Cervical CancerIMPACTGPNCT04689178
Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women
A study testing Invitation letter + GP reminder and Invitation letter in people with Cervical Cancer, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Invitation letter + GP reminder and Invitation letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195,000 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2021to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- GPs who could refuse to participate by contacting the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women Combined With Sending Their General Practitioners a List of Their Nonadherent Patients
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.
Read more
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).
Read the detailed description
Design, Setting and Participants:
The investigators will conduct a 3-arm, cluster-randomized, controlled trial in the Loire-Atlantique region, in France.
The study will include a total of 1,500 GPs and about 100,000 women. The randomization will be based on GP practices to avoid a contamination bias resulting from shared tracking mechanisms and communication between GPs within a given practice. Thus, several GPs working in the same practice will be assigned to the same study arm. Women on the patient list of a given GP will be assigned to the arm of this GP.
Intervention:
After a cluster randomization according to the practice, the GPs and their female patients will be included in one of the following 3 arms:
- "Invitation letter + GP reminder" (Arm 1): 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" (Arm 2): 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.
- "Usual care" (arm 3): 40-65 year-old women who did not perform a PAP test over the last 3 years will NOT receive any invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients.
Expected Results
The investigators expect an increase in the proportion of women who perform a screening test in the intervention arm (arm 1), compared to arms 2 and 3. Previous studies have suggested that the proportion of women adherent to CC screening could be increased by 25% in arm 1 compared to arm 3, whereas the participation could be increased by 15% in arm 2 compared to arm 3.
Considering that the proportion of adherent women in arm 3 should be of about 55%, the absolute increase in participation could reach 11% in arm 1, and 6.6% in arm 2.
A higher adherence to CC screening could improve the detection of pathological lesions by 5% for pathological pap smears and by 10% for positive HPV tests.
- Conditions
- Cervical Cancer
- Being tested
- Invitation letter + GP reminder, Invitation letter
- Keywords
- Cervical cancer screening, General Practitioner, Organized screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation letter + GP reminderOther
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 letterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Invitation letter + GP reminder (Arm 1) | Experimental | Not described Receives: Other: Invitation letter + GP reminder |
| Invitation letter (Arm 2) | Active comparator | Not described Receives: Other: Invitation letter |
| Usual care (Arm 3) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
Description of the types of screening tests carried out in first intention
Proportion of cytological tests performed among all screening tests
Measured: 6 months
Description of the types of screening tests carried out in first intention
Proportion of HPV tests performed among all screening tests
Measured: 6 months
Description of the results of screening tests carried out in first intention
Proportion of abnormal test results (cytology, HPV) among all screening tests performed
Measured: 6 months
Description of the types of tests performed for follow-up of lesions detected
Proportion of "reflex" tests performed (number of cervical smears after a positive HPV result) among abnormal test results
Measured: 6 months
Description of the types of tests performed to follow lesions detected by screening
Proportion of biopsies and conizations performed among abnormal screening test results
Measured: 12 months
Description the results of the tests performed to follow lesions detected by screening
Proportion of high-grade lesions detected (second, a third-grade cervical intraepithelial neoplasia, including in situ carcinomas and cancers) among the abnormal screening tests
Measured: 12 months
Description of the treatments undergone by the women following abnormal screening tests
Percentages of treatments performed (conization, laser, hysterectomy) among the abnormal screening tests
Measured: 12 months
Description of the factors associated with lower participation in screening
Participation rate according to age (over 50), income (women with low incomes qualifying for basic health coverage) and comorbidities.
Measured: 6 months
Description of the healthcare trajectory of women undergoing a screening test
Proportion of women who resort to a GP, a midwife or a gynaecologist to undergo their screening test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start8 Jan 2021
- Primary completion2 Jul 2021
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cedric RAT, Professor, Principal investigator, Nantes University HospitalAnne-Sophie BANASZUK, Doctor, Principal investigator, Centre de coordination des dépistages des cancers (CRCDC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689178
- Sponsor's protocol ID
- RC20_0364
- Acronym
- IMPACTGP
- Status last verified
- Feb 2023
- First submitted
- 27 Nov 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36438208
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women Combined With Sending Their General Practitioners a List of Their Nonadherent Patients
- ClinicalTrials.gov ID
- NCT04689178
- Acronym / sponsor ID
- IMPACTGP / RC20_0364
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer screening, General Practitioner, Organized screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Design, Setting and Participants:
The investigators will conduct a 3-arm, cluster-randomized, controlled trial in the Loire-Atlantique region, in France.
The study will include a total of 1,500 GPs and about 100,000 women. The randomization will be based on GP practices to avoid a contamination bias resulting from shared tracking mechanisms and communication between GPs within a given practice. Thus, several GPs working in the same practice will be assigned to the same study arm. Women on the patient list of a given GP will be assigned to the arm of this GP.
Intervention:
After a cluster randomization according to the practice, the GPs and their female patients will be included in one of the following 3 arms:
- "Invitation letter + GP reminder" (Arm 1): 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" (Arm 2): 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.
- "Usual care" (arm 3): 40-65 year-old women who did not perform a PAP test over the last 3 years will NOT receive any invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients.
Expected Results
The investigators expect an increase in the proportion of women who perform a screening test in the intervention arm (arm 1), compared to arms 2 and 3. Previous studies have suggested that the proportion of women adherent to CC screening could be increased by 25% in arm 1 compared to arm 3, whereas the participation could be increased by 15% in arm 2 compared to arm 3.
Considering that the proportion of adherent women in arm 3 should be of about 55%, the absolute increase in participation could reach 11% in arm 1, and 6.6% in arm 2.
A higher adherence to CC screening could improve the detection of pathological lesions by 5% for pathological pap smears and by 10% for positive HPV tests.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- GPs who could refuse to participate by contacting the research team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation letter + GP reminder40-65 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 | Other | Invitation letter + GP reminder (Arm 1) |
| Invitation letter40-65 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. | Other | Invitation letter (Arm 2) |
Primary outcome
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
Time frame: 6 months
9 secondary outcomes
Description of the types of screening tests carried out in first intention
Time frame: 6 months
Description of the types of screening tests carried out in first intention
Time frame: 6 months
Description of the results of screening tests carried out in first intention
Time frame: 6 months
Description of the types of tests performed for follow-up of lesions detected
Time frame: 6 months
Description of the types of tests performed to follow lesions detected by screening
Time frame: 12 months
Description the results of the tests performed to follow lesions detected by screening
Time frame: 12 months
Description of the treatments undergone by the women following abnormal screening tests
Time frame: 12 months
Description of the factors associated with lower participation in screening
Time frame: 6 months
Description of the healthcare trajectory of women undergoing a screening test
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 36438208Teigne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedric RAT, Professor principal investigator
Nantes University Hospital
Anne-Sophie BANASZUK, Doctor principal investigator
Centre de coordination des dépistages des cancers (CRCDC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation letter + GP reminder and Invitation letter in people with Cervical Cancer, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.