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Colorectal CancerNCT03510858

Randomized Controlled Trial on Colorectal Cancer Screening Among Quality Circles of Primary Care Physicians

A study testing Multilevel training intervention (intervention group) in people with Colorectal Cancer, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In Switzerland, colorectal cancer (CRC) is the third most common cause of death from cancer with 1600 persons dying from CRC each year. CRC screening can prevent most of these deaths. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Multilevel training intervention (intervention group)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSwitzerland
Study dates
14 Mar 2018to 30 Apr 2021
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physician-level: PCPs of different regions in Switzerland participating in Quality Circles comprising 4 to 19 PCPs and willing to participate in the study
  • Patient-level: Three Repeated measures over three years on 40 consecutive patients aged 50 to 75 years old seen in PCP offices over a 2 weeks to 2 months period. Patients will be included if there is a face-to-face consultation billed for at least 5 minutes at the practice.

Who cannot join

  • None except criteria which do not respect inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Institute of Primary Health Care (BIHAM), University of Bern

    Bern, 3012

Other trials in Switzerland

About this study

Official title: Colorectal Cancer Testing in Swiss Primary Care: A Pilot Pragmatic Cluster Randomized Controlled Trial in Quality Circles of Physicians

In Switzerland, colorectal cancer (CRC) is the third most common cause of death from cancer with 1600 persons dying from CRC each year. CRC screening can prevent most of these deaths. If screening begins at age 50, with either colonoscopy or faecal immunological test (FIT), the absolute risk of dying from CRC at age 80 can be cut in half. The choice between CRC screening methods can be seen as preference-sensitive condition. FIT can detect CRC at a similar rate as colonoscopy, but cannot detect as many polyps and advanced polyps as colonoscopies. Colonoscopy would seem the best choice for patients who want to reduce their risk of developing CRC or dying from CRC, but colonoscopy is an invasive procedure with rare but serious adverse effects. Patients who choose FIT do not need to prepare their bowels, or take a day off, but instead sample their own stool at home and mail the test to the laboratory. Offering the choice of test might also increase overall screening rates. Guidelines from the US Services Task Force (USPSTF) suggest shared decision making as a method for increasing adherence to screening and elicit patients' preferences for screening options.

Family physicians are recognized as the most trusted professional to discuss CRC screening in Switzerland. However, many primary care physicians (PCPs) appear to prefer colonoscopy over FIT, and the preferred method seems to vary widely between regions. Physician preferences and local medical culture likely determine these choices more than patient preference. It may be possible to reduce the number of PCPs who prescribe only one screening method by encouraging them to diagnose their patient's preferences for screening method. In Switzerland, training PCPs with educational support and decision aids increased the number who intend to prescribe both screening modalities in equal proportions (prescription of both colonoscopy and FIT in equal proportions).

Read more

To implement the intervention and determine how and if it changes PCP practice over time, the study will be conducted in quality circles (QCs) of PCPs. QCs are usually groups of 6 to 12 PCPs who meet regularly to reflect on their practice. QCs are a multifaceted, step-based intervention for quality improvement that has gained international traction because they can foster long-lasting behaviour change. In Switzerland, 80% of all PCPs attend QC regularly. Through QCs following the principles of Plan-Do-Check-Act (PDCA) quality improvement cycles, PCPs can find ways to lower structural barriers to screening, assess their screening practices, and give each other feedback.

The study hypothesizes that providing PCPs with evidence summaries on CRC screening, decision aids for patients, and sample FIT tests will increase the number of patients screened for CRC, better balance the selection of screening methods (colonoscopy vs. FIT), increase the proportion of patients with whom PCPs discuss CRC testing, and increase the number of patients who make decision for or against CRC screening.

The outcomes in PCPs of QCs allocated to the intervention group will be compared to those in the control group. The outcomes will be measured through anonymous structured patient data collected on 40 consecutive patients by PCPs and questionnaires filled by PCPs.

To ensure that relevant outcomes important for future implementation and dissemination works are collected, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be followed for structuring the data collection. The RE-AIM framework helps structure the collection of data on the characteristics of the participants invited who finally participate in the study (Reach), on the integration of the planned intervention in their work (Adoption), on the consistency of implementation of the planned intervention by study participants (Implementation), on the maintenance of the intervention effects over time (Maintenance), and finally, on the effectiveness of the intervention on the planned outcomes (Effectiveness). The RE-AIM criteria are useful for identifying the translatability and public health impact of this intervention, and for making clear to future stakeholders the internal and external validity of study results.

