NCT03556813

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

May 31, 2018

Last Update Submit

April 23, 2019

Conditions

Keywords

Patient informationNatural Language ProcessingConversational agentChatbot

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group Vik

women over the age of 18 with breast cancer or remission

Other: survey

Group physicians

women over the age of 18 with breast cancer or remission

Other: survey

Interventions

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.

Group VikGroup physicians

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with breast cancer or in remission

You may qualify if:

  • over 18 years
  • paitents with breast cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wefight

Montpellier, 34000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 14, 2018

Study Start

November 1, 2018

Primary Completion

December 1, 2018

Study Completion

January 20, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations