Cancer of LiverMETISNCT03323996
Impact of a Training in Therapeutic Education on the Relation Between Care Givers and Their Patients
An observational study of Cancer of Liver and Diabetes, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients. Subjects are recruited among health professionals attending a training in therapeutic education. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer of Liver, Diabetes
- What is being tested?
- Semi-Structured interviews
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2017to Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health professionnals attending a training in therapeuthic education and their patients.
Who may be able to join
- Informed consent to participate to 3 interviews
Who cannot join
- Not fluent French speaker
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Morgane BONDIER, Dr, mbondier@chu-besancon.fr
About this study
This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients.
Subjects are recruited among health professionals attending a training in therapeutic education. Then they are asked to identify up to 5 of their patients to be contacted by the researcher for an interview.
Individual semi-structured interviews are conducted with 20 duo "caregivers / patients" before the training, 1 month and 6 months after the training.
- Conditions
- Cancer of Liver, Diabetes
- Being tested
- Semi-Structured interviews
- Medical subject headings
- Liver Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-Structured interviewsOther
individual semi-structured interviews
| Study group | Role | What they receive |
|---|---|---|
| Health Professionals | Health Professionals attending a training in therapeutic education Receives: Other: Semi-Structured interviews | |
| Patients | Patients of the health Professionals recruited for the study Receives: Other: Semi-Structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-Structured interviews
Qualitative analysis - theorical saturation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start26 Jul 2017
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LiverStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323996
- Sponsor's protocol ID
- P/2016/307
- Acronym
- METIS
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 27 Oct 2017
- 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 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Training in Therapeutic Education on the Relation Between Care Givers and Their Patients
- ClinicalTrials.gov ID
- NCT03323996
- Acronym / sponsor ID
- METIS / P/2016/307
- Conditions
- Cancer of Liver, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Oct 2017 (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.
This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients.
Subjects are recruited among health professionals attending a training in therapeutic education. Then they are asked to identify up to 5 of their patients to be contacted by the researcher for an interview.
Individual semi-structured interviews are conducted with 20 duo "caregivers / patients" before the training, 1 month and 6 months after the training.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Professionals | – | Other: Semi-Structured interviewsHealth Professionals attending a training in therapeutic education |
| Patients | – | Other: Semi-Structured interviewsPatients of the health Professionals recruited for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health professionnals attending a training in therapeuthic education and their patients.
Key inclusion criteria (1 listed)
- Informed consent to participate to 3 interviews
Key exclusion criteria (2 listed)
- Not fluent French speaker
- Patient under guardianship
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 |
|---|---|---|
| Semi-Structured interviewsindividual semi-structured interviews | Other | Health Professionals, Patients |
Primary outcome
Semi-Structured interviews
Time frame: 9 months
Qualitative analysis - theorical saturation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- 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.
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 Cancer of Liver and Diabetes, run by Centre Hospitalier Universitaire de Besancon 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile ZIMMERMANN, Dr (+33 3 81 66 91 61, utep.secretariat@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-Structured interviews (time frame: 9 months). 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 27 Oct 2017.