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出境医 / 临床实验 / The Emotional Impact of Surveillance for Pancreatic Cancer

The Emotional Impact of Surveillance for Pancreatic Cancer

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Psychological Distress 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) Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Psychometric assessment group
Arms to whom the psychometric assessment will be administered
 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)

Diagnostic Test: Global Assessment of Functioning scale (GAF)
Used to measure overall levels of functionality of an individual

Diagnostic Test: 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

Diagnostic Test: Perceived Stress Scale (PSS)
To assess the perceived stress

Diagnostic Test: 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

Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS)
to explore the subject's social support system
Outcome Measures
Primary Outcome Measures :
  1. Barratt Simplified Measure of Social Status [ Time Frame: Baseline ]
    Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)

  2. Barratt Simplified Measure of Social Status [ Time Frame: 2-years ]
    Evaluation of cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)

  3. Global Assessment of Functioning scale [ Time Frame: Baseline ]
    measure overall levels of functionality of an individual

  4. Global Assessment of Functioning scale [ Time Frame: 2-years ]
    measure overall levels of functionality of an individual

  5. General Self-Efficacy Scale [ Time Frame: Baseline ]
    Self-report scale correlated to emotion, optimism, work

  6. General Self-Efficacy Scale [ Time Frame: 2-years ]
    Self-report scale correlated to emotion, optimism, work

  7. Perceived Stress Scale [ Time Frame: Baseline ]
    Assessment of the perceived stress

  8. Perceived Stress Scale [ Time Frame: 2-year ]
    Assessment of the perceived stress

  9. Coping Orientation to Problems Experienced [ Time Frame: Baseline ]
    evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations

  10. Coping Orientation to Problems Experienced [ Time Frame: 2-years ]
    evaluation of the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations

  11. Multidimensional Scale of Perceived Social Support [ Time Frame: Baseline ]
    to explore the subject's social support system

  12. Multidimensional Scale of Perceived Social Support [ Time Frame: 2-years ]
    to explore the subject's social support system


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Italy
University Hospital of Verona
Verona, VR, Italy, 37134
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Barratt Simplified Measure of Social Status [ Time Frame: Baseline ]
    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 [ Time Frame: 2-years ]
    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 [ Time Frame: Baseline ]
    measure overall levels of functionality of an individual
  • Global Assessment of Functioning scale [ Time Frame: 2-years ]
    measure overall levels of functionality of an individual
  • General Self-Efficacy Scale [ Time Frame: Baseline ]
    Self-report scale correlated to emotion, optimism, work
  • General Self-Efficacy Scale [ Time Frame: 2-years ]
    Self-report scale correlated to emotion, optimism, work
  • Perceived Stress Scale [ Time Frame: Baseline ]
    Assessment of the perceived stress
  • Perceived Stress Scale [ Time Frame: 2-year ]
    Assessment of the perceived stress
  • Coping Orientation to Problems Experienced [ Time Frame: Baseline ]
    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 [ Time Frame: 2-years ]
    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 [ Time Frame: Baseline ]
    to explore the subject's social support system
  • Multidimensional Scale of Perceived Social Support [ Time Frame: 2-years ]
    to explore the subject's social support system
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Barratt Simplified Measure of Social Status (BSMSS) [ Time Frame: Baseline ]
    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 (BSMSS) [ Time Frame: 2-years ]
    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 (GAF) [ Time Frame: Baseline ]
    measure overall levels of functionality of an individual
  • Global Assessment of Functioning scale (GAF) [ Time Frame: 2-years ]
    measure overall levels of functionality of an individual
  • General Self-Efficacy Scale (GSES) [ Time Frame: Baseline ]
    Self-report scale correlated to emotion, optimism, work
  • General Self-Efficacy Scale (GSES) [ Time Frame: 2-years ]
    Self-report scale correlated to emotion, optimism, work
  • Perceived Stress Scale (PSS) [ Time Frame: Baseline ]
    Assessment of the perceived stress
  • Perceived Stress Scale (PSS) [ Time Frame: 2-year ]
    Assessment of the perceived stress
  • Coping Orientation to Problems Experienced (Brief COPE) [ Time Frame: Baseline ]
    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 (Brief COPE) [ Time Frame: 2-years ]
    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 (MSPSS) [ Time Frame: Baseline ]
    to explore the subject's social support system
  • Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: 2-years ]
    to explore the subject's social support system
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Emotional Impact of Surveillance for Pancreatic Cancer
Official Title  ICMJE Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pancreatic Cancer
  • Psychological Distress
Intervention  ICMJE
  • 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)
  • Diagnostic Test: Global Assessment of Functioning scale (GAF)
    Used to measure overall levels of functionality of an individual
  • Diagnostic Test: 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
  • Diagnostic Test: Perceived Stress Scale (PSS)
    To assess the perceived stress
  • Diagnostic Test: 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
  • Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS)
    to explore the subject's social support system
Study Arms  ICMJE Experimental: Psychometric assessment group
Arms to whom the psychometric assessment will be administered
Interventions:
  • 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)
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2019) 		150
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024345
Other Study ID Numbers  ICMJE Psy-FPC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erica Secchettin, Azienda Ospedaliera Universitaria Integrata Verona
Study Sponsor  ICMJE Azienda Ospedaliera Universitaria Integrata Verona
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliera Universitaria Integrata Verona
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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