Representation of the Body for Patients With Cancer (CORCAN)
Primary Purpose
Peritoneal Carcinomatosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interviews
Sponsored by
About this trial
This is an interventional basic science trial for Peritoneal Carcinomatosis
Eligibility Criteria
Inclusion Criteria:
- Patients eligible to treatment of cancer by cytoreductive surgery and HIPEC
- Primary (pseudomyxoma, mesothelioma) and secondary (colorectal, gastric, ovarian) peritoneal cancer
- Free consent
- Male or Female
- Age > 18 years
- Affiliate to social security
Exclusion Criteria:
- Age < 18 years, no french speaking
- Cerebrals metastasis
- Psychiatrics diseases
Sites / Locations
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Treated by HIPEC
Standard chemiotherapy
Arm Description
Patients treated by HIPEC for peritoneal cancer
Patients treated by standard chemiotherapy for peritoneal cancer
Outcomes
Primary Outcome Measures
Body representations
Comprehensive knowledge concerning the way the patients are living cancer event, treatment, changes in their body representations and conceptions of their lives.
This qualitative study do not include outcome measures. Its purpose is restricted to the meanings
Secondary Outcome Measures
Full Information
NCT ID
NCT01560533
First Posted
December 12, 2011
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01560533
Brief Title
Representation of the Body for Patients With Cancer
Acronym
CORCAN
Official Title
Representation of the Body and Treatment of Peritoneal Cancer by Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - A Collaborative Approach Between Professionals of Health / Patients / Researchers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project aims to understand better how patients live the event of cancer and live its consequences on their bodily representations. In the study, the dynamic of the body image is not restricted to appearance but include sensations and visions of the inner body, what explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and HIPEC.
The three objectives of the study are:
identifying the impact of the representations of the treated body on the psychological strategies to cope with the disease, the bodily changes and the prospects of life;
making explicit the positive or negative impacts of these representations on the relationship between patients and health professionals (easing factors, misunderstandings, negotiations, etc.);
associating the health professionals with the study in its course and evaluation in order to elaborate a methodological collaborative approach between patients, health professionals and researchers in social sciences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated by HIPEC
Arm Type
Other
Arm Description
Patients treated by HIPEC for peritoneal cancer
Arm Title
Standard chemiotherapy
Arm Type
Other
Arm Description
Patients treated by standard chemiotherapy for peritoneal cancer
Intervention Type
Behavioral
Intervention Name(s)
Interviews
Intervention Description
Interviews will be done with patients
Primary Outcome Measure Information:
Title
Body representations
Description
Comprehensive knowledge concerning the way the patients are living cancer event, treatment, changes in their body representations and conceptions of their lives.
This qualitative study do not include outcome measures. Its purpose is restricted to the meanings
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients eligible to treatment of cancer by cytoreductive surgery and HIPEC
Primary (pseudomyxoma, mesothelioma) and secondary (colorectal, gastric, ovarian) peritoneal cancer
Free consent
Male or Female
Age > 18 years
Affiliate to social security
Exclusion Criteria:
Age < 18 years, no french speaking
Cerebrals metastasis
Psychiatrics diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GLEHEN, Pr
Organizational Affiliation
Hospices Civiles de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26681640
Citation
Durif-Bruckert C, Guilloux R, Guioux A, Lasserre E, Goffette J, Regnier V. [Qualitative and collaborative research with cancer patients. Experience narratives of treatments for peritoneal carcinomatosis]. Bull Cancer. 2016 Feb;103(2):148-53. doi: 10.1016/j.bulcan.2015.10.015. Epub 2015 Dec 8. French.
Results Reference
result
Learn more about this trial
Representation of the Body for Patients With Cancer
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