Colorectal CancerSOSNCT00697047
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up
A study testing Automated Mailing, Automated Mailing Plus Assisted and Auto Plus Assisted Plus Navigation in people with Colorectal Cancer, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 73 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Automated Mailing, Automated Mailing Plus Assisted and Auto Plus Assisted Plus Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,653 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not up to date on CRCS
- Continuously enrolled in Group Health Cooperative (GHC) for 24 months
- Expected to continue to be enrolled at GHC for 24 months.
Who cannot join
- Known high risk for CRC
- History of CRC
- History of inflammatory bowel disease
- Current anticoagulation therapy
- Organ failure
- Serious illness
Show all 9Show fewer
- Debilitating disease
- Dementia
- Nursing home resident.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Systems of Support to Increase Colon Cancer Screening and Follow-up
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.
Read the detailed description
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.
- Usual care (UC).
- Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card).
- 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.
- 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:
- To compare the effectiveness of each intervention condition on increasing CRCS rates.
- To compare the effectiveness of each intervention condition on follow-up after a positive screening test. The secondary aims are:
- To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services
- To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.
- Conditions
- Colorectal Cancer
- Being tested
- Automated Mailing, Automated Mailing Plus Assisted, Auto Plus Assisted Plus Navigation
- Keywords
- Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior, Colorectal Screening
- Medical subject headings
- Colorectal Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated MailingBehavioural
Usual Care plus Automated mailing
Automated Mailing Plus AssistedBehavioural
If not screened after automated mailing, MA assists with screening.
Auto Plus Assisted Plus NavigationBehavioural
If not screened after automated mailing and assistance by MA, RN begins navigation.
| Study group | Role | What they receive |
|---|---|---|
| 1- Usual Care | No intervention | Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening. |
| 2 - Automated Mailing | Experimental | 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. Receives: Behavioral: Automated Mailing |
| 3 - Automated Mailing Plus Assisted | Experimental | 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). Receives: Behavioral: Automated Mailing Plus Assisted |
| 4 - Auto Plus Assisted Plus Navigation | Experimental | 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. Receives: Behavioral: Auto Plus Assisted Plus Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term adherence to CRC screening
To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2.
Measured: From randomization to the end of 2 years
Long-term adherence to CRC screening
To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).
Measured: From randomization to the end of 9 years
Secondary outcomes (2)
Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3
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.
Measured: From year 3 to the end of 9 years
Impact of SOS interventions on outcomes and CRC-related costs
To compare by randomization arm the impact of SOS interventions on long-term outcomes (advanced adenomas and CRC by stage), costs, and cost-effectiveness.
Measured: From randomization to the end of 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJul 2008
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly B Green, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697047
- Sponsor's protocol ID
- 5R01CA121125
- Acronym
- SOS
- Status last verified
- Oct 2020
- First submitted
- 11 Jun 2008
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
Meenan RT, Anderson ML, Chubak J, Vernon SW, Fuller S, Wang CY, Green BB. An economic evaluation of colorectal cancer screening in primary care practice. Am J Prev Med. 2015 Jun;48(6):714-21. doi: 10.1016/j.amepre.2014.12.016.
PubMed 25998922Green BB, Anderson ML, Wang CY, Vernon SW, Chubak J, Meenan RT, Fuller S. Results of nurse navigator follow-up after positive colorectal cancer screening test: a randomized trial. J Am Board Fam Med. 2014 Nov-Dec;27(6):789-95. doi: 10.3122/jabfm.2014.06.140125.
PubMed 25381076Green BB, Wang CY, Horner K, Catz S, Meenan RT, Vernon SW, Carrell D, Chubak J, Ko C, Laing S, Bogart A. Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants. Contemp Clin Trials. 2010 Nov;31(6):589-603. doi: 10.1016/j.cct.2010.07.012. Epub 2010 Jul 30.
PubMed 20674774Green BB, Bogart A, Chubak J, Vernon SW, Morales LS, Meenan RT, Laing SS, Fuller S, Ko C, Wang CY. Nonparticipation in a population-based trial to increase colorectal cancer screening. Am J Prev Med. 2012 Apr;42(4):390-7. doi: 10.1016/j.amepre.2011.11.014.
PubMed 22424252Green BB, Wang CY, Anderson ML, Chubak J, Meenan RT, Vernon SW, Fuller S. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):301-11. doi: 10.7326/0003-4819-158-5-201303050-00002.
