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Completed

NCT Number: NCT04422730

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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli-Calmettes

Marseille, 13009, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

psychological evaluation

Behavioral

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 outcomes

  1. comparaison of Scale of Body Connection score between 4 groups

    Time frame: 12 months

    score from 0 to 5

  2. comparaison of psychological interview between 4 groups

    Time frame: 12 months

    measured by an psychologist interpretation

  3. comparaison of Hospital Anxiety and Dépression score between 4 groups

    Time frame: 12 months

    score from 0 to 21

  4. comparaison of Test IES-R score between 4 groups

    Time frame: 12 months

    score from 0 to100

  5. comparaison of quality of life score between 4 groups

    Time frame: 12 months

    score from 0 to 60

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 9, 2020
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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