Trial document





This trial has been registered retrospectively.
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  DRKS00006268

Trial Description

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Title

Use and results of screening colonoscopy at 50 to 54 year old women and men

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Since October 2002, the colonoscopy is part of the statutory cancer screening in Germany and can be taken by the insured from the age of 55. Age-specific analysis, however, show relevant incidence rates of colorectal cancer already from the age of 50 years. Therefor, the two statutory health insurances AOK Baden-Wuerttemberg and Bosch BKK offer a model project in screening colonoscopy starting at the age of 50, as required in the S3 guideline colon cancer.
For this, differently designed invitation letter are used. Pseudonymous data of this pilot project will be analyzed in this study.
The goal is to find out how the offer of screening colonoscopy is claimed in 50-54 year-old women and men and what factors are associated with the claim. In particular, the influence of differently designed invitation letter should be analyzed. In addition, further statistical-epidemiological analyses should provide insights into the relevance of colorectal cancer screening in this age group. For example, the prevalence of colorectal carcinoma and its precursors (adenomas) shoueld be determined.
For the analyses, only pseudonymous data collected and provided by the health insurances will be used. In the planned research, 50-54 years old insured are included who participated in the HausarztProgramm HZV (Hausarztzentrierte Versorgung) (N currently about 70,000).

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Brief Summary in Scientific Language

With about 65,000 new cases and 26,000 deaths per year colorectal cancer is the most common cancer and second leading cause of cancer death in Germany. Since October 2002, insured by the statutory health insurance in Germany are entitled to take part at the colorectal cancer screening and prevention as performance of the health insurances from their 50th or 55th birthday. From the age of 50 every insured is annualy offered a fecal occult blood test. From the 55th birthday this offer is only in 2-year intervals. As an alternative screening measure, a colonoscopy can be claimed from the 55th birthday. If first claims are before age 65, a recurrence is offered after 10 years.
Despite intensive public relations and motivation campaigns, including by the Stiftung Lebensblicke and the Felix Burda Stiftung, however, the rates of participation in colorectal cancer screening remained disappointingly low. Each year, only slightly less than 3% of eligible women and men used the offer of screening colonoscopy, extrapolated to a period of 10 years (which is recommended as a screening interval for colonoscopy by the professional associations), these are about 20-30%.
One possibility to increase the participation rate is the introduction of an organized screening by personal invitation. As part of a pilot project, the two statutory health insurances AOK Baden-Wuerttemberg and Bosch BKK in cooperation with the MEDIVERBUND specifically invite insured between the ages of 50 and 54 years to a screening since spring 2014. For this, randomized differently designed invitation letter are used. One sub-group of addressees receives a risk-check enabling the identification of specific risk groups. The results of screening colonoscopy are recorded by the treating physicians in a standardized format and in case of an explicit written consent of the patient forwarded together with the billing to the MEDIVERBUND and there integrated in a pseudonymous data set for the purpose of quality assurance and scientific monitoring.
The primary objectives of the study are to investigate the use of a screening colonoscopy at 50-54 year olds and the analysis of the factors that are associated with the claim. In particular it should be analyzed whether the addition of the invitation letter of a risk-check improves participation as a whole and especially of the risk groups and thus leads to an increased rate of detection of colorectal neoplasia. In addition, further statistical-epidemiological analyses are carried out, providing important information on the relevance of colorectal cancer screening in 50-54 year-old women and men. Their results will contribute to further improve the early detection of colorectal cancer.
The statistical analyses are carried out in the Department of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ) in Heidelberg.
Target population are 50-54 years old insured of the two statutory health insurances AOK Baden-Wuerttemberg and Bosch BKK who participate in the HausarztProgramm HZV (Hausarztzentrierte Versorgung) (N currently about 70,000). These are identified by the health insurances and contacted since spring 2014 (information and invitation letter to colorectal cancer screening from age 50). For this, two randomized groups are formed by the health insurances: one group receives only an information and invitation letter (control group), the other group will also receive a 1-minute risk self-check for colon cancer (intervention group).
By the evaluated invitation process and the desired use of cancer screening tests no additional, on participation in the statutory cancer screening excess risks exist for relevant personnel.

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Organizational Data

  •   DRKS00006268
  •   2015/11/17
  •   [---]*
  •   yes
  •   Approved
  •   S-513/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   K62.1 -  Rectal polyp
  •   K63.5 -  Polyp of colon
  •   D12.2 -  Benign neoplasm: Ascending colon
  •   D12.3 -  Benign neoplasm: Transverse colon
  •   D12.4 -  Benign neoplasm: Descending colon
  •   D12.5 -  Benign neoplasm: Sigmoid colon
  •   D12.6 -  Benign neoplasm: Colon, unspecified
  •   D12.7 -  Benign neoplasm: Rectosigmoid junction
  •   D12.8 -  Benign neoplasm: Rectum
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Interventions/Observational Groups

  •   Circular of the respective health insurance companies at their 50-54 years old insured persons. Besides the information about the offer of screening colonoscopy from the age of 50 and the invitation to its awareness, the letter contains a one-minute risk self-check for colorectal cancer (intervention group).
  •   Circular of the respective health insurance companies at their 50-54 years insured persons. The letter includes information about the offer of screening colonoscopy from the age of 50 and invitation to its awareness. The letter does not contain a one-minute risk self-check for colorectal cancer (control group).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Increase of colorectal neoplasm detection rates through an invitation letter containing a risk self-check compared to an invitation letter without risk self-check.

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Secondary Outcome

• Participation rates in screening colonoscopy after invitation letter with and without risk self-check and depending on further factors.

• Detection rates of different colorectal neoplasms (carcinomas, advanced adenomas, non-advanced adenomas)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/04/01
  •   70000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   54   Years
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Additional Inclusion Criteria

• Insured persons of the respective health insurance companies participating in the HZV-treaty (§ 73b SGB V) since 01.April 2014 or earlier

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Exclusion Criteria

1.) Letter from the respective health insurance companies to participants:

• Deceased insured persons

• Insured persons who have a nursing level

• Insured persons with any kind of cancer diagnoses during insurance benefit (ICD = C*, D0*, D37*, D38*, D39*, D40*, D41*, D42*, D43*, D44*, D45*, D46*, D47*, D48*, D53*, D54*, D55*, D56*, D57*, D58*, D59*, D6*, D7*, D8*, D90*, Guaranty= Secured/condition after)

• Insured persons where a curative colonoscopy has already been performed

2.) Analyses at the DKFZ:

• Incorrect or implausible data to essential features in the data set

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Addresses

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    • AOK Baden-Württemberg
    • Heilbronner Str. 170
    • 70191  Stuttgart
    • Germany
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    •   [---]*
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    • Bosch BKK
    • Kruppstr. 19
    • 70469  Stuttgart
    • Germany
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    • MEDIVERBUND Baden-Württemberg
    • Mr.  Jens  Offenhäußer 
    • Industriestr. 2
    • 70565  Stuttgart
    • Germany
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    • Deutsches Krebsforschungszentrum (DKFZ) Abteilung Klinische Epidemiologie und Alternsforschung (C070)
    • Mr.  Prof. Dr.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • AOK Baden-Württemberg
    • Mr.  Stefan  Meny 
    • Heilbronner Str. 170
    • 70191  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Krebsforschungszentrum (DKFZ) Abteilung Klinische Epidemiologie und Alternsforschung (C070)
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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