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Colorectal CancerNCT03552744

Colorectal Cancer Screening Among Primary Care Physicians of the Swiss Sentinel Surveillance Network

A study testing Mailed training intervention 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

Colorectal cancer (CRC) is the third leading cause of cancer mortality in Switzerland, and kills 1600 people annually. Most deaths could be prevented by screening, but the 2012 Swiss national health survey found that only 40% of 50-75-year-olds had been tested within recommended intervals (26% with colonoscopy in the… 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?
Mailed training intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteSwitzerland
Study dates
26 Apr 2018to 1 Apr 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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physician-level: PCPs participating in the Swiss Sentinel Surveillance Network (Sentinella) willing to participate in the study
  • Patient-level: Each PCP will collect data 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 Cluster Randomized Controlled Trial Among Primary Care Physicians of the Swiss Sentinel Surveillance Network

Colorectal cancer (CRC) is the third leading cause of cancer mortality in Switzerland, and kills 1600 people annually. Most deaths could be prevented by screening, but the 2012 Swiss national health survey found that only 40% of 50-75-year-olds had been tested within recommended intervals (26% with colonoscopy in the last 10 year, 7% with fecal occult blood test [FOBT] in the last 2 years, and 7% with both). If screening starts at age 50, in the average risk population absolute risk of dying from CRC at age 80 can be cut from 2% to 1%, reducing relative risk by 50%. Since 2013, Switzerland has reimbursed screening by colonoscopy every 10 years or FOBT every 2 years for adults 50-69 years old. Conforming to current recommendations, the Federal Office of Public Health (FOPH) officially recognizes both screening modalities.

When patients are offered a choice of screening test (colonoscopy vs. FOBT), they are as likely to opt for one as the other. Patient preferences are unlikely to vary much between PCP practices, so distribution of colonoscopy and FOBT within each practice should also be roughly equal. Family physicians are recognized as the most trusted professional to discuss CRC screening in Switzerland. However, many primary care physicians (PCPs) prefer prescribing colonoscopy over FOBT, but physician preference for method seems to vary widely between regions. If physician preferences and local medical culture currently influence choice of method more strongly than patient preferences, encouraging PCPs to diagnose patient preferences for screening method may reduce the number of PCPs who prescribe only one method. An earlier study in Switzerland showed that training PCPs and giving them educational support and decision aids raised the number who intend to prescribe colonoscopy and FOBT in equal proportions. A randomized controlled trial in the US showed that when patients were offered both FOBT and colonoscopy rather than only colonoscopy alone, more patients were screened for CRC. Offering choice of method may thus increase overall screening rates.

Read more

The Swiss Sentinel Surveillance Network (Sentinella) is a cooperative surveillance project including the Federal Office of Public Health (FOPH), PCPs representatives and the five Swiss institutes of family medicine. A sample of 150 to 250 general practitioners, internists and pediatricians in private practices from all regions of Switzerland report weekly morbidity data to the network using irreversibly anonymized patient data collected during consultations. In 2017, 91 out of 129 eligible PCPs of the Sentinella network participated in a cross-sectional data collection on CRC screening. The Sentinella network appears ideally suited to perform an intervention in order to modify screening practices and measure outcomes using the same collection form as in 2017.

This study will test the benefits of a prepackaged training program in participatory medicine sent by post to PCPs in Switzerland. The package is designed to improve their diagnoses of patient preferences for screening and screening method (colonoscopy or FOBT). The study begins with the hypothesis that giving PCPs evidence summaries on CRC screening, decision aids for patients, and performance feedback on the 2017 data collection will increase the number of PCPs whose patients include at least one screened with FOBT, and who will prescribe at least one FOBT/FIT (Fecal Immunochemical Test) instead of prescribing only colonoscopy. This might reduce variation in care between PCP practices by increasing variation in methods of screening prescribed within each PCP practices. Analyses from the 2017 data collection suggest that fewer patients refused CRC testing in practices that offered both methods than in practices that offered only colonoscopy. This intervention might increase screening rates overall, while respecting patient's autonomy to refuse the test and to be prescribed the test they prefer.

The study will compare outcomes among PCPs allocated to the intervention group to those in the control group, and will be measured by collecting anonymous structured patient data on 40 consecutive patients by PCPs and questionnaires filled by PCPs.

The study is designed to fit within the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework for structuring data collection. RE-AIM ensures that a study's outcomes for future implementation and dissemination works are collected. The RE-AIM criteria will be used to identify the translatability and public health impact of this intervention, and for making clear to future stakeholders the internal and external validity of study results.

Being tested
Mailed training intervention
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Mailed training interventionOther

    PCPs from the intervention group will be mailed an intervention package that includes:

    1. 2-page structured evidence summary on CRC screening and information about Colonoscopy \& FIT ("Decision box")
    2. patient decision aid (20-page booklet) on CRC screening for distribution to patients (Decision Aid)
    3. video example for the PCP, which illustrates a participatory approach to discussing CRC screening with a patient
    4. 4-page abridged version of the booklet to support PCPs when they discuss CRC screening with patients during a clinical visit ("Decision Board")
    5. individualized 1-page summary of PCP screening practices comparing their individual prescription patterns to group patterns, based on the data collected in 2017 ("Performance card")
    6. 2-page document that encourages PCPs still using the inferior guaiac-based FOBT to switch to FIT and includes list of laboratories from which they can order FIT
    7. sample FIT for PCPs who may not be familiar with its contents and use
Study groups in NCT03552744
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Other: Mailed training intervention
Control groupNo interventionNot described

What is being measured

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

  1. Number of PCPs who have at least one patient ever tested with FOBT, or who prescribe at least one FOBT to eligible patients (patients not already tested within recommended intervals, with no contra-indication for screening).

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

    Measured: At 3 months after intervention

Secondary outcomes (4)
  1. Number of PCPs whose proportion of patients previously tested or planning to be tested with FOBT/colonoscopy is at least 40% (the PCP must have discussed screening with these patients, who have no symptoms or risk factors for CRC

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

    Measured: At 3 months after intervention

  2. Number of PCPs who discussed CRC with >50% of their eligible patients (patients not tested within recommended intervals, with no contra-indications for CRC screening)

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

    Measured: At 3 months after intervention

  3. Change in PCPs' future intentions to prescribe CRC screening tests

    A questionnaire completed by participating PCPs

    Measured: At 3 months after intervention

  4. Change in PCPs' future intentions to prescribe colonoscopy vs. FOBT over the next 6 months

    A questionnaire completed by participating PCPs

    Measured: At 3 months after intervention

Timeline

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

  1. First posted12 Jun 2018
  2. Study start26 Apr 2018
  3. Primary completion1 Apr 2019
  4. Study completion1 Apr 2019

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552744
Sponsor's protocol ID
RCTSentinella2018
Status last verified
Jun 2019
First submitted
25 May 2018
Last updated
19 Jun 2019
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
  • Fedewa SA, Cullati S, Bouchardy C, Welle I, Burton-Jeangros C, Manor O, Courvoisier DS, Guessous I. Colorectal Cancer Screening in Switzerland: Cross-Sectional Trends (2007-2012) in Socioeconomic Disparities. PLoS One. 2015 Jul 6;10(7):e0131205. doi: 10.1371/journal.pone.0131205. eCollection 2015.

    PubMed 26147803
  • 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
  • European guidelines for quality assurance in colorectal cancer screening and diagnosis. Luxembourg: Publications Office of the European Union, 2012

  • publique, O.f.d.l.s., Dépistage du cancer du côlon. 2013: p. p. 455

  • 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
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Mailed training intervention 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 19 Jun 2019. 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?

Number of PCPs who have at least one patient ever tested with FOBT, or who prescribe at least one FOBT to eligible patients (patients not already tested within recommended intervals, with no contra-indication for screening). (time frame: At 3 months after intervention). 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 NCT03552744, which also lists 17 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 19 Jun 2019.

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