PancreatectomyREPPSENCT03686592
Psychological Effect of the pancréatectomy: a Feeling of Strangeness
A study testing Measurement of body awareness in people with Pancreatectomy, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The cancer of the pancreas represents 1,8 % of cancers in France, with 9040 new cases in 2011 (France). This cancer is known to be of dark forecast. Indeed, of late clinical expression, is diagnosed most of the time at a late stage . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatectomy
- What is being tested?
- Measurement of body awareness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2018to 11 Jan 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of at least 18 years, presenting a good understanding and a practice of the French language,
- Having undergone a pancreatectomy (pancreatic cancer),
- Signed Consent of participation,
- Affiliating to a national social security or beneficiary of such regimen
Who cannot join
- Other medical or psychiatric affection,
- Level of incompatible cognitive efficiency with the answer to auto-questionnaires,
- Patient in emergency situation, major person being the object of a legal protective measure (major under guardianship, guardianship or protection(saving) of justice), or outside state to express its consent.
Trial locations and contacts
1 site in 1 country.
About this study
The cancer of the pancreas represents 1,8 % of cancers in France, with 9040 new cases in 2011 (France). This cancer is known to be of dark forecast. Indeed, of late clinical expression, is diagnosed most of the time at a late stage . For that reason, the cancer of the pancreas is considered as the one who presents the least good prognosis for survival. He affects more frequently the men than the women (rate of incidence of 7,7 against 4,7 cases for 100 000). Between 1980 and 2005, the incidence increased by 3,8 % at the women, by 2,0 % at the men (INCA Source, on 2012). The number of cases of cancer of the pancreas in the world is estimated at 278 684, with 266 669 deaths a year (Cancer Incidence and Mortality Worldwide - Globocan, on 2008).
In these cases of very grave cancers, the surgery represents the unique treatment to curative aim, although always not warning of a risk of relapse, and susceptible of entrainer to complications. Thus the pancréatectomy establishes a modality of specific treatment. Remaining the ultimate chance of cure, it is only rarely possible. Indeed, only 10 in 20 % of the cancers of the pancreas exocrines can be handled by surgery when the latter establish 95 % of the cases of pancreatic cancer.
Read more
To date, the psychosomatic approach goes away from the search for the causes to be interested more and more in the psychological consequences of the somatic disorders, what we wish to study in the present search.
Once the surgical indication was put, one of the key elements in the psychological plan is the uncertainty as for the outcome of the ablation, as well as the consequences psychopathologiques which ensue from it. The mutilation of an organ, whatever it is, can have an impact on the identity of the person constituting at the same time a physical and narcissistic wound, while having psychological effect at the sick person such as of the anxiety, a depression, or another a state of post-traumatic stress.
More exactly, a study was able to show a positive relation between cancer of the pancreas and depression in a retrospective study. A review of literature concerning the specific relations between depression and cancer of the pancreas was also realized. Besides, 50 % of the patients have a significant level of anxiety and 15 % of depression. A study was nevertheless able to bring to light that the depression does not affect the survival of the patient. Finally, a study was also able to find a decrease marked with the quality of life of the patients during the next first 6 months the operation.
Various studies so studied the quality of life of the patients reached of a cancer of the pancreas in particular in comment surgery. It is also advisable to specify that besides the depression and the quality of life, the strategies of adaptation of the patients having undergone a pancréatectomy were also the object of studies. However, none documented, to date, the specific psychological consequences described clinically by certain patients, in particular the feeling of confusion and strangeness felt, and it in association with the possible presence of a state of post-traumatic stress in several weeks of the operation.
Read the detailed description
The objective of this exploratory research is to identify and to describe the psychological specificities of the pancréatectomy which can in particular include the feeling of strangeness and confusion at the sick person towards its own body.
It will also be a question of estimating the relations of this experience with a possible state of post-traumatic stress. Indeed, the announcement of the cancer as well as the surgery in itself are two elements which can be considered as traumatic.
For it a double methodology will be used, with a design cross-sectionnal: a quantitative shutter(sector) (auto-questionnaires) allowing to study aspects of the psychosocial functioning, and qualitative shutter with a semi-structured interview concerning the subjective experience of the participants. For the interpretation of the meditative data of the conversations, we shall use the phenomenological interpretative analysis ( IPA) which will allow us to investigate in a comprehensive way the subjective experience of the participants by studying the way the people give meaning to the fact that they live.
- Conditions
- Pancreatectomy
- Being tested
- Measurement of body awareness
- Keywords
- Pancreatic cancer, body awareness, post-traumatic stress
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of body awarenessOther
Questionnaires+ interviews
| Study group | Role | What they receive |
|---|---|---|
| pancreatectomized patients | Experimental | Patients with pancreatic cancer who underwent a pancreatectomy at Institut Paoli Calmettes Receives: Other: Measurement of body awareness |
| Volunteers | Active comparator | Not described Receives: Other: Measurement of body awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of body awareness
body awareness will be measured thanks to a scale of Body Connection questionnaire
Measured: 1 day
Secondary outcomes (1)
Evaluation of post-traumatic stress
Post-traumatic stress will be evaluated thanks to a questionnaire+ an interview
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start20 Apr 2018
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686592
- Sponsor's protocol ID
- REPPSE-IPC 2017-007
- Acronym
- REPPSE
- Status last verified
- Jan 2019
- First submitted
- 25 Sep 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Effect of the pancréatectomy: a Feeling of Strangeness
- ClinicalTrials.gov ID
- NCT03686592
- Acronym / sponsor ID
- REPPSE / REPPSE-IPC 2017-007
- Conditions
- Pancreatectomy
- Keywords
- Pancreatic cancer, body awareness, post-traumatic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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 cancer of the pancreas represents 1,8 % of cancers in France, with 9040 new cases in 2011 (France). This cancer is known to be of dark forecast. Indeed, of late clinical expression, is diagnosed most of the time at a late stage . For that reason, the cancer of the pancreas is considered as the one who presents the least good prognosis for survival. He affects more frequently the men than the women (rate of incidence of 7,7 against 4,7 cases for 100 000). Between 1980 and 2005, the incidence increased by 3,8 % at the women, by 2,0 % at the men (INCA Source, on 2012). The number of cases of cancer of the pancreas in the world is estimated at 278 684, with 266 669 deaths a year (Cancer Incidence and Mortality Worldwide - Globocan, on 2008).
