Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

This group will be screened with the risk-based model. The input of the model will be gathered with the FIT, a validated questionnaire, and from data of the Dutch general population registry. The threshold of the model will be set at a calculated risk of 0.10. To comply with ethical guidelines, all participants in this group with a FIT result of \>=15 mcg Hb/g faeces and a calculated risk of \<0.10 will also be offered a colonoscopy.

This group will be screened with the FIT. The threshold of the FIT will be set at \>= 15 mcg Hb/g faeces.

The intervention will be a risk-based logistic regression model that takes multiple variables into account to calculate the risk of advanced neoplasia as an outcome.

Risk-based logistic regression model

FIT is a stool-based test that detects human blood in faeces.

Evelien Dekker, PhD MD

Colorectal Carcinoma (CRC) is the third most frequent diagnosed cancer worldwide, with 1.4 million new cases every year. In an attempt to reduce this number many countries have implemented a nationwide screening programme targeted at detecting CRC in an early phase using fecal immunochemical tests (FITs). People with an elevated level of blood in their stool are offered a colonoscopy, an invasive medical procedure where CRCs and premalignant lesions (together also referred to as advanced neoplasia) can be detected accurately.

However, the current screening method using FIT is not optimal. In FIT-based CRC screening studies, 1 in 4 participants with CRC and 2 in 3 participants with advanced neoplasia receive a negative FIT result. In contrast, an estimated 1 in 2 FIT-positives have advanced neoplasia at colonoscopy.

Recent studies have demonstrated that a risk model that takes into account the FIT result and other risk factors for CRC could enhance the effectiveness of a FIT-based CRC screening programme.

The objective of this study is to assess the yield of advanced neoplasia in the colon and rectum of a FIT-based risk model at colonoscopy, compared to that of a FIT-only CRC screening strategy. Our hypothesis is that a risk-based model yields significantly more advanced neoplasia at colonoscopy than the FIT by itself, and that it does not affect participation rate.

To assess this hypothesis, the investigators have designed a clinical trial in which the investigators randomize 23,000 asymptomatic individuals between the age of 55 and 75 years old to either risk-based screening (intervention group) or FIT-only screening (control group). The intervention group will receive a questionnaire on risk factors of CRC (e.g. smoking, family history of CRC), and a FIT. The control group will only receive the FIT. The positivity threshold of the FIT in both groups will be set at 15 micrograms haemoglobin per gram faeces. The positivity threshold of the risk-based model in the intervention group will be set at 0.10 (out of a range of 0 to 1), a threshold that is calculated with a goal to match the positivity rate of the control group.

Participants with a result that is above the thresholds of the FIT and/or the risk-based model will be invited to undergo a colonoscopy according protocol of the Dutch national screening program. After the study has ended, the investigators will compare both groups to assess our hypotheses.

INTRODUCTION AND RATIONALE Colorectal Cancer (CRC) is the third most frequent diagnosed cancer worldwide, with 1.4 million new cases every year. Mortality of CRC is estimated at around 40%. To reduce the incidence of CRC and to abate the negative consequences associated with CRC, methods for early detection of (pre)malignant colorectal lesions have extensively been researched and implemented. Colonoscopy is the reference standard for the detection of advanced neoplasia, but it requires trained endoscopists, carries a high burden, harbours a risk for complications in patients, and increases societal costs.

Most screening programs use methods to select screening participants with a high risk of advanced neoplasia for colonoscopy. One such method is the detection of blood in stool with faecal immunochemical tests (FITs).

Multiple nation-wide screening programs have now been implemented using FIT, including one in the Netherlands. In the Dutch CRC screening program, using a FIT threshold of 47 µg Hb/g faeces, the sensitivity of FIT in detecting CRC is 85.5%. The sensitivity of FIT in detecting advanced neoplasia (AN) is however substantially lower: 38%.

FIT-based screening also generates a high number of false positives, leading to unnecessary colonoscopies and distress for those patients. Approximately 1 in 2 FIT-positives has advanced neoplasia; the first round of the Dutch CRC screening program, using a FIT threshold of 47 µg Hb/g faeces, reached a positive predictive value of 54%.

