Pancreas AdenocarcinomaNCT04396093
Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)
An observational study of Pancreas Adenocarcinoma, run by Michele Reni at 1 site in Italy.
Trial summary
The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma
- What is being tested?
- psychological support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2020to 10 May 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a confirmed diagnosis of pancreatic ductal adenocarcinoma (resectable, borderline resectable, locally advanced or metastatic)
Who may be able to join
- Patients older than 18 years
- Patients candidated to receive an active treatment (surgery, chemiotherapy, chemio-radiation)
- Patients able to sign the informed consent.
Who cannot join
- • Patients with a school education level less than 8 years, since the complexity of submitted questionnaires.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS S Raffaele
Milan, 20132
Giulia Bruna Delli Zotti, +39 02 26436173, dellizotti.giuliabruna@hsr.it
Maria Maddalena Valente, +39 02 26437623, valente.mariamaddalena@hsr.it
About this study
Official title: Analysis of Anxiety-depressive Patterns, Quality of Life and Personality Assessment in Patients With Pancreatic Cancer: Outcome of Adaptation to Disease and Clinical Treatments
The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery
Read the detailed description
Pancreatic cancer is an aggressive disease whose prognosis is generally unfavorable: less than 20% of patients results eligible for resection treatment with potentially curative purposes and only in 2019 in Italy 13,500 new cases were estimated. It represents one of the poorest prognosis with 8.1% survival at 5 years and 3% at 10 years.
Its treatments can have a negative effect on the quality of life linked to the health of patients (HRQoL). Over the past 20 years, the quality of life assessment has become an important component of evaluating new therapeutic approaches, providing indications on the patient's perception of the benefits of the treatments to which he undergoes. Therefore, an accurate assessment of HRQoL using valid and standardized tools is crucial to highlight the costs and benefits of the different therapeutic options and the clinical utility of the data.
Description of the intervention (schedule of visits):
Visit 1 (screening). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and all questionnaires will be administered EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory).
Enrolled patients will make a first psychological visit within one month of the initial diagnosis and before starting active medical treatment (chemotherapy, radiochemotherapy, surgery). During this visit, they will be asked to complete questionnaires aimed at assessing the quality of life (EORCT QLQ 30, EORCT PAN26) of the anxiety-depressant aspects related to the disease (HADS) and of the personological functioning (MCMI-III) to proceed psychological evaluation.
During the visit 2 (2-3 months after the first dose of planned chemotherapy and following an instrumental re-evaluation), the quality of life and the anxiety-depression symptoms related to the disease will be re-evaluated (EORCT QLQ 30, EORCT PAN26; HADS)
The researcher will record in a dedicated database all patient information, such as:
- Personal data (gender, age, schooling)
- Onset and related timing of anxiety disorders or mood before the disease onset
- Psychological or psychiatric visits before the disease onset
- Psychotropic drugs use/abuse
- Psychotherapeutic or psychological path in progress
- Family, social, religious /spiritual resources
- Eligibility for surgery
- Stage of illness
- Clinical treatment (type of chemotherapy, radiochemotherapy)
- Therapeutic result (response, progression stability)
- Any serious adverse events (SAE).
The same variables recorded at Visit 1 will be checked again.
Power size calculation:
The number of patients was calculated taking into account the main outcome. Assuming a positive correlation coefficient of 0.3 (effect size) between the change in anxiety depression levels and self-perceived quality of life, an 85% power, a 5% significance level and a drop-out percentage / missing data equal to 30%, it is estimated a sample size of 75 patients.
- Conditions
- Pancreas Adenocarcinoma
- Being tested
- psychological support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological supportBehavioural
specific questionnaires administration: EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the anxiety and depression in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
The prevalence and variations of the anxious and depressive symptoms related to the disease condition (HADS questionnaire) during the disease course
Measured: 12 weeks after the diagnosis
Analysis of the quality of life in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
The quality of life self-perceived by the patient (EORTC QLQ 30 - PAN 26 questionnaires) and its variations during the disease path
Measured: 12 weeks after the diagnosis
Secondary outcomes (1)
The influence of patient personality on chemioterapic treatment response
The influence of a maladaptive personality profiles and psychopathological aspects vs adaptive personality profiles and absence of disease psychopathological aspects (Millon Cutt off <75) on the quality of self-perceived life (EORTC QLQ 30 questionnaire) and on disease-related anxiety-depressive symptoms (HADS questionnaire) during the treatment through a psychodiagnostic assessment
Measured: 12 weeks after the diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start10 Feb 2020
- Primary completion10 May 2021 (estimated)
- Study completion10 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pancreas AdenocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michele Reni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele Reni, IRCCS San Raffaele
- Investigators
- Michele Reni, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396093
- Sponsor's protocol ID
- PACT24
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Angelino AF, Treisman GJ. Major depression and demoralization in cancer patients: diagnostic and treatment considerations. Support Care Cancer. 2001 Jul;9(5):344-9. doi: 10.1007/s005200000195.