In these cases of very grave cancers, the surgery represents the unique treatment to curative aim, although always not warning of a risk of relapse, and susceptible of entrainer to complications. Thus the pancréatectomy establishes a modality of specific treatment. Remaining the ultimate chance of cure, it is only rarely possible. Indeed, only 10 in 20 % of the cancers of the pancreas exocrines can be handled by surgery when the latter establish 95 % of the cases of pancreatic cancer.
To date, the psychosomatic approach goes away from the search for the causes to be interested more and more in the psychological consequences of the somatic disorders, what we wish to study in the present search.
Once the surgical indication was put, one of the key elements in the psychological plan is the uncertainty as for the outcome of the ablation, as well as the consequences psychopathologiques which ensue from it. The mutilation of an organ, whatever it is, can have an impact on the identity of the person constituting at the same time a physical and narcissistic wound, while having psychological effect at the sick person such as of the anxiety, a depression, or another a state of post-traumatic stress.
More exactly, a study was able to show a positive relation between cancer of the pancreas and depression in a retrospective study. A review of literature concerning the specific relations between depression and cancer of the pancreas was also realized. Besides, 50 % of the patients have a significant level of anxiety and 15 % of depression. A study was nevertheless able to bring to light that the depression does not affect the survival of the patient. Finally, a study was also able to find a decrease marked with the quality of life of the patients during the next first 6 months the operation.
Various studies so studied the quality of life of the patients reached of a cancer of the pancreas in particular in comment surgery. It is also advisable to specify that besides the depression and the quality of life, the strategies of adaptation of the patients having undergone a pancréatectomy were also the object of studies. However, none documented, to date, the specific psychological consequences described clinically by certain patients, in particular the feeling of confusion and strangeness felt, and it in association with the possible presence of a state of post-traumatic stress in several weeks of the operation.
Detailed description
The objective of this exploratory research is to identify and to describe the psychological specificities of the pancréatectomy which can in particular include the feeling of strangeness and confusion at the sick person towards its own body.
It will also be a question of estimating the relations of this experience with a possible state of post-traumatic stress. Indeed, the announcement of the cancer as well as the surgery in itself are two elements which can be considered as traumatic.
For it a double methodology will be used, with a design cross-sectionnal: a quantitative shutter(sector) (auto-questionnaires) allowing to study aspects of the psychosocial functioning, and qualitative shutter with a semi-structured interview concerning the subjective experience of the participants. For the interpretation of the meditative data of the conversations, we shall use the phenomenological interpretative analysis ( IPA) which will allow us to investigate in a comprehensive way the subjective experience of the participants by studying the way the people give meaning to the fact that they live.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatectomized patients | Experimental | Other: Measurement of body awarenessPatients with pancreatic cancer who underwent a pancreatectomy at Institut Paoli Calmettes |
| Volunteers | Active comparator | Other: Measurement of body awareness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient of at least 18 years, presenting a good understanding and a practice of the French language,
- Having undergone a pancreatectomy (pancreatic cancer),
- Signed Consent of participation,
- Affiliating to a national social security or beneficiary of such regimen
Key exclusion criteria (3 listed)
- Other medical or psychiatric affection,
- Level of incompatible cognitive efficiency with the answer to auto-questionnaires,
- Patient in emergency situation, major person being the object of a legal protective measure (major under guardianship, guardianship or protection(saving) of justice), or outside state to express its consent.
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 |
|---|---|---|
| Measurement of body awarenessQuestionnaires+ interviews | Other | Volunteers, pancreatectomized patients |
Primary outcome
Measurement of body awareness
Time frame: 1 day
body awareness will be measured thanks to a scale of Body Connection questionnaire
1 secondary outcome
Evaluation of post-traumatic stress
Time frame: 1 day
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 23 Jan 2019.
- Institut Paoli-CalmettesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pancreatectomy
RecruitingObservational study
Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy
Pancreatic Neoplasms, Distal Pancreatectomy (DP)
Recruiting
Feasibility of a 4-Week Intensive Postoperative Multimodal Rehabilitation Program in Complicated Patients After Proximal Pancreatectomy: A Prospective Single-Cohort Study
Pancreatic Diseases
Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Cyst of Pancreas, Pancreatectomy
Active, not recruitingPhase 1
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
Chronic Pancreatitis, Mesenchymal Stem Cells
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of body awareness in people with Pancreatectomy, run by Institut Paoli-Calmettes 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 4 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 23 Jan 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?
Measurement of body awareness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.