NCT01560533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 28, 2019

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

December 12, 2011

Last Update Submit

May 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (2)

Treated by HIPEC

OTHER

Patients treated by HIPEC for peritoneal cancer

Behavioral: Interviews

Standard chemiotherapy

OTHER

Patients treated by standard chemiotherapy for peritoneal cancer

Behavioral: Interviews

Interventions

InterviewsBEHAVIORAL

Interviews will be done with patients

Standard chemiotherapyTreated by HIPEC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years, no french speaking
  • Cerebrals metastasis
  • Psychiatrics diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Olivier GLEHEN, Pr

    Hospices Civiles de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

March 22, 2012

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 28, 2019

Record last verified: 2014-01

Locations