Evolution of Body Connection After Surgery

June 29, 2023 updated by: Institut Paoli-Calmettes

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Marseille, France, 13009
        • Institut Paoli-Calmettes

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult people males and females

Description

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.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparaison of Scale of Body Connection score between 4 groups
Time Frame: 12 months
score from 0 to 5
12 months
comparaison of psychological interview between 4 groups
Time Frame: 12 months
measured by an psychologist interpretation
12 months
comparaison of Hospital Anxiety and Dépression score between 4 groups
Time Frame: 12 months
score from 0 to 21
12 months
comparaison of Test IES-R score between 4 groups
Time Frame: 12 months
score from 0 to100
12 months
comparaison of quality of life score between 4 groups
Time Frame: 12 months
score from 0 to 60
12 months

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Thérèse AURRAN, Dr, Institut Paoli-Calmettes

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 Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COSI-PC-IPC 2019-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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