Breast CancerSav-AQNCT03472794
Adaptation of a Knowledges Exchange Portal Between (KEP) Healers and Patients : Obstacles and Sources to KEP Use for Breast Cancer Women
An observational study of Breast Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- web portal: " Mon réseau cancer du sein " ("My Breast cancer Network")
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2018to 17 Jun 2019
- 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: 30 women with a breast cancer will participate to the study, they will represent a sufficient and realis effective considering the active list of treated patients with a breast cancer at the Bergonié Institute. 5 healers (one nurse, two doctors, a senior health manager, a manipulator in medical imaging)
Who may be able to join
- Age ≥ 18 y.o;
- With a diagnosis of breast cancer,
- treated at the Bergonié Institute;
- Patients who express a non-opposition to participate to SAVAQ research;
- Patients who have an Internet access at home.
- Doctors, Nurse, Senior health manager, Technologist medical imaging from the center participated to the research
Who cannot join
- Patients with a severe psychiatric pathology (medical diagnosis);
- Patients who doesn't speak French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of a Knowledges Exchange Portal (KEP) Between Healers and Patients : Study of Obstacles and Sources to the Use of a KEP in the Case of Women Affected by a Breast Cancer in Nouvelle Aquitaine(Sav-AQ)
The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context
Read the detailed description
One of the French Cancer Plan 2014-2019 objectives is to improve the town-hospital coordination and information's exchange between professionals. This research project aims to reach this important objective of exchange development and the amelioration of the coordination concerning breast cancer women. Breast cancer requires the integration of aggressive treatments implying physical, psychological and social consequences. That's why an optimized care pathway needs a coordinated and multidisciplinary organization, and more particularly a personalized approach taking into account the whole patients' needs in physical, psychological and social perspectives. To reach this goal, it is important to support those patients, to answer their needs for a better disease management in their own health pathways. The research issues lie in this outcome.
The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway.
The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context
- Conditions
- Breast Cancer
- Being tested
- web portal: " Mon réseau cancer du sein " ("My Breast cancer Network")
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web portal: " Mon réseau cancer du sein " ("My Breast cancer Network")Other
web portal: " Mon réseau cancer du sein "
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability of the web portal
Number of connections to the portal each month:
- Types of documents consulted
- Types of downloaded documents
- Types of documents sought
- Connection duration
- Number of connections
- Number of comments / questions posted
- Number of comments / questions viewed
- Number of comments / questions sought
Measured: Month 6
Secondary outcomes (18)
Number of the portal connections realized each month
Number of the portal connections realized each month
Measured: Month 6
Number of webpages used
Number of webpages used
Measured: Month 6
Number of status posted
Number of status posted
Measured: Month 6
Number of comments/questions posted
Number of comments/questions posted
Measured: Month 6
Number of "like" emoticon posted
Number of "like" emoticon posted
Measured: Month 6
Number of "comfort" emoticon posted
Number of "comfort" emoticon posted
Measured: Month 6
Number of "favorites" emoticon posted
Number of "favorites" emoticon posted
Measured: Month 6
Number of "mood" posted
Number of "mood" posted
Measured: Month 6
Number of private posts posted
Number of private posts posted
Measured: Month 6
Number of webpages consulted
Number of webpages consulted
Measured: Month 6
Number of leaflets consulted
Number of leaflets consulted
Measured: Month 6
Headings of leaflets consulted
Headings of leaflets consulted
Measured: Month 6
Number of cards consulted
Number of cards consulted
Measured: Month 6
Headings of cards consulted
Headings of cards consulted
Measured: Month 6
Number of videos consulted
Number of videos consulted
Measured: Month 6
Headings of videos consulted
Headings of videos consulted
Measured: Month 6
Number of address consulted in the address list
Number of address consulted in the address list
Measured: Month 6
Number of upcoming events consulted
Number of upcoming events consulted
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start16 Mar 2018
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- SRIOP 2016, SIRIC BRIO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472794
- Sponsor's protocol ID
- CHUBX 2016/19
- Acronym
- Sav-AQ
- Status last verified
- Sep 2019
- First submitted
- 31 Jan 2018
- Last updated
- 4 Sep 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 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Knowledges Exchange Portal (KEP) Between Healers and Patients : Study of Obstacles and Sources to the Use of a KEP in the Case of Women Affected by a Breast Cancer in Nouvelle Aquitaine(Sav-AQ)
- ClinicalTrials.gov ID
- NCT03472794
- Acronym / sponsor ID
- Sav-AQ / CHUBX 2016/19
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- SRIOP 2016, SIRIC BRIO
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 21 Mar 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 project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context
Detailed description
One of the French Cancer Plan 2014-2019 objectives is to improve the town-hospital coordination and information's exchange between professionals. This research project aims to reach this important objective of exchange development and the amelioration of the coordination concerning breast cancer women. Breast cancer requires the integration of aggressive treatments implying physical, psychological and social consequences. That's why an optimized care pathway needs a coordinated and multidisciplinary organization, and more particularly a personalized approach taking into account the whole patients' needs in physical, psychological and social perspectives. To reach this goal, it is important to support those patients, to answer their needs for a better disease management in their own health pathways. The research issues lie in this outcome.
The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway.
The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 women with a breast cancer will participate to the study, they will represent a sufficient and realis effective considering the active list of treated patients with a breast cancer at the Bergonié Institute. 5 healers (one nurse, two doctors, a senior health manager, a manipulator in medical imaging)
Key inclusion criteria (6 listed)
- Age ≥ 18 y.o;
- With a diagnosis of breast cancer,
- treated at the Bergonié Institute;
- Patients who express a non-opposition to participate to SAVAQ research;
- Patients who have an Internet access at home.
Key exclusion criteria (2 listed)
- Patients with a severe psychiatric pathology (medical diagnosis);
- Patients who doesn't speak French
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 |
|---|---|---|
| web portal: " Mon réseau cancer du sein " ("My Breast cancer Network")web portal: " Mon réseau cancer du sein " | Other | – |
Primary outcome
Feasability of the web portal
Time frame: Month 6
Number of connections to the portal each month: * Types of documents consulted * Types of downloaded documents * Types of documents sought * Connection duration * Number of connections * Number of comments / questions posted * Number of comments / questions viewed * Number of comments / questions sought
18 secondary outcomes
Number of the portal connections realized each month
Time frame: Month 6
Number of webpages used
Time frame: Month 6
Number of status posted
Time frame: Month 6
Number of comments/questions posted
Time frame: Month 6
Number of "like" emoticon posted
Time frame: Month 6
Number of "comfort" emoticon posted
Time frame: Month 6
Number of "favorites" emoticon posted
Time frame: Month 6
Number of "mood" posted
Time frame: Month 6
Number of private posts posted
Time frame: Month 6
Number of webpages consulted
Time frame: Month 6
Number of leaflets consulted
Time frame: Month 6
Headings of leaflets consulted
Time frame: Month 6
Number of cards consulted
Time frame: Month 6
Headings of cards consulted
Time frame: Month 6
Number of videos consulted
Time frame: Month 6
Headings of videos consulted
Time frame: Month 6
Number of address consulted in the address list
Time frame: Month 6
Number of upcoming events consulted
Time frame: Month 6
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 4 Sep 2019.
- 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.
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?
An observational study of Breast Cancer, run by University Hospital, Bordeaux 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 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: finished, as of the sponsor's last update on 4 Sep 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?
Feasability of the web portal (time frame: Month 6). 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 4 Sep 2019.