PubMed 23460053Wang CY, de Dieu Tapsoba J, Anderson ML, Vernon SW, Chubak J, Fuller S, Green BB. Time to screening in the systems of support to increase colorectal cancer screening trial. Cancer Epidemiol Biomarkers Prev. 2014 Aug;23(8):1683-8. doi: 10.1158/1055-9965.EPI-14-0270. Epub 2014 Jun 2.
PubMed 24891548Murphy CC, Vernon SW, Haddock NM, Anderson ML, Chubak J, Green BB. Longitudinal predictors of colorectal cancer screening among participants in a randomized controlled trial. Prev Med. 2014 Sep;66:123-30. doi: 10.1016/j.ypmed.2014.06.013. Epub 2014 Jun 15.
PubMed 24937648Green BB, Anderson ML, Chubak J, Fuller S, Meenan RT, Vernon SW. Impact of continued mailed fecal tests in the patient-centered medical home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up randomized trial. Cancer. 2016 Jan 15;122(2):312-21. doi: 10.1002/cncr.29734. Epub 2015 Oct 21.
PubMed 26488332Green BB, Anderson ML, Chubak J, Baldwin LM, Tuzzio L, Catz S, Cole A, Vernon SW. Colorectal Cancer Screening Rates Increased after Exposure to the Patient-Centered Medical Home (PCMH). J Am Board Fam Med. 2016 Mar-Apr;29(2):191-200. doi: 10.3122/jabfm.2016.02.150290.
PubMed 26957375Green BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Meenan RT, Vernon SW. A Centralized Program with Stepped Support Increases Adherence to Colorectal Cancer Screening Over 9 Years: a Randomized Trial. J Gen Intern Med. 2022 Apr;37(5):1073-1080. doi: 10.1007/s11606-021-06922-2. Epub 2021 May 28.
PubMed 34047921Green BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Kimbel KJ, Kullgren JT, Meenan RT, Vernon SW. Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e196570. doi: 10.1001/jamanetworkopen.2019.6570.
PubMed 31276178Green BB, BlueSpruce J, Tuzzio L, Vernon SW, Aubree Shay L, Catz SL. Reasons for never and intermittent completion of colorectal cancer screening after receiving multiple rounds of mailed fecal tests. BMC Public Health. 2017 May 30;17(1):531. doi: 10.1186/s12889-017-4458-6.
PubMed 28558663
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems of Support to Increase Colon Cancer Screening and Follow-up
- ClinicalTrials.gov ID
- NCT00697047
- Acronym / sponsor ID
- SOS / 5R01CA121125
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,653 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, The University of Texas Health Science Center, Houston
- Study start
- Jul 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Usual care (UC).
- Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card).
- 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.
- 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:
- To compare the effectiveness of each intervention condition on increasing CRCS rates.
- To compare the effectiveness of each intervention condition on follow-up after a positive screening test. The secondary aims are:
- To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services
- To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1- Usual Care | No intervention | –Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening. |
| 2 - Automated Mailing | Experimental | Behavioral: Automated MailingUsual 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. |
| 3 - Automated Mailing Plus Assisted | Experimental | Behavioral: Automated Mailing Plus AssistedUsual 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). |
| 4 - Auto Plus Assisted Plus Navigation | Experimental | Behavioral: Auto Plus Assisted Plus NavigationUsual 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. |
Who may qualify
- Ages
- 50 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not up to date on CRCS
- Continuously enrolled in Group Health Cooperative (GHC) for 24 months
- Expected to continue to be enrolled at GHC for 24 months.
Key exclusion criteria (9 listed)
- Known high risk for CRC
- History of CRC
- History of inflammatory bowel disease
- Current anticoagulation therapy
- Organ failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated MailingUsual Care plus Automated mailing | Behavioural | 2 - Automated Mailing |
| Automated Mailing Plus AssistedIf not screened after automated mailing, MA assists with screening. | Behavioural | 3 - Automated Mailing Plus Assisted |
| Auto Plus Assisted Plus NavigationIf not screened after automated mailing and assistance by MA, RN begins navigation. | Behavioural | 4 - Auto Plus Assisted Plus Navigation |
Primary outcome
Short-term adherence to CRC screening
Time frame: From randomization to the end of 2 years
To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2.
Long-term adherence to CRC screening
Time frame: From randomization to the end of 9 years
To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).
