Evolution of Body Connection After Surgery

Pancreas Cancer Clinical Trial

Official title:

Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04422730
• Other study ID #: COSI-PC-IPC 2019-022
• Status: Active, not recruiting
• Start date: June 30, 2020
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is older than 18 years old

• With a good understanding and practice of the French language

• And depending on the group, experimental or control, presenting:

• pancreatic cancer expected to be treated with pancreatectomy or planned to be treated with pancreatectomy excluding cancer or breast cancer scheduled to be treated with mastectomy or acute leukaemia at a recent diagnosis (21 days).

• No patient's opposition to the information provided

• Affiliated to the social security plan or beneficiary

Exclusion Criteria:

• Other medical or psychiatric condition,

• Level of cognitive efficiency incompatible with response to questions about himself,

• A person in an emergency situation, a person under legal protection or unable to express the non opposition to their participation to research.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Psychological evaluation
Patients will be answer to validated test about how they feel. Psychological interview is also possible depending on patients availability. The different answers will be compared between the four groups

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparaison of Scale of Body Connection score between 4 groups	score from 0 to 5	12 months
Primary	comparaison of psychological interview between 4 groups	measured by an psychologist interpretation	12 months
Primary	comparaison of Hospital Anxiety and De´pression score between 4 groups	score from 0 to 21	12 months
Primary	comparaison of Test IES-R score between 4 groups	score from 0 to100	12 months
Primary	comparaison of quality of life score between 4 groups	score from 0 to 60	12 months