Previous studies have demonstrated the existence of clinical risk factors for CRC, such as male gender, age, family history of CRC, and smoking. In a ZonMW sponsored project (ZonMW 50-50115-96-521) our group has shown that higher age, male sex, a family history with close relatives in whom CRC was diagnosed, and active smoking were all associated with the presence of advanced neoplasia (Stegeman et al, Gut, 2014).

Multiple CRC risk models have been developed using these risk factors, but most show only weak discriminatory power. Others have proposed risk models that additionally included molecular markers, increasing performance and discriminatory power, but these markers can be cumbersome to collect and can be costly in respect to the relative cheap FIT test. the investigators propose to combine CRC risk factors with the quantitative FIT result. FIT is a quantitative test with a variable cut-off level, and individuals with higher values of faecal haemoglobin are at higher risk of having advanced neoplasia at the cost of a lower specificity. Therefore, the quantitative result can be used as a weight-factor in a risk model.

Based on information on these risk factors for CRC and the quantitative FIT-result, our FIT-based risk model for CRC screening calculates the personal risk of having advanced neoplasia at colonoscopy. Inviting screening participants with elevated risk for colonoscopy, rather than those whose FIT result exceeds a pre-specified threshold, has the potential to increase the effectiveness and efficiency of FIT-based CRC screening. However, this requires participants to complete the questions about risk.

Our hypothesis is that integration of FIT score with known risk factors (age, gender, smoking, and family history of CRC) improves the number of participants in whom advanced neoplasia is detected, relative to the number of invitees. The investigators will compare a risk-based approach to screening, as described above, to the conventional FIT-only screening in a randomized controlled screening trial.

OBJECTIVES The study hypothesis is that risk-based CRC screening significantly outperforms FIT-only CRC screening in terms of the relative number of invitees in whom advanced neoplasia is detected at colonoscopy.

Primary Research Question: does risk-based CRC screening result in a higher relative number of invitees in whom advanced neoplasia is detected at colonoscopy compared to FIT-only CRC screening?

Secondary Research Questions:

i) Does risk-based CRC screening result in a higher standardized screening yield in whom advanced neoplasia is detected at colonoscopy compared to FIT-only CRC screening? ii) Is the participation rate of risk-based CRC screening non-inferior compared to FIT-only screening? iii) Does risk-based CRC screening result in a higher relative number of invitees in whom advanced neoplasia is detected at colonoscopy compared to FIT-only CRC screening at higher FIT-positivity thresholds (from 15 µg Hb /g faeces)? iv) Does risk-based CRC screening result in a higher relative number of invitees in whom proximally located advanced neoplasia is detected at colonoscopy compared to FIT-only CRC screening?

METHODS The investigators will perform a randomized controlled trial in 23,000 randomly selected men and women (aged 55 to 75 years) eligible for participation in the national CRC screening programme. All eligible participants will be second time invitees, living within a 25 km radius from the colonoscopy centre Bergman Clinics Amsterdam, which is accredited for the national population screening program.

Eligible individuals are randomly allocated on a 1:1 basis to an invitation for either risk-based CRC screening (intervention group) or FIT-only screening (control group). Randomization per household will be done before invitation. Study invitations are sent out by Foundation of Population Screening Mid-West (BoMW) early November 2019 before sending the FIT sample kit of the national screening program to the study cohort from January 2020 to April 2020. The study invitation is combined with a leaflet containing information on study participation. It will also contain an informed consent form, and a one-page questionnaire (if allocated to the intervention arm) with a self-addressed envelope to the research facility. The informed consent form will bear a unique study identification code.

The model that the investigators will use in this study for risk-based screening is derived from a model developed in a primary colonoscopy screening trial (Stegeman et al, Gut, 2014). The investigators have re-evaluated our multivariable risk model for CRC, with the aim to simplify it for daily practice. A number of risk factors (such as elements from diet) added little to the performance of the model, whereas collecting the necessary information proved rather tedious. The quantitative FIT result, age, sex, family history and smoking behaviour were the most decisive factors in the model.

This simplified FIT-based risk model had a performance like that of the extended model in the development dataset. In this study the investigators will calculate the risk of harbouring advanced neoplasia with our simplified FIT-based risk model, based on the quantitative FIT result, age, sex, family history and smoking behaviour (see below). The threshold and expected positivity rate of the risk-based model will be matched to the expected positivity rate of the FIT-only group.

