Clinical trial NCT03556813: Artificial Intelligence vs Physicians for Breast Cancer Patients' Information
Official title: Artificial Intelligence vs Physicians for Breast Cancer Patients' Information : a Blind, Randomized, Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Patient information
Natural Language Processing
Conversational agent
Chatbot
Lead sponsor: Wefight
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer or in remission

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* over 18 years
* paitents with breast cancer

Exclusion Criteria:

* Patient unable to formulate his opposition
* Patient with cancer other than breast cancer

Primary outcomes:
measure: Quality of Patient information
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Wefight
Study officials:
References:
citation: 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.