier
30538291
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.
Results Reference
result
Learn more about this trial
The Emotional Impact of Surveillance for Pancreatic Cancer
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