Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women

NCT04689178 | Unknown

• 1 other identifier: RC20_0364
• Study Type: interventional
• Target: 195,000
• Locations: 1 country
• Sites: 1

Brief Summary

Context: In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women. Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality. To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test. Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations. The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).

Conditions

Cervical Cancer

Keywords

Cervical cancer screening; General Practitioner; Organized screening

Outcome Measures

Primary Outcomes (1)

• Proportion of women aged 40-65 who performed a screening test (HPV test or PAP smear) over the last 3 years, 6 months after the intervention

  6 months

Secondary Outcomes (9)

• Description of the types of screening tests carried out in first intention

  6 months

• Description of the types of screening tests carried out in first intention

  6 months

• Description of the results of screening tests carried out in first intention

  6 months

• Description of the types of tests performed for follow-up of lesions detected

  6 months

• Description of the types of tests performed to follow lesions detected by screening

  12 months

Study Arms (3)

Invitation letter + GP reminder (Arm 1)

EXPERIMENTAL

Other: Invitation letter + GP reminder

Invitation letter (Arm 2)

ACTIVE COMPARATOR

Other: Invitation letter

Usual care (Arm 3)

NO INTERVENTION

Interventions

Invitation letter + GP reminder OTHER

40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test, AND GPs will receive the list of their 40-65 year-old patients who did not perform a PAP test over the last 3 years

Invitation letter + GP reminder (Arm 1)

Invitation letter OTHER

40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients.

Invitation letter (Arm 2)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All GPs practicing in the Loire-Atlantique region (Western France) will be included.
• women aged 40 to 65 years,
• being on the patient list of the GPs participating in the study,
• living in the Loire-Atlantique region (Western France),
• being affiliated to the National Health Insurance.

You may not qualify if:

• \- GPs who could refuse to participate by contacting the research team.
• Refusal to participate to the study
• Female patients who underwent total hysterectomy and those who received a pathological result of a previous pap smear (asc-us or CIN) are not eligible to participate in the CC screening and therefore excluded from the study.
• Women not registered with a GP located in Loire-Atlantique will not be included.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

Related Publications (1)

• Teigne D, Banaszuk AS, Grimault C, Abes L, Gaultier A, Rat C. Cervical cancer screening uptake: A randomized controlled trial assessing the effect of sending invitation letters to non-adherent women combined with sending their general practitioners a list of their non-adherent patients (study protocol). Front Public Health. 2022 Nov 10;10:1035288. doi: 10.3389/fpubh.2022.1035288. eCollection 2022.

  PMID: 36438208 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cedric RAT, Professor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Anne-Sophie BANASZUK, Doctor

  Centre de coordination des dépistages des cancers (CRCDC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 30, 2020
• Study Start: January 8, 2021
• Primary Completion: July 2, 2021
• Study Completion: December 2, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)