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Standard invitation with additional leaflet containing information concerning particular doctor performing the examination, that is: his personal data (name, surname, academic title, workplace, picture) and data concerning experience and achievements of the center where he is employed.

Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination

Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.

Invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.

Invitation letter

Jaroslaw Regula, MD, PhD

Krzysztof Skoczylas, MD

Michal F Kaminski, MD

The purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate to screening colonoscopy.

Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is intended to investigate the effect of screening colonoscopy on colorectal cancer incidence and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden, Netherlands and Poland.

This study is designed to assess two factors potentially influencing patients attendance. These two factors are: identification of particular doctor performing examination and the possibility of choosing doctor's gender.

Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy

Is the Information About a Doctor or Possibility of Choosing Doctor's Gender Associated With Attendance to Screening Colonoscopy: Randomized Study With Three Types of Invitations.

Maria Sklodowska-Curie National Research Institute of Oncology

A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group).

Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.

Each phone call will last approximately 5 minutes.

The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample.

A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group). Each phone call will last approximately 5 minutes.

Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.

Phone call

The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample

Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.

Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.

A Telephone Intervention to Improve Participation in a Screening Program.

Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial

Participation is defined as the number of people who do the screening test to the total of people invited to the Program.

proportion of people from the intervention group who report knowing the existence of the program.

proportion of people from the intervention group who report having understood in which the screening program consists of.

proportion of people from the intervention group who report that the information received in the phone call will be useful to decide about their participation in the program.

Corporacion Parc Tauli

Medical doctor specialist in Preventive Medicine and Public Health

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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

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.

Cedric RAT, Professor

Anne-Sophie BANASZUK, Doctor

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).

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.

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

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

Proportion of cytological tests performed among all screening tests

Proportion of HPV tests performed among all screening tests

Proportion of abnormal test results (cytology, HPV) among all screening tests performed

Proportion of "reflex" tests performed (number of cervical smears after a positive HPV result) among abnormal test results

Proportion of biopsies and conizations performed among abnormal screening test results

Proportion of high-grade lesions detected (second, a third-grade cervical intraepithelial neoplasia, including in situ carcinomas and cancers) among the abnormal screening tests

Percentages of treatments performed (conization, laser, hysterectomy) among the abnormal screening tests

Participation rate according to age (over 50), income (women with low incomes qualifying for basic health coverage) and comorbidities.

Proportion of women who resort to a GP, a midwife or a gynaecologist to undergo their screening test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy	NCT01182922	Colorectal Canc... Screening	Invitation lett...	55 Years - 64 Years	Maria Sklodowska-Curie National Research Institute of Oncology
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy	NCT01182922	Colorectal Canc... Screening	Invitation lett...	55 Years - 64 Years	Maria Sklodowska-Curie National Research Institute of Oncology
A Telephone Intervention to Improve Participation in a Screening Program.	NCT03082911	Colorectal Canc... Colorectal Neop...	Phone call Invitation lett...	49 Years - 70 Years	Corporacion Parc Tauli
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy	NCT01182922	Colorectal Canc... Screening	Invitation lett...	55 Years - 64 Years	Maria Sklodowska-Curie National Research Institute of Oncology
A Telephone Intervention to Improve Participation in a Screening Program.	NCT03082911	Colorectal Canc... Colorectal Neop...	Phone call Invitation lett...	49 Years - 70 Years	Corporacion Parc Tauli
Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women	NCT04689178	Cervical Cancer	Invitation lett... Invitation lett...	40 Years - 65 Years	Nantes University Hospital

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