Regression equation of the updated model:

ln(odds AN) = -4.955073942+0.9196052173\*Smoking+0.3364761549\* √FIT+0.370575346\*family history of CRC-0.006934851\*FIT+0.0228752117\*age+0.070972656\*gender

Probability of advanced neoplasia:

P (AN)=e\^((odds AN))/(1+e\^((odds AN))) If invitees that are allocated to the intervention group (i.e. questionnaire and FIT) only return the questionnaire, they do not qualify for a colonoscopy. When consenting invitees in the intervention group prefer not to complete the questionnaire, FIT tests will be analysed at a cut-off of 15 µg Hb/g faeces.

The type of FIT that will be used is the one used in the Dutch national screening programme: FOB-Gold (Sentinel, Italy). FIT-analyses and sending of FIT results will be performed according to the logistics as being used in the national screening. The FIT result and the result of the questionnaire will be entered in a database, to calculate the participant's risk. All FIT positives (≥15 µg Hb/g faeces) will be referred for consultation for colonoscopy at regional endoscopic centres. For the purpose of this study, FIT-negative but risk-positive participants (i.e. the combination of the results of the questionnaire and the quantitative FIT result) will also be invited for consultation for colonoscopy.

Colonoscopy will be performed by endoscopists accredited for our national screening programme and according to national and international quality guidelines. Quality indicators and endoscopic findings will be systematically recorded in a database, according to the standards of the national screening programme. Lesions will be immediately removed, if possible, and otherwise biopsies will be obtained. Histopathological assessment of these tissue samples will provide a definitive diagnosis. Data on location, size, macroscopic aspect, morphology and polypectomy will be recorded for all colonic lesions, which will be collected and evaluated by an accredited GI-pathologist according to the Vienna criteria. Advanced adenomas are defined as adenomas larger than 10 mm, adenomas with high-grade dysplasia or adenomas with a villous component of at least 25%. Advice regarding surveillance colonoscopy after removal of adenomatous polyps, large (≥10 mm) serrated lesions or cancer will be given to the clients according to the Dutch CBO consensus.

Screening invitees can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a screening invitee from the study for urgent medical reasons.

STATISTICAL ANALYSIS

Primary outcome The difference in screening yield will be estimated and expressed as an absolute difference per 1,000 invitees, with 95% confidence intervals. The investigators will test the null hypothesis of no difference in yield between the intervention and control group using the chi-square test.

Secondary outcome The standardized screening yield will be calculated by ranking participants according to their calculated risk (in risk-based screening) and comparing the yield of risk-based screening for the number of positives that matches the number of FIT-positives with FIT-only screening with a chi-square test. Additionally, the investigators will use the McNemar test statistic to test the null hypothesis of no gain in screening yield in the intervention group only, where the investigators can compare referrals based on FIT only with referrals based on FIT and calculated risk.

The participation rate will be calculated through the number of participants relative to the number of invitees in each arm. Differences in participation rate will be assessed using the chi square test. The difference in screening yield of proximally located advanced neoplasia between both arms will be estimated and expressed as an absolute difference per 1,000 invitees (with 95% confidence intervals). The null hypothesis of no difference in yield will be tested using the chi square test.

Statistical significance level P-values of lower than 0.05 will be considered statistically significant. All analysis between both arms are based on the intention-to-screen principle, unless stated otherwise. Statistical analyses will be performed using R.

Additional outcomes Model performance in comparison to the FIT will be assessed with the net reclassification improvement (NRI). In addition, the yield of the FIT-based risk model and the FIT will be assessed at a broad range of FIT thresholds and will be estimated and expressed as the number of detected advanced neoplasia per 1,000 invitees (intention-to-screen) and per 1,000 colonoscopies (per protocol). Differences in the yield will be tested using a chi square test. Any missing data that was intended to be used as input for the risk-model, will be classified as '0'.

ETHICAL CONSIDERATIONS The study will be conducted according to the principles of the Declaration of Helsinki (Version October 2008) and the Population Screening Act (WBO). Permission to conduct this study has been granted by the Dutch Health Council and the Dutch Minister of Healthcare.

