Pancreas CancerCOSINCT04422730
Evolution of Body Connection After Surgery
An observational study of Pancreas Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Psychological evaluation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 5 Mar 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult people males and females
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case
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
- Being tested
- Psychological evaluation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological evaluationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| pancreatectomy in cancer patients | Not described Receives: Behavioral: Psychological evaluation | |
| pancreatectomy in non-cancer patients | Not described Receives: Behavioral: Psychological evaluation | |
| mastectomy | Not described Receives: Behavioral: Psychological evaluation | |
| Acute leukaemia | Not described Receives: Behavioral: Psychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparaison of Scale of Body Connection score between 4 groups
score from 0 to 5
Measured: 12 months
comparaison of psychological interview between 4 groups
measured by an psychologist interpretation
Measured: 12 months
comparaison of Hospital Anxiety and Dépression score between 4 groups
score from 0 to 21
Measured: 12 months
comparaison of Test IES-R score between 4 groups
score from 0 to100
Measured: 12 months
comparaison of quality of life score between 4 groups
score from 0 to 60
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start30 Jun 2020
- Primary completion5 Mar 2023
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thérèse AURRAN, Dr, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422730
- Sponsor's protocol ID
- COSI-PC-IPC 2019-022
- Acronym
- COSI
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2019
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case
- ClinicalTrials.gov ID
- NCT04422730
- Acronym / sponsor ID
- COSI / COSI-PC-IPC 2019-022
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 9 Jun 2020 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pancreatectomy in cancer patients | – | Behavioral: Psychological evaluation |
| pancreatectomy in non-cancer patients | – | Behavioral: Psychological evaluation |
| mastectomy | – | Behavioral: Psychological evaluation |
| Acute leukaemia | – | Behavioral: Psychological evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult people males and females
Key inclusion criteria (6 listed)
- 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:
- No patient's opposition to the information provided
- Affiliated to the social security plan or beneficiary
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Psychological evaluationPatients 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 | Behavioural | Acute leukaemia, mastectomy, pancreatectomy in cancer patients, pancreatectomy in non-cancer patients |
Primary outcome
comparaison of Scale of Body Connection score between 4 groups
Time frame: 12 months
score from 0 to 5
comparaison of psychological interview between 4 groups
Time frame: 12 months
measured by an psychologist interpretation
comparaison of Hospital Anxiety and Dépression score between 4 groups
Time frame: 12 months
score from 0 to 21
comparaison of Test IES-R score between 4 groups
Time frame: 12 months
score from 0 to100
comparaison of quality of life score between 4 groups
Time frame: 12 months
score from 0 to 60
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 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Thérèse AURRAN, Dr principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, 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 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 1 Oct 2026. 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?
comparaison of Scale of Body Connection score between 4 groups (time frame: 12 months). The study lists 5 primary outcomes in all. 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 1 Oct 2026.