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Telephone Services for Participation in Colorectal Cancer Screening

Telephone Services for Participation Improvement in Colorectal Cancer Screening: a Randomized Health Services Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04348058
Acronym
ColoPhone
Enrollment
6300
Registered
2020-04-15
Start date
2020-08-20
Completion date
2021-08-30
Last updated
2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participation Rate, Patient

Keywords

colorectal cancer screening, screening colonoscopy, screening participation, telephone services

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.

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.

Interventions

BEHAVIORALTelephone recruitment to screening colonoscopy

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

BEHAVIORALCombined 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

Sponsors

Ministry of Health, Poland
CollaboratorOTHER_GOV
Screening up, Poland
CollaboratorUNKNOWN
Maria Sklodowska-Curie National Research Institute of Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

prospective

Eligibility

Sex/Gender
ALL
Age
55 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Participation rate to screening colonoscopy within PCSP per recruitment strategy26 weeks after interventionThe 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)

Secondary

MeasureTime frameDescription
Response rate to invitation to screening colonoscopy26 weeks after interventionContact with local PCSP center

Countries

Poland

Contacts

Primary ContactMarek Bugajski, PhD
marek.bugajski@gmail.com+48 22 546 23 28
Backup ContactMałgorzata Pisera
mpisera@gmail.com+48 22 546 23 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026