The researchers conduct a parallel group randomized controlled trial. Asymptomatic individuals will be randomized to either risk-based screening or FIT-only screening.

Combining Risk Factors and Faecal Immunochemical Testing in Colorectal Cancer Screening: a Randomized Controlled Trial

Conditional on the permission of the Dutch government, anonymized research data may be shared after publication of the results in a peer-reviewed paper.

The primary outcome is the yield of advanced neoplasia, defined as the relative number of invitees in whom advanced neoplasia is detected at colonoscopy.

standardized screening yield: ranking the number of participants according to their calculated risk and comparing the yield of risk-based screening for the number of positives that matches the number of FIT-positives with FIT-only screening.

participation rate, defined as the relative number of invitees participating in screening.

yield of advanced neoplasia, defined as the relative number of invitees with advanced neoplasia detected at colonoscopy, at FIT-positivity thresholds of 15 µg Hb/g faeces and higher.

yield of proximally located advanced neoplasia, defined as the relative number of referred participants in whom proximally located advanced neoplasia is detected at colonoscopy.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Professor

Colonic Neoplasms

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.

3 sample g-SENSA

Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.

2 sample InSure

Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.

1 sample OC-Micron

Beverly B Green, MD,MPH

Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time.

Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.

Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Fred Hutchinson Cancer Center

University of Washington

Kaiser Permanente

Immune System Diseases

Hypersensitivity

CRC diagnosed in the population excluded from screening

CRC diagnosed after a positive fecal immunochemical test (FIT)

CRCs diagnosed after a positive fecal immunochemical (FIT) test, but without colonoscopy or \> 2 years after a positive fecal immunochemical test

CRCs diagnosed 2 years after a negative FIT

CRCs diagnosed in the FIT non-responders population

CRCs diagnosed within 5 years after a colonoscopy performed following a positive test that did not find colorectal cancer

We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.

Positive fecal immunochemical test (FIT)

Negative fecal immunochemical test (FIT)

Fecal immunochemical test (FIT) not performed

Michel ROBASZKIEWICZ

Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective was to evaluate the sensitivity of FIT and the proportion of interval cancer.

Fecal immunochemical test (FIT) aims to detect pre-symptomatic lesions, i.e., early stage colorectal cancers (CRCs) or pre-cancerous lesions such as colonic adenomas in order to reduce CRC mortality. FIT was introduced in France late 2015, FIT has better diagnostic accuracy for CRCs than previous screening tests. Determining the incidence of post-test interval CRCs, diagnosed after a negative FIT and before the recommended date of the next test (2-year interval), allows assessment of the sensitivity of the test. The primary objective of this study was to evaluate the performance of FIT during the CRC screening campaign in the Finistère department (France) from January 1, 2016 to December 31, 2017. Its secondary objectives were the evaluation of diagnostic circumstances and their impact on treatment and survival, and risk factors for interval cancer (IC).

Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening

Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study

Sensitivity = True positive / True positive + False negative = SD CRCs / SD CRCs + FIT IC

Age, sex, stages, localizations, comparison by Chi2 or Fisher's test for categorical data and Student's test for quantitative data. Multivariate analysis using logistic regression.

FIT value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),

Analysis of survival according to diagnostic circumstances

Analysis of treatment according to diagnostic circumstances

Registre des Tumeurs Digestives du Finistère

Centre Régional de Coordination des Dépistages des Cancers Bretagne (CRCDC Bretagne)

University Hospital, Brest

The standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home.

The standard letter is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; it also explains why test kits are being sent to disarm skepticism about the program.

In addition to the enhancements added by the letter with risks, the letter also includes a table comparing FIT kit and colonoscopy. Presenting different screening options allows recipients to make the choice that best suits them. In addition, presenting multiple options increases the chance that recipients get screened in one way or another.

In addition to the enhancements added by the letter with risk, the comparison table includes comparisons of the consequences of getting screened vs. waiting for symptoms to appear.

Recipients receive a letter promoting CRC screening.

Letter

The letter is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by showing the risks of colorectal cancer, while also showing that screening is an achievable means to address those risks.

Loss Frame and Fear Appeals

The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.

