Pancreatic CancerNCT04024345
The Emotional Impact of Surveillance for Pancreatic Cancer
A study testing Barratt Simplified Measure of Social Status (BSMSS), Global Assessment of Functioning scale (GAF) and General Self-Efficacy Scale (GSES) in people with Pancreatic Cancer and Psychological Distress, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Psychological Distress
- What is being tested?
- Barratt Simplified Measure of Social Status (BSMSS), Global Assessment of Functioning scale (GAF) and General Self-Efficacy Scale (GSES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being enrolled in the Institutional surveillance program for pancreatic cancer
- Ability to understand the details and implications of a study protocol.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact
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.
- Conditions
- Pancreatic Cancer, Psychological Distress
- Being tested
- 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),
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Global Assessment of Functioning scale (GAF)Diagnostic test
Used to measure overall levels of functionality of an individual
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
Perceived Stress Scale (PSS)Diagnostic test
To assess the perceived stress
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
Multidimensional Scale of Perceived Social Support (MSPSS)Diagnostic test
to explore the subject's social support system
| Study group | Role | What they receive |
|---|---|---|
| Psychometric assessment group | Experimental | Arms to whom the psychometric assessment will be administered Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 2-years
Global Assessment of Functioning scale
measure overall levels of functionality of an individual
Measured: Baseline
Global Assessment of Functioning scale
measure overall levels of functionality of an individual
Measured: 2-years
General Self-Efficacy Scale
Self-report scale correlated to emotion, optimism, work
Measured: Baseline
General Self-Efficacy Scale
Self-report scale correlated to emotion, optimism, work
Measured: 2-years
Perceived Stress Scale
Assessment of the perceived stress
Measured: Baseline
Perceived Stress Scale
Assessment of the perceived stress
Measured: 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
Measured: 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
Measured: 2-years
Multidimensional Scale of Perceived Social Support
to explore the subject's social support system
Measured: Baseline
Multidimensional Scale of Perceived Social Support
to explore the subject's social support system
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jul 2017
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Secchettin, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024345
- Sponsor's protocol ID
- Psy-FPC
- Status last verified
- Mar 2020
- First submitted
- 10 Jul 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20623197Konings 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.
PubMed 27629874Harinck 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.
PubMed 21857231Konings 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.
PubMed 26632416Cazacu 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.
PubMed 30246710Paiella 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.
PubMed 30538291
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Program in High-risk Individuals for Pancreatic Cancer: Prospective Analysis of the Emotional Impact
- ClinicalTrials.gov ID
- NCT04024345
- Acronym / sponsor ID
- Psy-FPC
- Conditions
- Pancreatic Cancer, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychometric assessment group | Experimental | 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)Arms to whom the psychometric assessment will be administered |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Being enrolled in the Institutional surveillance program for pancreatic cancer
- Ability to understand the details and implications of a study protocol.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Psychometric assessment group |
| Global Assessment of Functioning scale (GAF)Used to measure overall levels of functionality of an individual | Diagnostic test | Psychometric assessment group |
| 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 | Psychometric assessment group |
| Perceived Stress Scale (PSS)To assess the perceived stress | Diagnostic test | Psychometric assessment group |
| 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 | Psychometric assessment group |
| Multidimensional Scale of Perceived Social Support (MSPSS)to explore the subject's social support system | Diagnostic test | Psychometric assessment group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Results publication: PubMed 20623197Maheu 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 publication: PubMed 27629874Konings 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 publication: PubMed 21857231Harinck 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 publication: PubMed 26632416Konings 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 publication: PubMed 30246710Cazacu 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 publication: PubMed 30538291Paiella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barratt Simplified Measure of Social Status (BSMSS), Global Assessment of Functioning scale (GAF) and General Self-Efficacy Scale (GSES) in people with Pancreatic Cancer and Psychological Distress, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barratt Simplified Measure of Social Status (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024345, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.