Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004271

Trial Description

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Title


What influence do information brochures have on the decision-making of women to take part in mammographic screening?

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Trial Acronym

MaScE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Since summer 2010 in Germany there is a new information brochure for mammography screening. While the old brochure did hardly contain any relevant information for screening (it was more promoting screening), the new brochure provides information to the reader that enables her to make an “informed decision”. We would like to find out if after reading the new brochure women have more knowledge on facts about screening than after reading the old brochure, and if this knowledge influences the willingness to attend screening. The study will be carried out in GP’s surgeries, and one group of women will read the old brochure, one group the new one. Both groups will fill out a questionnaire on comprehension of facts about mammography screening, and on the willingness for attending the screening. Women at the age oft 48-49y are included into the study, this is just before they are invited officially for screening for the first time.

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Brief Summary in Scientific Language

Since September 2010 an information brochure is sent to women when they are invited for mammographic screening together with the invitation letter, which contains considerable more significant information regarding benefits and risks of the screening than previously sent brochures, thus offering a better basis for an informed decision.
There is no such information brochure in other countries yet that informs as comprehensively as ours. An argument against comprehensive information is the worry that the number of participants might decrease due to the small individual benefit. The aim of the study is to find out whether women are less interested in taking part in the screening after reading the “new” brochure than after reading the “old” brochure. Additionally, we would like to find out whether there is more knowledge about the screening in one group, and whether there are other influencing factors for or against the participation in the screening.

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Organizational Data

  •   DRKS00004271
  •   2012/08/27
  •   [---]*
  •   yes
  •   Approved
  •   3797, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   Mammography screening, patient information
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Interventions/Observational Groups

  •   Completion of a questionnaire after reading the new information brochure for mammography screening
  •   Completion of a questionnaire after reading the old information brochure for mammography screening
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, data analyst
  •   Active control
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Percentage of the expressed willingness of participation compared to the group with the new brochure (Group A) versus the group with the old brochure (Group B).

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Secondary Outcome

Multivariable analysis of willingness to participate depending on knowledge, personal experience, the kind of brochure, demographic variables, and influences through the media

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/15
  •   350
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   48   Years
  •   49   Years
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Additional Inclusion Criteria

women of the eligible age who are able to read and understand German.

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Exclusion Criteria

Women who are not oble to read or understand German or are mentally disordered, and women of whome it is known they have had breast cancer.

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Addresses

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    • Institut für Allgemeinmedizin Universitätsklinikum Düsseldorf
    • Ms.  Dr.  Elisabeth  Gummersbach 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Institut für Allgemeinmedizin Universitätsklinikum
    • Ms.  Dr.  Elisabeth  Gummersbach 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Institut für Allgemeinmedizin Universitätsklinikum
    • Ms.  Dr.  Elisabeth  Gummersbach 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Allgemeinmedizin Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    •   0211 8117771
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/05/28
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.