Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)
NCT ID: NCT04396093
Last Updated: 2020-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2020-02-10
2021-05-10
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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psychological support
specific questionnaires administration: EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory
Eligibility Criteria
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Inclusion Criteria
* Patients candidated to receive an active treatment (surgery, chemiotherapy, chemio-radiation)
* Patients able to sign the informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Michele Reni
OTHER
Responsible Party
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Michele Reni
MD
Principal Investigators
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Michele Reni, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele
Locations
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IRCCS S Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Angelino 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.
Brunault 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.
Champagne 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.
Fitzsimmons 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.
Fras 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.
Green 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.
Gupta 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.
Kelsen 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.
Passik 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.
Other Identifiers
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PACT24
Identifier Type: -
Identifier Source: org_study_id
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