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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03556813
Other study ID # INCASE0518
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date January 20, 2019

Study information

Verified date April 2019
Source Wefight
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 20, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18 years

- paitents with breast cancer

Exclusion Criteria:

- Patient unable to formulate his opposition

- Patient with cancer other than breast cancer

Study Design


Related Conditions & MeSH terms


Intervention

Other:
survey
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.

Locations

Country Name City State
France Wefight Montpellier

Sponsors (1)

Lead Sponsor Collaborator
Wefight

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of 3 months
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