PubMed 11497387Brunault P, Champagne AL, Huguet G, Suzanne I, Senon JL, Body G, Rusch E, Magnin G, Voyer M, Reveillere C, Camus V. Major depressive disorder, personality disorders, and coping strategies are independent risk factors for lower quality of life in non-metastatic breast cancer patients. Psychooncology. 2016 May;25(5):513-20. doi: 10.1002/pon.3947. Epub 2015 Sep 10.
PubMed 26356037Champagne AL, Brunault P, Huguet G, Suzanne I, Senon JL, Body G, Rusch E, Magnin G, Voyer M, Reveillere C, Camus V. Personality disorders, but not cancer severity or treatment type, are risk factors for later generalised anxiety disorder and major depressive disorder in non metastatic breast cancer patients. Psychiatry Res. 2016 Feb 28;236:64-70. doi: 10.1016/j.psychres.2015.12.032. Epub 2015 Dec 25.
PubMed 26747215Fitzsimmons D, Johnson CD, George S, Payne S, Sandberg AA, Bassi C, Beger HG, Birk D, Buchler MW, Dervenis C, Fernandez Cruz L, Friess H, Grahm AL, Jeekel J, Laugier R, Meyer D, Singer MW, Tihanyi T. Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life. Eur J Cancer. 1999 Jun;35(6):939-41. doi: 10.1016/s0959-8049(99)00047-7.
PubMed 10533475Fras I, Litin EM, Bartholomew LG. Mental symptoms as an aid in the early diagnosis of carcinoma of the pancreas. Gastroenterology. 1968 Aug;55(2):191-8. No abstract available.
PubMed 4385690Green AI, Austin CP. Psychopathology of pancreatic cancer. A psychobiologic probe. Psychosomatics. 1993 May-Jun;34(3):208-21. doi: 10.1016/S0033-3182(93)71882-4.
PubMed 8493302Gupta D, Lis CG, Grutsch JF. The European organization for research and treatment of cancer quality of life questionnaire: implications for prognosis in pancreatic cancer. Int J Gastrointest Cancer. 2006;37(2-3):65-73. doi: 10.1007/s12029-007-0001-9.
PubMed 17827524Kelsen DP, Portenoy RK, Thaler HT, Niedzwiecki D, Passik SD, Tao Y, Banks W, Brennan MF, Foley KM. Pain and depression in patients with newly diagnosed pancreas cancer. J Clin Oncol. 1995 Mar;13(3):748-55. doi: 10.1200/JCO.1995.13.3.748.
PubMed 7884435Passik SD, Roth AJ. Anxiety symptoms and panic attacks preceding pancreatic cancer diagnosis. Psychooncology. 1999 May-Jun;8(3):268-72. doi: 10.1002/(SICI)1099-1611(199905/06)8:33.0.CO;2-W.
PubMed 10390740
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Anxiety-depressive Patterns, Quality of Life and Personality Assessment in Patients With Pancreatic Cancer: Outcome of Adaptation to Disease and Clinical Treatments
- ClinicalTrials.gov ID
- NCT04396093
- Acronym / sponsor ID
- PACT24
- Conditions
- Pancreas Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Michele ReniUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 10 May 2021 (estimated)
- First posted
- 20 May 2020 (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.
The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery
Detailed description
Pancreatic cancer is an aggressive disease whose prognosis is generally unfavorable: less than 20% of patients results eligible for resection treatment with potentially curative purposes and only in 2019 in Italy 13,500 new cases were estimated. It represents one of the poorest prognosis with 8.1% survival at 5 years and 3% at 10 years.
Its treatments can have a negative effect on the quality of life linked to the health of patients (HRQoL). Over the past 20 years, the quality of life assessment has become an important component of evaluating new therapeutic approaches, providing indications on the patient's perception of the benefits of the treatments to which he undergoes. Therefore, an accurate assessment of HRQoL using valid and standardized tools is crucial to highlight the costs and benefits of the different therapeutic options and the clinical utility of the data.
Description of the intervention (schedule of visits):
Visit 1 (screening). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and all questionnaires will be administered EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory).
Enrolled patients will make a first psychological visit within one month of the initial diagnosis and before starting active medical treatment (chemotherapy, radiochemotherapy, surgery). During this visit, they will be asked to complete questionnaires aimed at assessing the quality of life (EORCT QLQ 30, EORCT PAN26) of the anxiety-depressant aspects related to the disease (HADS) and of the personological functioning (MCMI-III) to proceed psychological evaluation.
During the visit 2 (2-3 months after the first dose of planned chemotherapy and following an instrumental re-evaluation), the quality of life and the anxiety-depression symptoms related to the disease will be re-evaluated (EORCT QLQ 30, EORCT PAN26; HADS)
The researcher will record in a dedicated database all patient information, such as:
- Personal data (gender, age, schooling)
- Onset and related timing of anxiety disorders or mood before the disease onset
- Psychological or psychiatric visits before the disease onset
- Psychotropic drugs use/abuse
- Psychotherapeutic or psychological path in progress
- Family, social, religious /spiritual resources
- Eligibility for surgery
- Stage of illness
- Clinical treatment (type of chemotherapy, radiochemotherapy)
- Therapeutic result (response, progression stability)
- Any serious adverse events (SAE).
