Analysis Of The Anxiety-Depressive Pattern, Quality Of Life And Assessment Of Personality in Patients With Pancreatic Ductal Adenocarcinoma (PACT24)

NCT04396093 | Unknown

• 1 other identifier: PACT24
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreas Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 weeks after the diagnosis

Secondary Outcomes (1)

• The influence of patient personality on chemioterapic treatment response

  12 weeks after the diagnosis

Interventions

psychological support BEHAVIORAL

specific questionnaires administration: EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a confirmed diagnosis of pancreatic ductal adenocarcinoma (resectable, borderline resectable, locally advanced or metastatic)

You may qualify if:

• Patients older than 18 years
• Patients candidated to receive an active treatment (surgery, chemiotherapy, chemio-radiation)
• Patients able to sign the informed consent.

You may not qualify if:

• Patients with a school education level less than 8 years, since the complexity of submitted questionnaires.

Sponsors & Collaborators

• Michele Reni: lead

Study Sites (1)

IRCCS S Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 8433390 BACKGROUND

• 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.

  PMID: 11497387 BACKGROUND

• 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.

  PMID: 26356037 BACKGROUND

• 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.

  PMID: 26747215 BACKGROUND

• 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.

  PMID: 10533475 BACKGROUND

• 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.

  PMID: 4385690 BACKGROUND

• 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.

  PMID: 8493302 BACKGROUND

• 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.

  PMID: 17827524 BACKGROUND

• 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.

  PMID: 7884435 BACKGROUND

• 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.

  PMID: 10390740 BACKGROUND

Study Officials

• Michele Reni, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Bruna Delli Zotti

CONTACT

+390226436173; dellizotti.giuliabruna@hsr.it

Maria Maddalena Valente

CONTACT

+390226437623; valente.mariamaddalena@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 20, 2020
• Study Start: February 10, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

IT (1)