Breast CancerNCT03556813
Artificial Intelligence vs Physicians for Breast Cancer Patients' Information
An observational study of Breast Cancer, run by Wefight at 1 site in France.
Trial summary
Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- survey
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 20 Jan 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast cancer or in remission
Who may be able to join
- over 18 years
- paitents with breast cancer
Who cannot join
- Patient unable to formulate his opposition
- Patient with cancer other than breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence vs Physicians for Breast Cancer Patients' Information : a Blind, Randomized, Controlled Study
Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health.
In clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. There is no longer any delay between the moment the patient notices a side effect, for example, and the moment when the patient announces it during a consultation. The responses given by the chatbot do not constitute medical advice and only provide information on the treatments envisaged or in progress in the context of the management of breast cancer.
The main objective of the study is to show that the chatbot Vik's answers to the common questions asked by breast cancer patients about their therapeutic management are at least as satisfactory as answers given by a committee of multidisciplinary doctors
Read the detailed description
A total of 20 most frequently asked questions will be defined on a cohort of 150 breast cancer patients. These questions will be asked on the one hand to the chatbot Vik and on the other hand to a multidisciplinary medical committee (surgeon oncologist, medical oncologist and oncologist radiotherapist). The scientific quality of the responses of the two groups will be validated by a second multidisciplinary group of physicians, independent of the first.
A cohort of 150 patients will then be randomized blind and in 1 to 1 to receive the responses of the chatbot Vik and the answers of the doctors' committee. Each patient will then have to answer the EORTC QLQ-INFO255-7 questionnaire, evaluating the quality of the medical information.
- Conditions
- Breast Cancer
- Being tested
- survey
- Keywords
- Patient information, Natural Language Processing, Conversational agent, Chatbot
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
non-inferiority study, randomized, blind, excluding health product, with no risk or constraint, in which all the acts are performed in the usual way and do not modify the patient's management.
| Study group | Role | What they receive |
|---|---|---|
| Group Vik | women over the age of 18 with breast cancer or remission Receives: Other: survey | |
| Group physicians | women over the age of 18 with breast cancer or remission Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Patient information
The quality of the participating patient's information about their disease and their treatment will be assessed using the standardized EORTC QLQ-INFO25 survey.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2018
- Study completion20 Jan 2019
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 Breast 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wefight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556813
- Sponsor's protocol ID
- INCASE0518
- Status last verified
- Apr 2019
- First submitted
- 31 May 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bibault JE, Chaix B, Guillemasse A, Cousin S, Escande A, Perrin M, Pienkowski A, Delamon G, Nectoux P, Brouard B. A Chatbot Versus Physicians to Provide Information for Patients With Breast Cancer: Blind, Randomized Controlled Noninferiority Trial. J Med Internet Res. 2019 Nov 27;21(11):e15787. doi: 10.2196/15787.
PubMed 31774408
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence vs Physicians for Breast Cancer Patients' Information : a Blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03556813
- Acronym / sponsor ID
- INCASE0518
- Conditions
- Breast Cancer
- Keywords
- Patient information, Natural Language Processing, Conversational agent, Chatbot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- WefightIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 14 Jun 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.
Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health.
In clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. There is no longer any delay between the moment the patient notices a side effect, for example, and the moment when the patient announces it during a consultation. The responses given by the chatbot do not constitute medical advice and only provide information on the treatments envisaged or in progress in the context of the management of breast cancer.
The main objective of the study is to show that the chatbot Vik's answers to the common questions asked by breast cancer patients about their therapeutic management are at least as satisfactory as answers given by a committee of multidisciplinary doctors
Detailed description
A total of 20 most frequently asked questions will be defined on a cohort of 150 breast cancer patients. These questions will be asked on the one hand to the chatbot Vik and on the other hand to a multidisciplinary medical committee (surgeon oncologist, medical oncologist and oncologist radiotherapist). The scientific quality of the responses of the two groups will be validated by a second multidisciplinary group of physicians, independent of the first.
A cohort of 150 patients will then be randomized blind and in 1 to 1 to receive the responses of the chatbot Vik and the answers of the doctors' committee. Each patient will then have to answer the EORTC QLQ-INFO255-7 questionnaire, evaluating the quality of the medical information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Vik | – | Other: surveywomen over the age of 18 with breast cancer or remission |
| Group physicians | – | Other: surveywomen over the age of 18 with breast cancer or remission |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer or in remission
Key inclusion criteria (2 listed)
- over 18 years
- paitents with breast cancer
Key exclusion criteria (2 listed)
- Patient unable to formulate his opposition
- Patient with cancer other than breast cancer
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 |
|---|---|---|
| surveynon-inferiority study, randomized, blind, excluding health product, with no risk or constraint, in which all the acts are performed in the usual way and do not modify the patient's management. | Other | Group Vik, Group physicians |
Primary outcome
Quality of Patient information
Time frame: Through study completion, an average of 3 months
The quality of the participating patient's information about their disease and their treatment will be assessed using the standardized EORTC QLQ-INFO25 survey.
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 25 Apr 2019.
- Derived from this study: PubMed 31774408Bibault JE, Chaix B, Guillemasse A, Cousin S, Escande A, Perrin M, Pienkowski A, Delamon G, Nectoux P, Brouard B. A Chatbot Versus Physicians to Provide Information for Patients With Breast Cancer: Blind, Randomized Controlled Noninferiority Trial. J Med Internet Res. 2019 Nov 27;21(11):e15787. doi: 10.2196/15787.
- 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 Wefight 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 2 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 25 Apr 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?
Quality of Patient information (time frame: Through study completion, an average of 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 NCT03556813, 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 25 Apr 2019.