Dataset Information

Increase of the usage and effectiveness of colorectal cancer screening by means of targeted invitations with and without providing fecal immunochemical tests

ABSTRACT: Interventions: Group 1: Group A = Insured persons in group A receive a personal invitation letter from the AOK-BW, which describes early detection measures of colorectal cancer, invites them to carry out a quantitative FIT (fecal immunochemical tests) and additionally already includes such a test. Group 2: Group B = Insured persons in group B receive a personal invitation letter from the AOK-BW, which describes early detection measures of colorectal cancer, invites them to carry out a quantitative FIT and also provides the option to order such a test for free (by mail, fax, internet) at the DKFZ. Group 3: Group C (control group) = Insured persons in group C receive a personal letter from the AOK-BW, which describes early detection measures of colorectal cancer, but they are neither automatically provided a quantitative FIT nor can they order it at the DKFZ. However, within the regular care, the insured persons can take precautionary measures if they are interested. Thus, the measures in group C (providing regular, insurance-related information, recording the use of precautionary measures in the regular care) are carried out within the framework of normal, already existing procedures and are independent of the study. Primary outcome(s): The primary endpoint is the usage rate of the test offer after receiving an invitation letter, as well as the usage rate of the test offer after recieving an invitation letter with subsequent reminder in comparison to the one-time letter, respectively within one year after the initial letter. Study Design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: screening

DISEASE(S): Colon, Unspecified,Malignant Neoplasm Of Rectum,Transverse Colon,Polyp Of Colon,Malignant Neoplasm Of Rectosigmoid Junction,Descending Colon,Willingness To Perform A Stool Blood Test For Colorectal Cancer Screening After Sending Out Different Invitation Letterswillingness To Perform A Colonoscopy After A Positive Stool Test Result,Malignant Neoplasm Of Colon,Ascending Colon,Rectum,Rectosigmoid Junction,Sigmoid Colon

PROVIDER: 2432933 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Group 1: 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 cont 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? Study Design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: Other; Assignment: other; Study design purpose: prevention

Project description:Interventions: Name of intervention: gender specific mail-administered screening invitation strategies. All participants will receive an offer to participate in a free FOBT which will be delivered by mail. Intervention arms will differ from control according to the information included in the materials accompanying the screening offer. All study participants will receive a standard screening reminder irrespective of their intervention group. Intervention materials will target specific psychosocial variables previously identified as being related to male participation in FOBT screening. The intervention period is 14 weeks. All participants will receive a screening offer according to the following timeline. Baseline: Advance notification letter sent Week two: Invitation package sent Week eight: Reminder letters sent to those who have not completed an FOBT Week 14: Data collection ceases. Arm 1: Control The control arm will receive a standard offer to participate in FOBT screening designed to mimic the strategy utilised by the Australian national bowel cancer screening program (NBCSP). The standard offer includes an advance notification letter and a screening invitation package. The advance notification letter is sent two weeks prior to the screening invitation package and is designed to alert participants that an invitation to screen for CRC with an FOBT will soon follow. The standard advance notification letter introduces basic information about colorectal cancer and the health benefits of screening. The screening invitation package includes a) a screening invitation letter b) an immunochemical FOBT with associated instructions c) an information booklet that describes colorectal cancer and screening and d) a particip Primary outcome(s): Rate of FOBT participation per trial arm as assessed by number of FOBT screening tests returned.[At 14 weeks from baseline, 12 weeks after receiving the FOBT.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy

Project description:Participants will be mailed an invitation to complete CRC screening along with a fecal immunochemical test (FIT) kit, containing a 1-sample "Polymedco Over the Counter (OC) Sensor FIT", simplified English/Spanish instructions on performing the test, educational information about colorectal cancer screening and a return mailer with prepaid postage. Processes that will be used to promote screening completion include automated and "live" phone call reminders to encourage completion of FIT testing. Participants will be randomly assigned to 1 of 5 interventions across 3 conditions, described below: 1. Condition 1 (Standard Intervention): * Branch I: Participants assigned to the control condition will receive a FIT kit and the standard invitation letter to participate in free screening. 2. Condition 2 (Time Guideline): * Branch II: Participants will receive a FIT kit and invitation letter to participate in free screening with a 1-week time restriction. * Branch III: Participants will receive a FIT kit and invitation letter to participate in free screening with a 3-week time restriction. 3. Condition 3 (Time Guideline + Incentive): * Branch IV: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive. * Branch V: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" (same as lower in Branch IV) monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive. Participants with a normal test result will receive a personal letter confirming this with invitations to complete a repeat screening in subsequent year(s). Participants receiving an abnormal FIT result will be navigated to complete a diagnostic colonoscopy. Participants continuing in the screening program in subsequent years will receive letters emphasizing the importance of repeat screening to prevent adverse CRC outcomes.

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Increase of the usage and effectiveness of colorectal cancer screening by means of targeted invitations with and without providing fecal immunochemical tests

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