Participation Rate, Patient Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT05244265 -
Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults
|
N/A |