Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Breast Neoplasms

Uterine Cervical Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

Group 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings)

Intervention : Normal invitation

Group 2: Sending a revised invitation ( text, layout) signed by the coordinating doctor (send by the structure responsible for organized screenings)

Intervention : revised invitation signed by the coordinating doctor

Group 3: Sending a revised invitation signed by the attending physician (send by the structure responsible for organized screenings)

Intervention : Revised invitation signed by the attending physician

No modification and signed by the coordinating doctor as usual

Normal invitation

Invitation with revised text and layout and signed by the coordinating doctor as usual

revised invitation signed by the coordinating doctor

Revised invitation signed by the attending physician

Ken HAGUENOER

Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.

The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).

Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations

Randomized Trial Evaluating the Effectiveness of a "Targeted Communication" With the General Practitioner Involvement in Cancer Screening Invitation Letters

The participation / non participation will be measured for each cancer screening (breast, colorectal and cervical) :

* 9 months after the invitation letters for breast and colorectal cancers
* 12 months after the invitation letters for cervical cancer

The participation rate is defined as the number of people having participated, divided by the total number of people in the group or subgroup considered.

Analysis by comparing the participation rates between groups (Group 1, Group 2 and Group 3) and sub-groups will be done.

University Hospital, Tours

Breast Diseases

Skin Diseases

Eligible women will receive an invitation letter for a mammography accompanied by a leaflet mentioning the existence of the DA and encouraging them to consult their GP to initiate the DMP. The GPs will receive a letter informing them of the letter sent to their patients inviting them to make use of the DA, of the DA itself, and presenting the different stages in the DMP with encouragement to implement it.

Eligible women will receive only invitation letters, in line with national standard practice

At the beginning of the intervention, material i) informing women of the existence of the DA for participation or not in breast cancer screening and (ii) aiming to promote the implementation of shared medical decision will be sent or not sent to women and their GPs according to their allocation arm. This material will be sent at the same time as the breast cancer screening invitation letter.

For the secondary outcomes, questionnaires will be sent to a sample of women in each arm.

Leaflet "decidons ensemble" (making a decision together)

Cédric Rat, M.D. PhD.

Emilie Ferrat, M.D. PhD.

Sandrine Hild, M.D.

Shared decision-making for organised breast cancer screening could be improved by fostering interaction and exchanges of information between women and GPs, for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening (OS) for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website Discutons-mammo.fr DEDICACES project 1.

DEDICACES 2 is a pragmatic, non-inferiority, population-based trial with a cluster design. The aim is to assess the impact of the dispatch of a leaflet informing women of the existence of the DA Discutons-mammo.fr on the uptake by eligible women of breast cancer screening in an organised setting in usual practical conditions and in the general population

Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid

Shared Decision-making for Breast Cancer Screening in Primary Care

Participation rate for organised screening for breast cancer in each study arm for the 18 months after dispatch of the letter

Participation rate for organised breast cancer screening, in each study arm for the 18 months after dispatch of the letter, according to patient age, socio-economic status, regularity of medical surveillance, the presence of chronic or psychiatric pathologies and previous participation in screening

Scores for the 9-items Shared Decision Making Questionnaire. (5 response categories ; number 1 = completely disagree ; number 5 = completerly agree ; higher scores mean better outcome).

Scores for the 16-items Decisionnal Conflict Scale. (5 response categories ; number 1 = strongly agree ; number 5 = strongly disagree ; higher scores mean worse outcome).

Responses to the intention to participate in screening Questionnaire (Questionnaire developed for the project ; 4 response categories = yes, no, don't know, don't want to answer).

Responses to the knowledge questionnaire on organized screening (Questionnaire developed for the project ; 20 items , 3 response categories = true, false, dont know).

National Cancer Institute, France

Nantes University Hospital

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.

Invitation letter

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
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations	NCT02367001	Breast Cancer Colorectal Canc... Cervical Cancer	Normal invitati... revised invitat... Revised invitat...	25 Years - 74 Years	University Hospital, Tours
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations	NCT02367001	Breast Cancer Colorectal Canc... Cervical Cancer	Normal invitati... revised invitat... Revised invitat...	25 Years - 74 Years	University Hospital, Tours
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations	NCT02367001	Breast Cancer Colorectal Canc... Cervical Cancer	Normal invitati... revised invitat... Revised invitat...	25 Years - 74 Years	University Hospital, Tours
Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid	NCT05607849	Breast Cancer	Leaflet "decido...	50 Years - 74 Years	Nantes University Hospital
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
Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid	NCT05607849	Breast Cancer	Leaflet "decido...	50 Years - 74 Years	Nantes University Hospital

Spots Global Cancer Trial Database for organized screening