Trial document




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  DRKS00005176

Trial Description

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Title

Development and Testing of a Decision Aid for Mammography Screening

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Trial Acronym

DAMS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

With the age of 50 years, every woman has a right to free participation in an X-ray examination for early detection of breast cancer (mammography screening). Every woman decides for herself whether she wants to have this examination or not. However, until today little is known about the reasons why women choose or choose not to participate.
Against this background, we want to investigate what factors are important for the decision. For this purpose, women over the age of 50 years will be targeted who get an invitation for screening for the first time. All women receive a link to an online questionnaire. One half is directed to an online decision aid for mammography screening, the other half directly to the questionnaire.
The study will collect information on the reasons for (non-)participation in mammography screening. In addition, we want to answer the question whether a decision aid is helpful for the decision. The results of the study will be used to improve information materials about mammography screening.

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Brief Summary in Scientific Language

Decision aids are interventions aiming to realise informed decisions. They are already used in many health-related decision-making contexts. This study aims to determine whether a decision is more informed when a decision aid about mammography screening is used and whether demographic factors have an impact. For this purpose, women over the age of 50 years will be targeted, who get an invitation for mammography screening for the first time. All women receive a link to an online questionnaire. The intervention group is directed to an online decision aid about mammography screening, the control group directly to the questionnaire.

The following questions will be examined:
(1) Does a decision aid increase the proportion of informed decisions?
(2) How does a decision aid affect the components of informed choice (knowledge, values/attitude, intention, implementation of intention)?
(3) Does a decision aid increase satisfaction with the decision?
(4) Does the effect of the decision aid differ based on certain demographic factors, different outcome groups of screening and time spent with the decision aid?
The results of the study will be used to improve information materials about mammography screening.

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Organizational Data

  •   DRKS00005176
  •   2013/07/29
  •   [---]*
  •   yes
  •   Approved
  •   2013-251-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   informed choice
  •   mammography screening
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Online Decision Aid for Mammography Screening
  •   Usual care
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

proportion of informed choices (questionnaire; T1 = at time of receiving the invitation to the mammography screening program; T2 = shortly after receiving the invitation to the mammography screening programme but before the indicated screening appointment; T3 = 3 months after receiving the invitation to the mammography screening program; arms 1 and 2)

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Secondary Outcome

knowledge, attitude, intention/participation-status (questionnaire; T1 = at time of receiving the invitation to the mammography screening program; T2 = shortly after receiving the invitation to the mammography screening programme but before the indicated screening appointment; T3 = 3 months after receiving the invitation to the mammography screening program; arms 1 and 2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2014/03/25
  •   740
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   50   Years
  •   50   Years
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Additional Inclusion Criteria

female, 50 years

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Exclusion Criteria

/

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Addresses

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    • Universität Bielefeld
    • Ms.  Prof. Dr.  Petra  Kolip 
    • Universitätsstr. 25
    • 33615  Bielefeld
    • Germany
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    • Universität Bielefeld
    • Mr.  JunProf. Dr.  Jacob  Spallek 
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universität Bielefeld
    • Ms.  Maren  Reder 
    • Universitätsstr. 25
    • 33615   Bielefeld
    • Germany
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    • Universität Bielefeld
    • Ms.  Maren  Reder 
    • Universitätsstr. 25
    • 33615  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • BARMER GEK
    • Lichtscheider Str. 89
    • 42285  Wuppertal
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/11/30
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Trial Publications, Results and other Documents

  •   Reder, M., & Kolip, P. (2015). Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial. BMC Women's Health, 15: 53. doi:10.1186/s12905-015-0210-5
  •   Reder M, Kolip P (2017) Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial. PLoS ONE 12(12): e0189148. https://doi.org/10.1371/journal.pone.0189148
  •   Reder, M., Soellner, R., & Kolip, P. (2019). Do Women with High eHealth Literacy Profit More from a Decision Aid on Mammography Screening? Testing the Moderation Effect of the eHEALS in a Randomized Controlled Trial. Frontiers in Public Health, 7, 46. doi: 10.3389/fpubh.2019.00046
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* This entry means the parameter is not applicable or has not been set.