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Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid (DEDICACES2)

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Leaflet "decidons ensemble" (making a decision together)
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Breast cancer screening, Organized screening, General practitioner, Randomized controlled trial, Shared medical decision-making, Decisional aid, Primary health care

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: General practitioners (GP) All GPs practising in the 5 French departements Maine-et-Loire, Mayenne, Sarthe, Loire Atlantique and Vendee having seen more than 100 different patients in the year before baseline, will be eligible. Patients aged de 50 to 74 yrs affiliated to the French health insurance CPAM residing in one of the 5 departments eligible for organised screening for the month(s) under consideration whose GP is included in the study Exclusion Criteria: General practitioners (GPs) : Refusal to participate Participants in other studies on breast cancer screening Practising in a health centre Patients Refusal to participate Having a GP who refuses to take part Affiliated to a Health Centre Taking part in other studies on breast cancer screening Being under guardianship Presently followed for a condition that might interfere with organised screening (breast cancer, anomaly, medical surveillance or women with high risk Having a history of breast cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Decisional aid for organised cancer screening

    Standard organised cancer screening

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Description of the factors associated with lower participation in screening
    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
    Description of the implementation and the quality of shared decision processes for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent 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).
    Description of the existence of decisional conflict for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    Scores for the 16-items Decisionnal Conflict Scale. (5 response categories ; number 1 = strongly agree ; number 5 = strongly disagree ; higher scores mean worse outcome).
    Description of intention to take part in organised screening for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    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).
    Description of the level of knowledge about organised screening for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    Responses to the knowledge questionnaire on organized screening (Questionnaire developed for the project ; 20 items , 3 response categories = true, false, dont know).

    Full Information

    First Posted
    October 24, 2022
    Last Updated
    November 2, 2022
    Sponsor
    Nantes University Hospital
    Collaborators
    National Cancer Institute, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05607849
    Brief Title
    Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid
    Acronym
    DEDICACES2
    Official Title
    Shared Decision-making for Breast Cancer Screening in Primary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nantes University Hospital
    Collaborators
    National Cancer Institute, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Breast cancer screening, Organized screening, General practitioner, Randomized controlled trial, Shared medical decision-making, Decisional aid, Primary health care

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Decisional aid for organised cancer screening
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard organised cancer screening
    Arm Type
    No Intervention
    Arm Description
    Eligible women will receive only invitation letters, in line with national standard practice
    Intervention Type
    Other
    Intervention Name(s)
    Leaflet "decidons ensemble" (making a decision together)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Participation in organised screening for breast cancer
    Description
    Participation rate for organised screening for breast cancer in each study arm for the 18 months after dispatch of the letter
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Description of the factors associated with lower participation in screening
    Description
    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
    Time Frame
    18 months
    Title
    Description of the implementation and the quality of shared decision processes for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    Description
    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).
    Time Frame
    4 months
    Title
    Description of the existence of decisional conflict for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    Description
    Scores for the 16-items Decisionnal Conflict Scale. (5 response categories ; number 1 = strongly agree ; number 5 = strongly disagree ; higher scores mean worse outcome).
    Time Frame
    4 months
    Title
    Description of intention to take part in organised screening for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    Description
    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).
    Time Frame
    4 months
    Title
    Description of the level of knowledge about organised screening for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening
    Description
    Responses to the knowledge questionnaire on organized screening (Questionnaire developed for the project ; 20 items , 3 response categories = true, false, dont know).
    Time Frame
    4 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: General practitioners (GP) All GPs practising in the 5 French departements Maine-et-Loire, Mayenne, Sarthe, Loire Atlantique and Vendee having seen more than 100 different patients in the year before baseline, will be eligible. Patients aged de 50 to 74 yrs affiliated to the French health insurance CPAM residing in one of the 5 departments eligible for organised screening for the month(s) under consideration whose GP is included in the study Exclusion Criteria: General practitioners (GPs) : Refusal to participate Participants in other studies on breast cancer screening Practising in a health centre Patients Refusal to participate Having a GP who refuses to take part Affiliated to a Health Centre Taking part in other studies on breast cancer screening Being under guardianship Presently followed for a condition that might interfere with organised screening (breast cancer, anomaly, medical surveillance or women with high risk Having a history of breast cancer
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cédric Rat, M.D. PhD.
    Phone
    02 40 41 28 28
    Email
    cedric.rat@univ-nantes.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emilie Ferrat, M.D. PhD.
    Email
    emilie.ferrat@u-pec.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cédric Rat, M.D. PhD.
    Organizational Affiliation
    Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sandrine Hild, M.D.
    Organizational Affiliation
    Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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