Evolution of Body Connection After Surgery

NCT04422730 | Completed

• 1 other identifier: COSI-PC-IPC 2019-022
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (5)

• comparaison of Scale of Body Connection score between 4 groups

  score from 0 to 5

  12 months

• comparaison of psychological interview between 4 groups

  measured by an psychologist interpretation

  12 months

• comparaison of Hospital Anxiety and Dépression score between 4 groups

  score from 0 to 21

  12 months

• comparaison of Test IES-R score between 4 groups

  score from 0 to100

  12 months

• comparaison of quality of life score between 4 groups

  score from 0 to 60

  12 months

Study Arms (4)

pancreatectomy in cancer patients

Behavioral: Psychological evaluation

pancreatectomy in non-cancer patients

Behavioral: Psychological evaluation

mastectomy

Behavioral: Psychological evaluation

Acute leukaemia

Behavioral: Psychological evaluation

Interventions

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

Acute leukaemia; mastectomy; pancreatectomy in cancer patients; pancreatectomy in non-cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult people males and females

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

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 Officials

• Thérèse AURRAN, Dr

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: June 9, 2020
• Study Start: June 30, 2020
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2024
• Last Updated: June 18, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)