Artificial Intelligence vs Physicians for Breast Cancer Patients' Information
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03556813 |
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Recruitment Status :
Completed
First Posted : June 14, 2018
Last Update Posted : April 25, 2019
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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
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer | Other: survey |
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 Type : | Observational |
| Actual Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Artificial Intelligence vs Physicians for Breast Cancer Patients' Information : a Blind, Randomized, Controlled Study |
| Actual Study Start Date : | November 1, 2018 |
| Actual Primary Completion Date : | December 1, 2018 |
| Actual Study Completion Date : | January 20, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Group Vik
women over the age of 18 with breast cancer or remission
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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. |
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Group physicians
women over the age of 18 with breast cancer or remission
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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. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- over 18 years
- paitents with breast cancer
Exclusion Criteria:
- Patient unable to formulate his opposition
- Patient with cancer other than breast cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556813
| France | |
| Wefight | |
| Montpellier, France, 34000 | |
| Responsible Party: | Wefight |
| ClinicalTrials.gov Identifier: | NCT03556813 |
| Other Study ID Numbers: |
INCASE0518 |
| First Posted: | June 14, 2018 Key Record Dates |
| Last Update Posted: | April 25, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Patient information Natural Language Processing Conversational agent Chatbot |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |