Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme (AppDate-You)
Primary Purpose
Cervical Cancer Screening, Cervical Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer Screening focused on measuring cervical neoplasia, cervical cancer screening, chatbot, artificial intelligence, cluster randomized controlled trial, HPV vaginal self-sampling
Eligibility Criteria
Inclusion criteria: eligible women will be:
- aged 30-65
- did not perform a pap smear in the last 4 years
- are living in deprived clusters in the Occitanie region.
- did not answer to a first "invitation" letter to perform a clinician-collected HPV testing
Exclusion criteria: ineligible women will be those:
- outside the target age group
- had a Pap smear in the past 3 years
- had hysterectomy including cervix
- are pregnant beyond 6 months
- already scheduled a screening appointment or had just attended a HPV screening
- had a cervical abnormality that was under exploration and/or treatment.
- participated to the study pilot
Sites / Locations
- Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test, with access to a decision aid tool tailored to those with low education levels. This tool will be available via Chatbot platforms.
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care)
Outcomes
Primary Outcome Measures
HPV self-sampling "return" rate
Percent of women recalled who "return" HPVss over 12 months "Return" means: 1) the receipt of the vaginal self-sample at the laboratory; 2) the performance of clinician-collected HPV testing for those who prefer to be screened by a health professional; and 3) Information about a recent screening or a cervical screening exclusion reason.
Proportion of HPVss-positive women "well managed"
Percent of recruited women well managed (Percent of women screened and completing full pathway of HPV screening and treatment over 12 months).
"Well managed" is defined as: completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND
for HPV negative women, woman advised of negative result
for HPV positive women, completed assessment.
Cost and cost-efficacy
Costs will be estimated using an ingredients approach whereby resources used for the respective interventions are identified and valued. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between the intervention groups with the mean difference in effects, and expressed as both euros and US dollars per percentage change in screening participation.
Secondary Outcome Measures
Full Information
NCT ID
NCT05286034
First Posted
March 9, 2022
Last Updated
September 28, 2023
Sponsor
International Agency for Research on Cancer
Collaborators
Centre Régional de Coordination des Dépistages des Cancers, centre-Carcassonne, Université de Bretagne Occidentale, Brest-France
1. Study Identification
Unique Protocol Identification Number
NCT05286034
Brief Title
Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme
Acronym
AppDate-You
Official Title
Artificial Intelligence-assisted Decision-making to Improve Women's Participation to Cervical Cancer Screening in Occitanie Region-France
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Agency for Research on Cancer
Collaborators
Centre Régional de Coordination des Dépistages des Cancers, centre-Carcassonne, Université de Bretagne Occidentale, Brest-France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.
Detailed Description
France has already implemented a cervical screening programme based on HPV test for the whole female population aged 30-65 years. Non-participant women can perform HPV test at their home. However, less than 20% of French women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less to cervical screening. A variety of personal, practitioner, test-related and logistical barriers negatively impact the screening participation of French women. Key barriers to participation could be addressed by overcoming disparities in HPV-related knowledge and perceptions about cervical cancer screening. This study aims to evaluate the impact of sending HPV self-sampling kit at women's home, associated with providing, through multiple mobile channels, a multi-language decision aid designed for women with lower education accessible via artificial intelligence-based ChatBot. This decision aid will help women review high quality evidence on cervical cancer disease and screening modalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Screening, Cervical Cancer
Keywords
cervical neoplasia, cervical cancer screening, chatbot, artificial intelligence, cluster randomized controlled trial, HPV vaginal self-sampling
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A cluster randomized controlled trial with two arms (one experimental arm and one active control arm) will be conducted in the Occitanie region, France to assess the effectiveness of a decision aid accessible via artificial intelligence-based Chatbot platforms to improve the "return" rate of HPV self-samples and the proportion of invited women "well managed" among disadvantaged women. A cluster is defined by aggregated units for statistical information (Ilots Regroupés pour l'Information Statistique, IRIS) and it refers to a target size of 2000 inhabitants per unit. Only IRIS classified as 4 and 5 according to the French version of the European Deprivation Index (EDI) will be included. The study will be conducted as a two-armed nested into the French cervical cancer screening programme in the Occitanie Region. Clusters will be randomly assigned by a computer-generated randomized schedule following simple randomization procedures in a 1:1 ratio.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test, with access to a decision aid tool tailored to those with low education levels. This tool will be available via Chatbot platforms.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care)
Intervention Type
Behavioral
Intervention Name(s)
Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
Intervention Description
Non-compliant women those that have not been screened for more than 4 years and living in the disadvantaged areas will be sent screening reminder letters to perform HPV self-sampling (HPVss) test, with access to decision aid tailored to women with lower education attainment and available via Chatbot platforms.
ChatBot will deliver information in a responsive, conversational way via text and spoken language in multiple languages through multiple mobile channels.
Primary Outcome Measure Information:
Title
HPV self-sampling "return" rate
Description
Percent of women recalled who "return" HPVss over 12 months "Return" means: 1) the receipt of the vaginal self-sample at the laboratory; 2) the performance of clinician-collected HPV testing for those who prefer to be screened by a health professional; and 3) Information about a recent screening or a cervical screening exclusion reason.
Time Frame
1 year after postal mail
Title
Proportion of HPVss-positive women "well managed"
Description
Percent of recruited women well managed (Percent of women screened and completing full pathway of HPV screening and treatment over 12 months).
"Well managed" is defined as: completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND
for HPV negative women, woman advised of negative result
for HPV positive women, completed assessment.
Time Frame
1 year after postal mail
Title
Cost and cost-efficacy
Description
Costs will be estimated using an ingredients approach whereby resources used for the respective interventions are identified and valued. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between the intervention groups with the mean difference in effects, and expressed as both euros and US dollars per percentage change in screening participation.
Time Frame
Month 36 - Month 48
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: eligible women will be:
aged 30-65
did not perform a pap smear in the last 4 years
are living in deprived clusters in the Occitanie region.
did not answer to a first "invitation" letter to perform a clinician-collected HPV testing
Exclusion criteria: ineligible women will be those:
outside the target age group
had a Pap smear in the past 3 years
had hysterectomy including cervix
are pregnant beyond 6 months
already scheduled a screening appointment or had just attended a HPV screening
had a cervical abnormality that was under exploration and/or treatment.
participated to the study pilot
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farida Selmouni, Dr
Phone
+ 33 4 72 73 84 99
Email
selmounif@iarc.fr
Facility Information:
Facility Name
Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
City
Carcassone
ZIP/Postal Code
11000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Guy, MD
Phone
+33 4 99 23 33 58
Email
M.Guy@depistage-occitanie.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35771872
Citation
Selmouni F, Guy M, Muwonge R, Nassiri A, Lucas E, Basu P, Sauvaget C. Effectiveness of Artificial Intelligence-Assisted Decision-making to Improve Vulnerable Women's Participation in Cervical Cancer Screening in France: Protocol for a Cluster Randomized Controlled Trial (AppDate-You). JMIR Res Protoc. 2022 Aug 2;11(8):e39288. doi: 10.2196/39288.
Results Reference
background
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Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme
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