The same variables recorded at Visit 1 will be checked again.
Power size calculation:
The number of patients was calculated taking into account the main outcome. Assuming a positive correlation coefficient of 0.3 (effect size) between the change in anxiety depression levels and self-perceived quality of life, an 85% power, a 5% significance level and a drop-out percentage / missing data equal to 30%, it is estimated a sample size of 75 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a confirmed diagnosis of pancreatic ductal adenocarcinoma (resectable, borderline resectable, locally advanced or metastatic)
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients candidated to receive an active treatment (surgery, chemiotherapy, chemio-radiation)
- Patients able to sign the informed consent.
Key exclusion criteria (1 listed)
- • Patients with a school education level less than 8 years, since the complexity of submitted questionnaires.
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 |
|---|---|---|
| psychological supportspecific questionnaires administration: EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory | Behavioural | – |
Primary outcome
Analysis of the anxiety and depression in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
Time frame: 12 weeks after the diagnosis
The prevalence and variations of the anxious and depressive symptoms related to the disease condition (HADS questionnaire) during the disease course
Analysis of the quality of life in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
Time frame: 12 weeks after the diagnosis
The quality of life self-perceived by the patient (EORTC QLQ 30 - PAN 26 questionnaires) and its variations during the disease path
1 secondary outcome
The influence of patient personality on chemioterapic treatment response
Time frame: 12 weeks after the diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 11497387Angelino AF, Treisman GJ. Major depression and demoralization in cancer patients: diagnostic and treatment considerations. Support Care Cancer. 2001 Jul;9(5):344-9. doi: 10.1007/s005200000195.
- Background: PubMed 26356037Brunault P, Champagne AL, Huguet G, Suzanne I, Senon JL, Body G, Rusch E, Magnin G, Voyer M, Reveillere C, Camus V. Major depressive disorder, personality disorders, and coping strategies are independent risk factors for lower quality of life in non-metastatic breast cancer patients. Psychooncology. 2016 May;25(5):513-20. doi: 10.1002/pon.3947. Epub 2015 Sep 10.
- Background: PubMed 26747215Champagne AL, Brunault P, Huguet G, Suzanne I, Senon JL, Body G, Rusch E, Magnin G, Voyer M, Reveillere C, Camus V. Personality disorders, but not cancer severity or treatment type, are risk factors for later generalised anxiety disorder and major depressive disorder in non metastatic breast cancer patients. Psychiatry Res. 2016 Feb 28;236:64-70. doi: 10.1016/j.psychres.2015.12.032. Epub 2015 Dec 25.
- Background: PubMed 10533475Fitzsimmons D, Johnson CD, George S, Payne S, Sandberg AA, Bassi C, Beger HG, Birk D, Buchler MW, Dervenis C, Fernandez Cruz L, Friess H, Grahm AL, Jeekel J, Laugier R, Meyer D, Singer MW, Tihanyi T. Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life. Eur J Cancer. 1999 Jun;35(6):939-41. doi: 10.1016/s0959-8049(99)00047-7.
- Background: PubMed 4385690Fras I, Litin EM, Bartholomew LG. Mental symptoms as an aid in the early diagnosis of carcinoma of the pancreas. Gastroenterology. 1968 Aug;55(2):191-8. No abstract available.
- Background: PubMed 8493302Green AI, Austin CP. Psychopathology of pancreatic cancer. A psychobiologic probe. Psychosomatics. 1993 May-Jun;34(3):208-21. doi: 10.1016/S0033-3182(93)71882-4.
- Background: PubMed 17827524Gupta D, Lis CG, Grutsch JF. The European organization for research and treatment of cancer quality of life questionnaire: implications for prognosis in pancreatic cancer. Int J Gastrointest Cancer. 2006;37(2-3):65-73. doi: 10.1007/s12029-007-0001-9.
- Background: PubMed 7884435Kelsen DP, Portenoy RK, Thaler HT, Niedzwiecki D, Passik SD, Tao Y, Banks W, Brennan MF, Foley KM. Pain and depression in patients with newly diagnosed pancreas cancer. J Clin Oncol. 1995 Mar;13(3):748-55. doi: 10.1200/JCO.1995.13.3.748.
- Background: PubMed 10390740Passik SD, Roth AJ. Anxiety symptoms and panic attacks preceding pancreatic cancer diagnosis. Psychooncology. 1999 May-Jun;8(3):268-72. doi: 10.1002/(SICI)1099-1611(199905/06)8:33.0.CO;2-W.
- Individual participant dataSharing planned: Undecided
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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.
Michele Reni, MD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma, run by Michele Reni 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 3 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 20 May 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?
Contact Giulia Bruna Delli Zotti (+390226436173, dellizotti.giuliabruna@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the anxiety and depression in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery) (time frame: 12 weeks after the diagnosis). The study lists 2 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 NCT04396093, which also lists 10 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 20 May 2020.