This study will test the benefits of a multilevel training program in participatory medicine designed to help PCPs in Switzerland to better diagnose patient preferences for screening and method of screening method (colonoscopy or FIT) through. If the program is successful it will increase the proportion of patients who can decide to undergo testing or not and with which method. This should increase in number of patients who are screened or intend to be screened for CRC, and thus reduce CRC deaths in the longer term.

Being tested
Multilevel training intervention (intervention group), Multilevel training intervention (control group with crossover)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multilevel training intervention (intervention group)Other

    QC meetings with PCPs in the intervention group to reflect on their CRC screening practices and implement changes in sequential Plan-Do-Check-Act (PDCA) quality improvement cycles. In the first meeting, they will be given evidence summaries on CRC screening, a decision support leaflet designed to help them discuss CRC screening with their patients and a patient decision aid in form of a brochure (Plan-Do). PCPs will receive sample FIT kits recommended for organized screening programs and will be encouraged to offer FIT tests if they have not done so before. In the second QC meeting, PCPs will be shown how to fill out the patient data collection form (Check). The third QC meeting will take place after data collection and analysis. Researchers will present their results to the QCs and PCPs will discuss subsequent steps to improve care (Act). The QC will then repeat one PDCA cycle. The control group will receive the same intervention one year later.

  • Multilevel training intervention (control group with crossover)Other

    The control group will undergo a crossover and receive the same intervention one year after the intervention group. QC meetings with PCPs in the intervention group to reflect on their CRC screening practices and implement changes in sequential Plan-Do-Check-Act (PDCA) quality improvement cycles. In the first meeting, they will be given evidence summaries on CRC screening, a decision support leaflet designed to help them discuss CRC screening with their patients and a patient decision aid in form of a brochure (Plan-Do). PCPs will receive sample FIT kits recommended for organized screening programs and will be encouraged to offer FIT tests if they have not done so before. In the second QC meeting, PCPs will be shown how to fill out the patient data collection form (Check). The third QC meeting will take place after data collection and analysis. Researchers will present their results to the QCs and PCPs will discuss subsequent steps to improve care (Act).

Study groups in NCT03510858
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Other: Multilevel training intervention (intervention group)
Control group with crossoverOtherParticipants in the control group will receive the intervention after 12 months, cross-over design
Receives: Other: Multilevel training intervention (control group with crossover)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients which have been tested for CRC

    PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years

    Measured: At 16 months after study begin

Secondary outcomes (5)
  1. Rate at which PCPs discuss CRC screening with eligible patients (patients not tested in recommended intervals, with no contra-indication for screening)

    PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years

    Measured: At 16 months after study begin

  2. Proportion of patients who were previously tested, plan to be tested or refuse tests

    PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years

    Measured: At 16 months after study begin

  3. Compare proportion of patients who were screened or plan to be screened with colonoscopy vs. FIT

    PCPs will systematically collect data from 40 consecutive patients, aged 50 to 75 years

    Measured: At 16 months after study begin

  4. Intentions to prescribe tests to screen for CRC

    A questionnaire filled by each participating PCP

    Measured: At 16 months after study begin

  5. Intention to prescribe colonoscopy vs. FIT within the next 6 months

    Through a questionnaire filled by each participating PCP

    Measured: At 16 months after study begin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start14 Mar 2018
  3. Primary completion30 Jan 2021
  4. Study completion30 Apr 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510858
Sponsor's protocol ID
RCTQC2018
Status last verified
Feb 2026
First submitted
15 Apr 2018
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Meester RG, Doubeni CA, Lansdorp-Vogelaar I, Goede SL, Levin TR, Quinn VP, Ballegooijen Mv, Corley DA, Zauber AG. Colorectal cancer deaths attributable to nonuse of screening in the United States. Ann Epidemiol. 2015 Mar;25(3):208-213.e1. doi: 10.1016/j.annepidem.2014.11.011. Epub 2014 Dec 5.

    PubMed 25721748
  • Gigerenzer G. Towards a paradigm shift in cancer screening: informed citizens instead of greater participation. BMJ. 2015 May 5;350:h2175. doi: 10.1136/bmj.h2175. No abstract available.

    PubMed 25943239
  • Schroy PC 3rd, Emmons KM, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvaganam SR, Coe AM, Chen CA, Chaisson CE, Pignone MP, Prout MN, Davidson PK, Heeren TC. Aid-assisted decision making and colorectal cancer screening: a randomized controlled trial. Am J Prev Med. 2012 Dec;43(6):573-83. doi: 10.1016/j.amepre.2012.08.018.

