Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006098

Trial Description

start of 1:1-Block title

Title

Saarland against colorectal cancer - Join in!

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SAMS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.sams.saarland.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Aim of the pilot project "Saarland against colorectal cancer - Join in!" (acronym: SAMS) is the testing and evaluation of a logistic uncomplex method to increase participation rate in colorectal cancer early detection. The project is conducted nationwide in Saarland, Germany. Both screening tests offered in the German statutory cancer screening program, testing for occult blood in the stool and screening colonoscopy, are included in the project. The project involves the implementation of key elements of an organized cancer screening program by repeated personal invitations and (in case of testing for blood in the stool) by sending of test materials.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

With approximately 65,000 new cases and 26,000 deaths per year colon cancer is the most common cancer and second leading cause of cancer death in Germany. A large proportion of these cases could be prevented through early detection. The German statutory cancer screening program offers two tests to detect cancer: testing for occult blood in the stool and screening colonoscopy. However, these tests are only used to a limited extend. In a nationwide pilot project in Saarland key elements of an organized screening program for colorectal cancer should be tested in the Saarland population. The primary aims of the study are the detection and quantification of the increase in participation rate by a personal invitation procedure and, in case of stool tests, by sending of test materials. Target population are people born in 1962 and in 1957 (N 34,000) in Saarland, who are identified by the national residents' registration file, and randomised to an intervention and control group within each birth year. In 2012, intervention groups received an information and invitation letter for colorectal cancer screening on their 50th or 55th birthday by the Saarland Health Minister. The focus in the younger population is testing for occult blood in the stool. One part of the younger population receives an information and invitation letter together with a blood test kit. The focus in the older population is screening colonoscopy. After one year, the personal invitation procedure is repeated. By the evaluated invitation procedure and the desired use of cancer screening tests, no additional risks for participants exist. The survey of the use and the results of investigations are carried out by the physicians' association and a study center. The evaluation of fecal occult blood tests is performed at the German Cancer Research Center (DKFZ). By means of control numbers (strings that are obtained from the identity data without recovery of the identity data), the billing data from the physicians' association can be linked with the data in the study center and analysed anonymously. The results of fecal occult blood tests are reported back from the DKFZ to the study center with a communication number that cannot be re-identified.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006098
  •   2014/04/23
  •   [---]*
  •   no
  •   Approved
  •   S-081/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

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
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Focus of the letter/writing addressed to the 50 year old group (two intervention groups of the birth year 1962) is testing for occult blood in the stool, which is paid by the health insurance from that age (and up to 55 years) annually. Beside the information about this offer and the invitation to its perception, the letter/writing should contain an understandable and clear information booklet about the test and its application and significance. In one of the two intervention groups, a stool test kit for carrying out the tests for blood in the stool should be additionally attached (test cards for each two samples from three consecutive bowel movements). It should be checked whether this "service offer" further increases participation rate in Germany, as shown in other countries. People in the intervention group 2 (cover letter with the stool test kit) will be asked to apply the test cards and send them to the DKFZ. There, the tests will be analysed and the result will be reported directly by mail to the persons and, if desired, additionally to the family doctor of whom the address is reported on a request form. In case of a positive test result, a meeting is recommended with the family doctor to discuss the possibility of a colonoscopic investigation. The test results are pseudonymised forwarded to the study center in the Saarland, where they can be clearly assigned to the investigation group 2 based on the communication numbers (which are noted on the materials sent to them). To check the benefits of repeated letters/writing of the same birth cohort, people are contacted again on the following 51th birthday (regardless of participation in the previous year). For this purpose there is a re-randomization, regardless of the assignment to the intervention and control groups in the first year. New stool test kits won't be sent as it can be expected that a part of the participants has already conducted such a test in the current calendar year. For these individuals, a further test in the same calendar year would not make sense, and there is also no claim thereto.
  •   Focus of the letter/writing to the 55 year old group (intervention group of the birth year 1957) is the screening colonoscopy, which is offered for the first time at that age. For this group, continuously updated information on the physicians entitled to screening colonoscopy should be additionally given. In case of not using the screening colonoscopy offer, the participant can use the stool test, however, no test kits are attached, therefore, the participant can obtain such a kit at the family doctor . To check the benefits of repeated letters of the same birth cohort, people are contacted again on the following 56th birthday (regardless of participation in the previous year). For this purpose there is a re-randomization, regardless of the assignment to the intervention and control groups in the first year.
  •   Control group without personal letter
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary aims of the pilot project are the detection and quantification of the increase in participation rate in colorectal cancer early detection through a logistic uncomplex personal invitation procedure. The issues include in particular:
- To what extent can the use of the test for occult blood in the stool be increased through a personal invitation letter with an information booklet?
- To what extend can the sending of a stool test kit together with the personal invitation letter further increase participation?
- To what extend is a colonoscopy performed in case of a positive test result?
- To what extend can the use of screening colonoscopy be increased through a personal invitation letter with an information booklet?
- What effects can be achieved in terms of participation at initial cover letter and follow-up letter in one year distance?
- For all questions: Are there differences between women and men?

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Discovered precancerous lesions and cancer diseases in various stages; expected long-term reduction in colorectal cancer mortality; cost-effectiveness. The issues include in particular:
- How many cases of colon cancer and its precancerous lesions can be additionally detected and removed early by the invitation? What effects can be expected in the long-term in terms of additional prevented colon cancer cases and cancer deaths through the invitation process?
- How is the cost-effectiveness of the test elements of an organized screening evaluated in terms of (i) the increase in the participation rate (ii) the expected long-term reduction in colorectal cancer incidence and mortality?
- For all questions: Are there differences between women and men?

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/05/02
  •   34000
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   55   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

General population of the Saarland (Germany), persons born 1962 and 1957

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

No general population of the Saarland (Germany); persons not born 1962 or 1957

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsches Krebsforschungszentrum (DKFZ)Abteilung Klinische Epidemiologie und Alternsforschung (C070)
    • Mr.  Prof. Dr.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Stiftung LebensBlicke
    • Mr.  Prof. Dr.  Jürgen F.  Riemann 
    • Schuckertstraße 37
    • 67063  Ludwigshafen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Kassenärztliche Vereinigung Saarland
    • Mr.  Dr.  Gunter  Hauptmann 
    • Europaallee 7-9
    • 66113  Saarbrücken
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und Alternsforschung (C070)
    • Mr.  Prof. Dr.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Ministerium für Gesundheit und Verbraucherschutz, Epidemiologisches Krebsregister Saarland
    • Ms.  Christa  Stegmaier 
    • Präsident-Baltz-Straße 5
    • 66119  Saarbrücken
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Gesundheit
    • Rochusstraße 1
    • 53123  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/04/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Ärztekammer des Saarlandes (2012) Saarland als Testregion für den Nationalen Krebsplan. Saarländisches Ärzteblatt, Ausgabe 4/2012: 27-8
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.