Psychological Effect of the pancréatectomy: a Feeling of Strangeness

NCT03686592 | Completed

• 1 other identifier: REPPSE-IPC 2017-007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The cancer of the pancreas represents 1,8 % of cancers in France, with 9040 new cases in 2011 (France). This cancer is known to be of dark forecast. Indeed, of late clinical expression, is diagnosed most of the time at a late stage . For that reason, the cancer of the pancreas is considered as the one who presents the least good prognosis for survival. He affects more frequently the men than the women (rate of incidence of 7,7 against 4,7 cases for 100 000). Between 1980 and 2005, the incidence increased by 3,8 % at the women, by 2,0 % at the men (INCA Source, on 2012). The number of cases of cancer of the pancreas in the world is estimated at 278 684, with 266 669 deaths a year (Cancer Incidence and Mortality Worldwide - Globocan, on 2008). In these cases of very grave cancers, the surgery represents the unique treatment to curative aim, although always not warning of a risk of relapse, and susceptible of entrainer to complications. Thus the pancréatectomy establishes a modality of specific treatment. Remaining the ultimate chance of cure, it is only rarely possible. Indeed, only 10 in 20 % of the cancers of the pancreas exocrines can be handled by surgery when the latter establish 95 % of the cases of pancreatic cancer. To date, the psychosomatic approach goes away from the search for the causes to be interested more and more in the psychological consequences of the somatic disorders, what we wish to study in the present search. Once the surgical indication was put, one of the key elements in the psychological plan is the uncertainty as for the outcome of the ablation, as well as the consequences psychopathologiques which ensue from it. The mutilation of an organ, whatever it is, can have an impact on the identity of the person constituting at the same time a physical and narcissistic wound, while having psychological effect at the sick person such as of the anxiety, a depression, or another a state of post-traumatic stress. More exactly, a study was able to show a positive relation between cancer of the pancreas and depression in a retrospective study. A review of literature concerning the specific relations between depression and cancer of the pancreas was also realized. Besides, 50 % of the patients have a significant level of anxiety and 15 % of depression. A study was nevertheless able to bring to light that the depression does not affect the survival of the patient. Finally, a study was also able to find a decrease marked with the quality of life of the patients during the next first 6 months the operation. Various studies so studied the quality of life of the patients reached of a cancer of the pancreas in particular in comment surgery. It is also advisable to specify that besides the depression and the quality of life, the strategies of adaptation of the patients having undergone a pancréatectomy were also the object of studies. However, none documented, to date, the specific psychological consequences described clinically by certain patients, in particular the feeling of confusion and strangeness felt, and it in association with the possible presence of a state of post-traumatic stress in several weeks of the operation.

Conditions

Pancreatectomy

Keywords

Pancreatic cancer; body awareness; post-traumatic stress

Outcome Measures

Primary Outcomes (1)

• Measurement of body awareness

  body awareness will be measured thanks to a scale of Body Connection questionnaire

  1 day

Secondary Outcomes (1)

• Evaluation of post-traumatic stress

  1 day

Study Arms (2)

pancreatectomized patients

EXPERIMENTAL

Patients with pancreatic cancer who underwent a pancreatectomy at Institut Paoli Calmettes

Other: Measurement of body awareness

Volunteers

ACTIVE COMPARATOR

Other: Measurement of body awareness

Interventions

Measurement of body awareness OTHER

Questionnaires+ interviews

Volunteers; pancreatectomized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of at least 18 years, presenting a good understanding and a practice of the French language,
• Having undergone a pancreatectomy (pancreatic cancer),
• Signed Consent of participation,
• Affiliating to a national social security or beneficiary of such regimen

You may not qualify if:

• Other medical or psychiatric affection,
• Level of incompatible cognitive efficiency with the answer to auto-questionnaires,
• Patient in emergency situation, major person being the object of a legal protective measure (major under guardianship, guardianship or protection(saving) of justice), or outside state to express its consent.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

GENRE

Marseille, 13273, France

Location

Related Links

• Institut Paoli-Calmettes

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: April 20, 2018
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)