Transparency

The pros and cons for screening with FIT kits and colonoscopy are presented. By showing an additional option, the table frames the FIT kit as the default option (since they are included in the mailer). In this situation, inaction is no longer the default option. Changing the default option increases the chance that the FIT kit is used. In addition, another viable alternative is provided (colonoscopy), which still contributes to the goal of the project (getting screened).

Default Effect and Presentation of Alternatives

Comparisons of the mortality rates between screening with FIT kits, colonoscopy, and inaction (waiting for symptoms to appear) are displayed. Inaction is presented as a decoy, which has worse outcomes than either of the screening options. Due to this contrast, the inclusion of the decoy increases the appeal of the other screening options.

Enhanced Fear Appeals and Decoy Effect

Amir Goren, PhD

In this evaluation, 4 different versions of letters are being sent with mailers promoting colorectal cancer screening with an at-home test. The researchers hypothesize that the use of behavioral nudges in the message should lead to increased colorectal cancer screening (either with the at-home test or a colonoscopy).

Colorectal cancer (CRC) is the third most common cancer diagnosed in the US. Mailing fecal immunochemical (FIT) kits to at-risk patients is an effective way of increasing CRC testing uptake, as this test can be done at home and is less intrusive compared to colonoscopies. As part of an existing program, the health system mails FIT kits to eligible patients each year. Although this test needs to be conducted annually, not everyone who receives the test kit returns the kits for processing. In this study, the researchers aim to test different letters with the goal of encouraging the use of FIT kits or scheduling a colonoscopy.

As part of this study, the kits are mailed with everything the patient will need to conduct the test at home and mail a sample back to the hospital. It also includes an introductory letter informing the patient about the program and inviting them to use the kit. The researchers are comparing a standard version of the introductory letter against 3 versions that include different combinations of behavioral nudges, specifically framing effects (loss, default, decoy) and fear appeals.

Participants and providers are not aware of the different letter versions.

Evaluation of Letters Promoting Colorectal Cancer Testing

Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.

Binary variable indicating whether a valid FIT kit was returned for testing

Binary variable indicating whether a colonoscopy was ordered

Binary variable indicating whether a valid FIT kit was returned for testing (a longer time frame allows for late responses)

Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses)

Binary variable indicating whether the test was positive or negative (if FIT kit was returned)

Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)

Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)

Geisinger Clinic

Program Director, Behavioral Insights Team

Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.

Usual care plus automated mailing. Mailing 1 is a pamphlet about screening choices and number to call for colonoscopy. Mailing 2 is a FIT kit if not requesting colonoscopy. Mailing 3 is a Reminder letter.

Usual care, automated mailing plus, if screening is still not completed, phone assistance by a medical assistant (MA) who asks about patients screening intent, and provides brief assistance to complete this (e.g. sends another fecal test, assists with provider order for a colonoscopy).

Usual care, automated mailing, phone assistance by a medical assistant, plus navigation by a registered nurse (RN) if still not screened. Navigators are trained to use motivational interviewing techniques. They assess CRC and procedure risk, facilitate screening choice, address barriers, and provide follow-up until screening is completed.

Automated Mailing

If not screened after automated mailing, MA assists with screening.

Automated Mailing Plus Assisted

If not screened after automated mailing and assistance by MA, RN begins navigation.

Auto Plus Assisted Plus Navigation

Beverly B Green, MD, MPH

SOS is a four-arm randomized controlled study of ways to increase screening for colorectal cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is a very important problem because screening both prevents colorectal cancer and decreases colon cancer deaths.

We are studying 3 different levels of support to help people get screened and follow-up after positive screening tests. These involve comparing to usual care stepwise increasing in intensity approaches; an automated approach of mailing information and home screening tests, this plus phone assistance by a medical assistant, both of these plus phone counseling and care management. We will also compare nurse assisted follow-up after a positive screening test compared to usual care

By doing this study we hope to increase colon cancer screening rates, and also follow-up rates for positive screening tests.

Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up A. Specific Aims There is strong evidence that colorectal cancer screening (CRCS) decreases colorectal cancer (CRC) mortality and reduces colorectal cancer incidence. Despite the efficacy of screening, 40-60% of eligible adults are not screened at recommended intervals, and many have never had any type of CRCS. Screening failures occur not only from lack of screening but also from breakdowns in follow-up of positive tests, which obviates the benefits of screening. Strategies for improving the uptake of CRCS typically focus on either patients or health care providers, without describing the infrastructure changes, or systems of support (SOS), that are required to implement and sustain these changes.

We propose a two-part study using the Chronic Care Model to organize SOS. We will identify a cohort of Group Health patients aged 50 -73 years who have not had a colonoscopy (CS) in 10 years, a flexible sigmoidoscopy (FS) in 5 years, or a fecal occult blood test (FOBT) in 10 months.

Part One:

Subjects will be randomized to receive one of four interventions of stepwise increasing intensity of support.

1. Usual care (UC).
2. Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card).
3. Assisted (UC + automated + a medical assistant) to document screening intent and assists patients via the resources already supplied or sending requests to the patient's physician.
4. Care management (UC + automated + assisted + cancer screening nurse support) who counsels patient and assists with this screening plan (assessing procedural risk, and ordering tests).

Part Two: Patients with a positive FOBT or a positive FS (CS needed) will be randomized to one of two follow-up intervention arms: A. Usual care (which at Group Health includes a registry and physician alerts) or B. Care Management (UC + cancer screening nurse who manages care after a positive test). Our study hypotheses are that increasing levels of SOS will result in increasing CRCS rates, and care management by cancer screening nurses will increase follow-up rates after a positive test.

The primary specific aims are:

1. To compare the effectiveness of each intervention condition on increasing CRCS rates.
2. To compare the effectiveness of each intervention condition on follow-up after a positive screening test.

   The secondary aims are:
3. To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services
4. To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.

Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up

Systems of Support to Increase Colon Cancer Screening and Follow-up

Deidentified individual participant data and a data dictionary without investigator support will be made available upon request to Bev.B.Green@kp.org and approval.

The final dataset will include patient data from computerized medical records and telephone interviews with subjects. This includes demographic data (automated data and self-report), diagnoses, laboratory and procedure results and utilization data. Data will be made available as study manuscripts are published and will be de-identified prior to release for sharing.

To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2.

To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).

To compare adherence to CRC screening, among those randomized to receive continued interventions compared to stopped interventions: a) during year 3; b) over the 7 years of follow-up from re-randomization at year 3 through the end of year 9.

To compare by randomization arm the impact of SOS interventions on long-term outcomes (advanced adenomas and CRC by stage), costs, and cost-effectiveness.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combining Risk Factors and Faecal Immunochemical Testing in Colorectal Cancer Screening: a Randomized Controlled Trial	NCT04490551	Colorectal Canc... Colorectal Carc... Colorectal Neop... Colorectal Aden... Colorectal Aden...	Risk-based logi... FIT	55 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement	NCT01052922	Colorectal Canc...	3 sample g-SENS... 2 sample InSure 1 sample OC-Mic...	50 Years - 74 Years	Kaiser Permanente
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening	NCT05163236	Colorectal Neop... Colonoscopy Early Detection... Female Mass Screening Middle Aged Occult Blood	Positive fecal ... Negative fecal ... Fecal immunoche...	50 Years - 77 Years	University Hospital, Brest
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement	NCT01052922	Colorectal Canc...	3 sample g-SENS... 2 sample InSure 1 sample OC-Mic...	50 Years - 74 Years	Kaiser Permanente
Evaluation of Letters Promoting Colorectal Cancer Testing	NCT04548765	Cancer Colorect...	Letter Loss Frame and ... Transparency Default Effect ... Enhanced Fear A...	18 Years -	Geisinger Clinic
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement	NCT01052922	Colorectal Canc...	3 sample g-SENS... 2 sample InSure 1 sample OC-Mic...	50 Years - 74 Years	Kaiser Permanente
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening	NCT05163236	Colorectal Neop... Colonoscopy Early Detection... Female Mass Screening Middle Aged Occult Blood	Positive fecal ... Negative fecal ... Fecal immunoche...	50 Years - 77 Years	University Hospital, Brest
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up	NCT00697047	Colorectal Canc...	Automated Maili... Automated Maili... Auto Plus Assis...	50 Years - 73 Years	Kaiser Permanente

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