Participation Rate, PatientColoPhoneNCT04348058
Telephone Services for Participation in Colorectal Cancer Screening
A study testing Telephone recruitment to screening colonoscopy and Combined methods recruitment to screening colonoscopy in people with Participation Rate, Patient, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 64 years
- Conditions the study is for
- Participation Rate, Patient
- What is being tested?
- Telephone recruitment to screening colonoscopy and Combined methods recruitment to screening colonoscopy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,300 participants
- Where
- 1 sitePoland
- Study dates
- 20 Aug 2020to 30 Aug 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 55 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- population included to invitation within Polish population based Colorectal cancer Screening Program (PCSP)
- 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)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Mazovian, 02-781
Marek Bugajski, PhD, +48 22 546 2328, marek.bugajski@gmail.com
Małgorzata Pisera, +48 22 546 23 28, mpisera@gmail.com
About this study
Official title: Telephone Services for Participation Improvement in Colorectal Cancer Screening: a Randomized Health Services Study
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.
Read the detailed description
This randomized health services study will be performed within national population-based screening program (PCSP) in Poland, including its population, infrastructure and database system.
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
- Participation Rate, Patient
- Being tested
- Telephone recruitment to screening colonoscopy, Combined methods recruitment to screening colonoscopy
- Keywords
- colorectal cancer screening, screening colonoscopy, screening participation, telephone services
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone recruitment to screening colonoscopyBehavioural
Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation
Combined methods recruitment to screening colonoscopyBehavioural
Utilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Invitation letter and reminder letter to screening colonoscopy |
| Call Center | Experimental | Telephone recruitment by motivational conversation and colonoscopy appointment Receives: Behavioral: Telephone recruitment to screening colonoscopy |
| Combined | Experimental | Non responders to invitation and reminder letter will be recruited by telephone conversation Receives: Behavioral: Combined methods recruitment to screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 26 weeks after intervention
Secondary outcomes (1)
Response rate to invitation to screening colonoscopy
Contact with local PCSP center
Measured: 26 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start20 Aug 2020 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Participation Rate, PatientStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective
- Masking
- None (open label)
- Enrolment
- 6,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland, Screening up, Poland
- Responsible party
- Principal investigator, Marek Bugajski, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348058
- Sponsor's protocol ID
- ColoPhone
- Acronym
- ColoPhone
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23485231European 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.
PubMed 23212726Rex 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.
PubMed 28600072Kaminski 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.
PubMed 26517847Camilloni 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.
PubMed 23663511Goodwin 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.
PubMed 31685010
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Services for Participation Improvement in Colorectal Cancer Screening: a Randomized Health Services Study
- ClinicalTrials.gov ID
- NCT04348058
- Acronym / sponsor ID
- ColoPhone / ColoPhone
- Conditions
- Participation Rate, Patient
- Keywords
- colorectal cancer screening, screening colonoscopy, screening participation, telephone services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland, Screening up, Poland
- Study start
- 20 Aug 2020 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 15 Apr 2020 (actual)
- 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.
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.
Detailed description
This randomized health services study will be performed within national population-based screening program (PCSP) in Poland, including its population, infrastructure and database system.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Invitation letter and reminder letter to screening colonoscopy |
| Call Center | Experimental | Behavioral: Telephone recruitment to screening colonoscopyTelephone recruitment by motivational conversation and colonoscopy appointment |
| Combined | Experimental | Behavioral: Combined methods recruitment to screening colonoscopyNon responders to invitation and reminder letter will be recruited by telephone conversation |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- population included to invitation within Polish population based Colorectal cancer Screening Program (PCSP)
- adress of residence near (not further than 40 kilometers) local PCSP centers (selected for the study based on population density)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Telephone recruitment to screening colonoscopyUtilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation | Behavioural | Call Center |
| Combined methods recruitment to screening colonoscopyUtilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation | Behavioural | Combined |
Primary outcome
Participation rate to screening colonoscopy within PCSP per recruitment strategy
Time frame: 26 weeks after intervention
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)
1 secondary outcome
Response rate to invitation to screening colonoscopy
Time frame: 26 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Background: PubMed 23485231Ferlay 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.
- Background: PubMed 23212726European 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.
- Background: PubMed 28600072Rex 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.
- Background: PubMed 26517847Kaminski 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.
- Background: PubMed 23663511Camilloni 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.
- Background: PubMed 31685010Goodwin 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone recruitment to screening colonoscopy and Combined methods recruitment to screening colonoscopy in people with Participation Rate, Patient, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Apr 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Bugajski, PhD (+48 22 546 23 28, marek.bugajski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate to screening colonoscopy within PCSP per recruitment strategy (time frame: 26 weeks 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 NCT04348058, which also lists 6 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 15 Apr 2020.