    PubMed 23159252
  • Salas D, Vanaclocha M, Ibanez J, Molina-Barcelo A, Hernandez V, Cubiella J, Zubizarreta R, Andreu M, Hernandez C, Perez-Riquelme F, Cruzado J, Carballo F, Bujanda L, Sarasqueta C, Portillo I, de la Vega-Prieto M, Morillas JD, Valentin V, Lanas A, Quintero E, Castells A. Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening. Cancer Causes Control. 2014 Aug;25(8):985-97. doi: 10.1007/s10552-014-0398-y. Epub 2014 May 24.

    PubMed 24859111
  • Inadomi JM, Vijan S, Janz NK, Fagerlin A, Thomas JP, Lin YV, Munoz R, Lau C, Somsouk M, El-Nachef N, Hayward RA. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012 Apr 9;172(7):575-82. doi: 10.1001/archinternmed.2012.332.

    PubMed 22493463
  • US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.

    PubMed 27304597
  • Bulliard JL, Ducros C, Levi F. [Organized screening for colorectal cancer: challenges and issues for a Swiss pilot study]. Rev Med Suisse. 2012 Jul 11;8(348):1464-7. French.

    PubMed 22934475
  • Klabunde CN, Lanier D, Nadel MR, McLeod C, Yuan G, Vernon SW. Colorectal cancer screening by primary care physicians: recommendations and practices, 2006-2007. Am J Prev Med. 2009 Jul;37(1):8-16. doi: 10.1016/j.amepre.2009.03.008. Epub 2009 May 13.

    PubMed 19442479
  • McQueen A, Bartholomew LK, Greisinger AJ, Medina GG, Hawley ST, Haidet P, Bettencourt JL, Shokar NK, Ling BS, Vernon SW. Behind closed doors: physician-patient discussions about colorectal cancer screening. J Gen Intern Med. 2009 Nov;24(11):1228-35. doi: 10.1007/s11606-009-1108-4. Epub 2009 Sep 18.

    PubMed 19763699
  • Meissner HI, Breen N, Klabunde CN, Vernon SW. Patterns of colorectal cancer screening uptake among men and women in the United States. Cancer Epidemiol Biomarkers Prev. 2006 Feb;15(2):389-94. doi: 10.1158/1055-9965.EPI-05-0678.

    PubMed 16492934
  • Cooper GS, Koroukian SM. Geographic variation among Medicare beneficiaries in the use of colorectal carcinoma screening procedures. Am J Gastroenterol. 2004 Aug;99(8):1544-50. doi: 10.1111/j.1572-0241.2004.30902.x.

    PubMed 15307875
  • Wennberg JE. Unwarranted variations in healthcare delivery: implications for academic medical centres. BMJ. 2002 Oct 26;325(7370):961-4. doi: 10.1136/bmj.325.7370.961. No abstract available.

    PubMed 12399352
  • Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: patients' preferences matter. BMJ. 2012 Nov 8;345:e6572. doi: 10.1136/bmj.e6572. No abstract available.

    PubMed 23137819
  • Selby K, Cornuz J, Gachoud D, Bulliard JL, Nichita C, Dorta G, Ducros C, Auer R. Training primary care physicians to offer their patients faecal occult blood testing and colonoscopy for colorectal cancer screening on an equal basis: a pilot intervention with before-after and parallel group surveys. BMJ Open. 2016 May 13;6(5):e011086. doi: 10.1136/bmjopen-2016-011086.

    PubMed 27178977
  • Beyer M, Gerlach FM, Flies U, Grol R, Krol Z, Munck A, Olesen F, O'Riordan M, Seuntjens L, Szecsenyi J. The development of quality circles/peer review groups as a method of quality improvement in Europe. Results of a survey in 26 European countries. Fam Pract. 2003 Aug;20(4):443-51. doi: 10.1093/fampra/cmg420.

    PubMed 12876119

Questions about this trial

What is this clinical trial studying?

A study testing Multilevel training intervention (intervention group) in people with Colorectal Cancer, run by University of Bern at 1 site in Switzerland.

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 2 inclusion and 1 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 27 Feb 2026. 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 Switzerland. 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?

Proportion of patients which have been tested for CRC (time frame: At 16 months after study begin). 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 NCT03510858, which also lists 20 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 27 Feb 2026.

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