Telephone Services for Participation in Colorectal Cancer Screening
NCT ID: NCT04348058
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6300 participants
INTERVENTIONAL
2020-08-20
2021-08-30
Brief Summary
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Detailed Description
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Individuals aged 55-64 years old, included in PCSP willl be randomly assigned (in 1:1:1 ratio, stratified by gender, age, place of residence) to study arms and invited to screening colonoscopy to local PSCP centers.
Invitation process by post in Control group (1) and partially in Combined group (3) - will be performed by coordinating PCSP center (practice as usual).
Recruitment by telephone conversation in Call Center group (2) and partially in Combined group (3) - will be performed by Screening Up call center company. Colonoscopies will be performed in 6 selected PCSP centers.
The sample size of 2,100 participants per group (350 participants from each group in each center, assuming 5% drop out and access to telephone numbers of 30% participants in relevant arms; calculation is based on a 95% confidence interval +/- 5% error probability) was calculated to detect a difference in participation rate of 15% in control group (based on PCSP participation rate in 2019) vs. 18.7% in Call Center group vs 25% in Combined Invitation group (0.025 significance level with 80% power). The difference was calculated for the Cochran-Mantel-Haenszel test, assuming that the initial reporting in the control group will be as high as it was in 2019.
Differences in participation rate to screening colonoscopy between the study groups and the control group will be performed using Ochran-Mantel-Haenszel test (two-sided analysis), taking into account initial differences between rates at the significance level of 0.05.
The Principal Investigator of the study asked the Bioethical Committee with a request to release participants from signing of informed consent form to participation in the study, as they take part in a nationwide PSCP, financed by Ministry of Health in Poland - the study character is the Randomized Health Services Study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control group
Invitation letter and reminder letter to screening colonoscopy
No interventions assigned to this group
Call Center
Telephone recruitment by motivational conversation and colonoscopy appointment
Telephone recruitment to screening colonoscopy
Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation
Combined
Non responders to invitation and reminder letter will be recruited by telephone conversation
Combined methods recruitment to screening colonoscopy
Utilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation
Interventions
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Telephone recruitment to screening colonoscopy
Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation
Combined methods recruitment to screening colonoscopy
Utilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation
Eligibility Criteria
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Inclusion Criteria
* 55-64 of age
* no history of CRC
* no history of screening colonoscopy within PCSP
* adress of residence near (not further than 40 kilometers) local PCSP centers (selected for the study based on population density)
Exclusion Criteria
55 Years
64 Years
ALL
No
Sponsors
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Ministry of Health, Poland
OTHER_GOV
Screening up, Poland
UNKNOWN
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Marek Bugajski
PhD, MD, Principal Investigator
Locations
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The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Mazovian, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
European Colorectal Cancer Screening Guidelines Working Group; von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinas JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Madai S, Marinho J, Maucec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Tornberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.
Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients From the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Jul;153(1):307-323. doi: 10.1053/j.gastro.2017.05.013. Epub 2017 Jun 9.
Kaminski MF, Kraszewska E, Rupinski M, Laskowska M, Wieszczy P, Regula J. Design of the Polish Colonoscopy Screening Program: a randomized health services study. Endoscopy. 2015 Dec;47(12):1144-50. doi: 10.1055/s-0034-1392769. Epub 2015 Oct 30.
Camilloni L, Ferroni E, Cendales BJ, Pezzarossi A, Furnari G, Borgia P, Guasticchi G, Giorgi Rossi P; Methods to increase participation Working Group. Methods to increase participation in organised screening programs: a systematic review. BMC Public Health. 2013 May 13;13:464. doi: 10.1186/1471-2458-13-464.
Goodwin BC, Ireland MJ, March S, Myers L, Crawford-Williams F, Chambers SK, Aitken JF, Dunn J. Strategies for increasing participation in mail-out colorectal cancer screening programs: a systematic review and meta-analysis. Syst Rev. 2019 Nov 4;8(1):257. doi: 10.1186/s13643-019-1170-x.
Other Identifiers
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ColoPhone
Identifier Type: -
Identifier Source: org_study_id
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