Time Schedules for Sending Invitations to Colonoscopy Screening

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505972
• Other study ID #: NR13002404_1
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: January 6, 2012
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Six and three time schedule
Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.
• Four and two time schedule
Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.

Locations

Country	Name	City	State
Poland	Center of Oncology Institute and the Maria Sklodowska-Curie	Warsaw	W.K.Roentgena

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	The National Centre for Research and Development, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rate	Percentage of attenders to screening colonoscopy.	6 months from the date of sending invitation letter	No
Secondary	Acceptance rate in SIX &THREE group	Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder	3 weeks from the date of sending invitation letter	No
Secondary	Acceptance rate in FOUR&TWO group	Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder	2 weeks from the date of sending invitation letter, respectively	No
Secondary	Response rate in SIX&THREE group	Percentage of invitees who responded (by phone or letter) before sending a reminder	3 weeks from the date of sending invitation letter	No
Secondary	Response rate in FOUR&TWO group	Percentage of invitees who responded (by phone or letter) before sending a reminder	2 weeks from the date of sending invitation letter	No