Clinical Trial Record

Return to Clinical Trials

Evolution of Body Connection After Surgery


2020-06-30


2023-03-05


2024-03-05


129

Study Overview

Evolution of Body Connection After Surgery

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.

N/A

  • Pancreas Cancer
  • BEHAVIORAL: Psychological evaluation
  • COSI-PC-IPC 2019-022

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-12-02  

N/A  

2025-06-13  

2020-06-05  

N/A  

2025-06-18  

2020-06-09  

N/A  

2024-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: pancreatectomy in cancer patients

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
: pancreatectomy in non-cancer patients

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
: mastectomy

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
: Acute leukaemia

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
Primary Outcome MeasuresMeasure DescriptionTime Frame
comparaison of Scale of Body Connection score between 4 groupsscore from 0 to 512 months
comparaison of psychological interview between 4 groupsmeasured by an psychologist interpretation12 months
comparaison of Hospital Anxiety and Dépression score between 4 groupsscore from 0 to 2112 months
comparaison of Test IES-R score between 4 groupsscore from 0 to10012 months
comparaison of quality of life score between 4 groupsscore from 0 to 6012 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Thérèse AURRAN, Dr, Institut Paoli-Calmettes

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available