Telephone Services for Participation in Colorectal Cancer Screening (ColoPhone)

April 14, 2020 updated by: Marek Bugajski, Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

6300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazovian
      • Warsaw, Mazovian, Poland, 02-781
        • The Maria Sklodowska-Curie National Research Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Invitation letter and reminder letter to screening colonoscopy
EXPERIMENTAL: Call Center
Telephone recruitment by motivational conversation and colonoscopy appointment
Behavioral: Telephone recruitment to screening colonoscopy
Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation
EXPERIMENTAL: Combined
Non responders to invitation and reminder letter will be recruited by telephone conversation
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
26 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate to invitation to screening colonoscopy
Time Frame: 26 weeks after intervention
Contact with local PCSP center
26 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Ministry of Health, Poland
Screening up, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 20, 2020

Primary Completion (ANTICIPATED)

July 30, 2021

Study Completion (ANTICIPATED)

August 30, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (ACTUAL)

April 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ColoPhone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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