2 secondary outcomes
Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3
Time frame: From year 3 to the end of 9 years
Impact of SOS interventions on outcomes and CRC-related costs
Time frame: From randomization to the end of 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Results publication: PubMed 25998922Meenan RT, Anderson ML, Chubak J, Vernon SW, Fuller S, Wang CY, Green BB. An economic evaluation of colorectal cancer screening in primary care practice. Am J Prev Med. 2015 Jun;48(6):714-21. doi: 10.1016/j.amepre.2014.12.016.
- Results publication: PubMed 25381076Green BB, Anderson ML, Wang CY, Vernon SW, Chubak J, Meenan RT, Fuller S. Results of nurse navigator follow-up after positive colorectal cancer screening test: a randomized trial. J Am Board Fam Med. 2014 Nov-Dec;27(6):789-95. doi: 10.3122/jabfm.2014.06.140125.
- Results publication: PubMed 20674774Green BB, Wang CY, Horner K, Catz S, Meenan RT, Vernon SW, Carrell D, Chubak J, Ko C, Laing S, Bogart A. Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants. Contemp Clin Trials. 2010 Nov;31(6):589-603. doi: 10.1016/j.cct.2010.07.012. Epub 2010 Jul 30.
- Results publication: PubMed 22424252Green BB, Bogart A, Chubak J, Vernon SW, Morales LS, Meenan RT, Laing SS, Fuller S, Ko C, Wang CY. Nonparticipation in a population-based trial to increase colorectal cancer screening. Am J Prev Med. 2012 Apr;42(4):390-7. doi: 10.1016/j.amepre.2011.11.014.
- Results publication: PubMed 23460053Green BB, Wang CY, Anderson ML, Chubak J, Meenan RT, Vernon SW, Fuller S. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):301-11. doi: 10.7326/0003-4819-158-5-201303050-00002.
- Results publication: PubMed 24891548Wang CY, de Dieu Tapsoba J, Anderson ML, Vernon SW, Chubak J, Fuller S, Green BB. Time to screening in the systems of support to increase colorectal cancer screening trial. Cancer Epidemiol Biomarkers Prev. 2014 Aug;23(8):1683-8. doi: 10.1158/1055-9965.EPI-14-0270. Epub 2014 Jun 2.
- Results publication: PubMed 24937648Murphy CC, Vernon SW, Haddock NM, Anderson ML, Chubak J, Green BB. Longitudinal predictors of colorectal cancer screening among participants in a randomized controlled trial. Prev Med. 2014 Sep;66:123-30. doi: 10.1016/j.ypmed.2014.06.013. Epub 2014 Jun 15.
- Results publication: PubMed 26488332Green BB, Anderson ML, Chubak J, Fuller S, Meenan RT, Vernon SW. Impact of continued mailed fecal tests in the patient-centered medical home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up randomized trial. Cancer. 2016 Jan 15;122(2):312-21. doi: 10.1002/cncr.29734. Epub 2015 Oct 21.
- Results publication: PubMed 26957375Green BB, Anderson ML, Chubak J, Baldwin LM, Tuzzio L, Catz S, Cole A, Vernon SW. Colorectal Cancer Screening Rates Increased after Exposure to the Patient-Centered Medical Home (PCMH). J Am Board Fam Med. 2016 Mar-Apr;29(2):191-200. doi: 10.3122/jabfm.2016.02.150290.
- Derived from this study: PubMed 34047921Green BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Meenan RT, Vernon SW. A Centralized Program with Stepped Support Increases Adherence to Colorectal Cancer Screening Over 9 Years: a Randomized Trial. J Gen Intern Med. 2022 Apr;37(5):1073-1080. doi: 10.1007/s11606-021-06922-2. Epub 2021 May 28.
- Derived from this study: PubMed 31276178Green BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Kimbel KJ, Kullgren JT, Meenan RT, Vernon SW. Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e196570. doi: 10.1001/jamanetworkopen.2019.6570.
- Derived from this study: PubMed 28558663Green BB, BlueSpruce J, Tuzzio L, Vernon SW, Aubree Shay L, Catz SL. Reasons for never and intermittent completion of colorectal cancer screening after receiving multiple rounds of mailed fecal tests. BMC Public Health. 2017 May 30;17(1):531. doi: 10.1186/s12889-017-4458-6.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly B Green, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Mailing, Automated Mailing Plus Assisted and Auto Plus Assisted Plus Navigation in people with Colorectal Cancer, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term adherence to CRC screening (time frame: From randomization to the end of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00697047, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.