Clinical trial NCT01505972: Time Schedules for Sending Invitations to Colonoscopy Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: screening colonoscopy
attendance
response
colorectal cancer
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
First posted: 2012-01-09
Enrollment: 1600
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Participation rate
timeFrame: 6 months from the date of sending invitation letter
Secondary outcomes:
measure: Acceptance rate in SIX &THREE group
timeFrame: 3 weeks from the date of sending invitation letter
measure: Acceptance rate in FOUR&TWO group
timeFrame: 2 weeks from the date of sending invitation letter, respectively
measure: Response rate in SIX&THREE group
timeFrame: 3 weeks from the date of sending invitation letter
measure: Response rate in FOUR&TWO group
timeFrame: 2 weeks from the date of sending invitation letter
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Center of Oncology Institute and the Maria Sklodowska-Curie
state: W.K.Roentgena
Study officials:
affiliation: Center of Oncology UInstitute and the Maria Sklodowska-Curie
name: Regula Jaroslaw, MD, PhD
role: STUDY_DIRECTOR
affiliation: Center of Oncology Institute and the Maria Sklodowska-Curie
name: Kaminski F Michal, MD
role: STUDY_CHAIR
affiliation: Center of Oncology Institute and the Maria Sklodowska-Curie
name: Pisera Malgorzata, Msc
role: PRINCIPAL_INVESTIGATOR
References: