NCT04348058

Brief Summary

A multicentre randomized health services study within the population-based primary colonoscopy screening program (PCSP) in Poland. Individuals, aged 55-60 years, willl be randomized in a 1:1:1 ratio to arms: (1) Invitation by post, (2) Call Center or (2) Combined invitation methods. The primary outcome measure is rate of participation in screening colonoscopy. The sample size of 6 300 participants will detect 3 to 5 percentage point differences (depending on the arms comparison) in participation rate between groups with 80% power and significance level 0.05, using Ochran-Mantel-Haenszel test.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 10, 2020

Last Update Submit

April 14, 2020

Conditions

Participation Rate, Patient

Keywords

colorectal cancer screeningscreening colonoscopyscreening participationtelephone services

Outcome Measures

Primary Outcomes (1)

  • Participation rate to screening colonoscopy within PCSP per recruitment strategy

    The percentage of study participants who underwent screening colonoscopy relative to all PCSP participants to whom the invitation was sent in a given group during the observation period (intention-to-screen analysis)

    26 weeks after intervention

Secondary Outcomes (1)

  • Response rate to invitation to screening colonoscopy

    26 weeks after intervention

Study Arms (3)

Control group

NO INTERVENTION

Invitation letter and reminder letter to screening colonoscopy

Call Center

EXPERIMENTAL

Telephone recruitment by motivational conversation and colonoscopy appointment

Behavioral: Telephone recruitment to screening colonoscopy

Combined

EXPERIMENTAL

Non responders to invitation and reminder letter will be recruited by telephone conversation

Behavioral: Combined methods recruitment to screening colonoscopy

Interventions

Telephone recruitment to screening colonoscopyBEHAVIORAL

Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation

Call Center
Combined methods recruitment to screening colonoscopyBEHAVIORAL

Utilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation

Combined

Eligibility Criteria

Age55 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • population included to invitation within Polish population based Colorectal cancer Screening Program (PCSP)
  • 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)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Mazovian, 02-781, Poland

Location

Related Publications (6)

  • 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.

    PMID: 23485231BACKGROUND

  • 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.

    PMID: 23212726BACKGROUND

  • 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.

    PMID: 28600072BACKGROUND

  • 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.

    PMID: 26517847BACKGROUND

  • 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.

    PMID: 23663511BACKGROUND

  • 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.

    PMID: 31685010BACKGROUND

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Marek Bugajski, PhD

CONTACT

+48 22 546 23 28marek.bugajski@gmail.com

Małgorzata Pisera

CONTACT

+48 22 546 23 28mpisera@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD, Principal Investigator

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 15, 2020

Study Start

August 20, 2020

Primary Completion

July 30, 2021

Study Completion

August 30, 2021

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

PL(1)