Back to resultsTime Schedules for Sending Invitations to Colonoscopy Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Six and three time schedule
Four and two time schedule
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring screening colonoscopy, attendance, response, colorectal cancer
Eligibility Criteria
Inclusion criteria:
Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.
Exclusion criteria:
- Resident abroad
- Return of unopened letter of invitation and/or reminder (address unknown)
- Message from neighbour/family/post office on death of screenee (not updated in Population Registry).
Exclusion criteria for colonoscopy:
- Individuals with previous colorectal surgery (resections, enterostomies)
- Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
- On-going cytotoxic treatment or radiotherapy for malignant disease
- Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
- Lifelong anticoagulant therapy with Warfarin
- A coronary event requiring hospitalization during the last 3 months
- A cerebrovascular event during the last 3 months
Sites / Locations
- Center of Oncology Institute and the Maria Sklodowska-Curie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Six and three time schedule
Four and two time schedule
Arm Description
Outcomes
Primary Outcome Measures
Participation rate
Percentage of attenders to screening colonoscopy.
Secondary Outcome Measures
Acceptance rate in SIX &THREE group
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Acceptance rate in FOUR&TWO group
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Response rate in SIX&THREE group
Percentage of invitees who responded (by phone or letter) before sending a reminder
Response rate in FOUR&TWO group
Percentage of invitees who responded (by phone or letter) before sending a reminder
Full Information
NCT ID
NCT01505972
First Posted
December 8, 2011
Last Updated
January 6, 2012
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
National Center for Research and Development, Poland
1. Study Identification
Unique Protocol Identification Number
NCT01505972
Brief Title
Time Schedules for Sending Invitations to Colonoscopy Screening
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
National Center for Research and Development, Poland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
screening colonoscopy, attendance, response, colorectal cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Six and three time schedule
Arm Type
Experimental
Arm Title
Four and two time schedule
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Six and three time schedule
Intervention Description
Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.
Intervention Type
Other
Intervention Name(s)
Four and two time schedule
Intervention Description
Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.
Primary Outcome Measure Information:
Title
Participation rate
Description
Percentage of attenders to screening colonoscopy.
Time Frame
6 months from the date of sending invitation letter
Secondary Outcome Measure Information:
Title
Acceptance rate in SIX &THREE group
Description
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Time Frame
3 weeks from the date of sending invitation letter
Title
Acceptance rate in FOUR&TWO group
Description
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Time Frame
2 weeks from the date of sending invitation letter, respectively
Title
Response rate in SIX&THREE group
Description
Percentage of invitees who responded (by phone or letter) before sending a reminder
Time Frame
3 weeks from the date of sending invitation letter
Title
Response rate in FOUR&TWO group
Description
Percentage of invitees who responded (by phone or letter) before sending a reminder
Time Frame
2 weeks from the date of sending invitation letter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.
Exclusion criteria:
Resident abroad
Return of unopened letter of invitation and/or reminder (address unknown)
Message from neighbour/family/post office on death of screenee (not updated in Population Registry).
Exclusion criteria for colonoscopy:
Individuals with previous colorectal surgery (resections, enterostomies)
Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
On-going cytotoxic treatment or radiotherapy for malignant disease
Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
Lifelong anticoagulant therapy with Warfarin
A coronary event requiring hospitalization during the last 3 months
A cerebrovascular event during the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regula Jaroslaw, MD, PhD
Organizational Affiliation
Center of Oncology UInstitute and the Maria Sklodowska-Curie
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kaminski F Michal, MD
Organizational Affiliation
Center of Oncology Institute and the Maria Sklodowska-Curie
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pisera Malgorzata, Msc
Organizational Affiliation
Center of Oncology Institute and the Maria Sklodowska-Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Oncology Institute and the Maria Sklodowska-Curie
City
Warsaw
State/Province
W.K.Roentgena
ZIP/Postal Code
02-781
Country
Poland
12. IPD Sharing Statement
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Time Schedules for Sending Invitations to Colonoscopy Screening
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