Cervical Cancer
Conditions
Keywords
Cervical cancer, screening program, pilot project, randomised control trial, France
Brief summary
A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit (Outreach arm), choice between self-sampling or healthcare provider sampling (Choice arm), and standard care (control arm) in two French departments.
Detailed description
In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The Outreach arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The Choice arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the Outreach arm and reminders at 6 months post-positive result in the Choice arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.
Interventions
OTHERWomen receive invitation letter with HPV self-sampling kit
Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.
OTHERWomen receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider
Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.
Sponsors
Centre Régional de Coordination des Dépistages des Cancers de Grand Est
Central Hospital, Nancy, France
CHU de Reims
International Agency for Research on Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This is a three-arm study
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 30 to 65 years old * Living in the study area (Departments of Marne and Aube, France) * At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)
Exclusion criteria
* Outside the target age (less than 30 years old, or 66 years old and more) * Already participating in the current screening round * Total hysterectomy * History of cervical cancer * Current follow-up for abnormal cervical screening result or cervical lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation rate in cervical cancer screening | 18 months after invitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV positivity rate | 12 months after invitation | — |
| Invalid result rate | 18 months | — |
| Triage cytology completion rate after positive HPV test | 6 months after positive result | — |
| Women's acceptability of HPV self-sampling | 24 months | Qualitative assessment through semi-structured interviews with 40 women to assess women's acceptability of HPV self-sampling |
| Cost-effectiveness of screening strategies | 24 months | Costs will be estimated using an ingredients approach whereby resources used for the respective interventions (' Outreach ' and ' Choice' strategies) are identified and valued. The analysis will include all costs incurred by the screening program, including invitation materials, self-sampling kits, laboratory testing, result communication, and follow-up coordination. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between each intervention arm and the control arm, divided by the mean difference in screening participation rates. Results will be expressed in euros per percentage change in screening participation. |
| Time from HPV-positive result to completion of cytological triage | 18 months | — |
Countries
France
Contacts
Primary ContactFarida Selmouni, PhD
Backup ContactCatherine Sauvaget, MD, PhD
Outcome results
None listed