Peritoneal CarcinomatosisCORCANNCT01560533
Representation of the Body for Patients With Cancer
A study testing Interviews in people with Peritoneal Carcinomatosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years, no french speaking
- Cerebrals metastasis
- Psychiatrics diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- Interviews
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsBehavioural
Interviews will be done with patients
| Study group | Role | What they receive |
|---|---|---|
| Treated by HIPEC | Other | Patients treated by HIPEC for peritoneal cancer Receives: Behavioral: Interviews |
| Standard chemiotherapy | Other | Patients treated by standard chemiotherapy for peritoneal cancer Receives: Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GLEHEN, Pr, Principal investigator, Hospices Civiles de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560533
- Sponsor's protocol ID
- 2010.640
- Acronym
- CORCAN
- Status last verified
- Jan 2014
- First submitted
- 12 Dec 2011
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26681640
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01560533
- Acronym / sponsor ID
- CORCAN / 2010.640
- Conditions
- Peritoneal Carcinomatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated by HIPEC | Other | Behavioral: InterviewsPatients treated by HIPEC for peritoneal cancer |
| Standard chemiotherapy | Other | Behavioral: InterviewsPatients treated by standard chemiotherapy for peritoneal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years, no french speaking
- Cerebrals metastasis
- Psychiatrics diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsInterviews will be done with patients | Behavioural | Standard chemiotherapy, Treated by HIPEC |
Primary outcome
Body representations
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 26681640Durif-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GLEHEN, Pr principal investigator
Hospices Civiles de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interviews in people with Peritoneal Carcinomatosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body representations (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01560533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.