Time Schedules for Sending Invitations to Colonoscopy Screening

This study has been completed.

Sponsor:

Collaborator:

The National Centre for Research and Development, Poland

Information provided by (Responsible Party):

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

ClinicalTrials.gov Identifier:

NCT01505972

First received: December 8, 2011

Last updated: January 6, 2012

Last verified: January 2012

History of Changes

Purpose

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.

Condition	Intervention
Colorectal Cancer	Other: Six and three time schedule Other: Four and two time schedule


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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:

Participation rate [ Time Frame: 6 months from the date of sending invitation letter ] [ Designated as safety issue: No ]
Percentage of attenders to screening colonoscopy.

Secondary Outcome Measures:

Acceptance rate in SIX &THREE group [ Time Frame: 3 weeks from the date of sending invitation letter ] [ Designated as safety issue: No ]
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Acceptance rate in FOUR&TWO group [ Time Frame: 2 weeks from the date of sending invitation letter, respectively ] [ Designated as safety issue: No ]
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Response rate in SIX&THREE group [ Time Frame: 3 weeks from the date of sending invitation letter ] [ Designated as safety issue: No ]
Percentage of invitees who responded (by phone or letter) before sending a reminder
Response rate in FOUR&TWO group [ Time Frame: 2 weeks from the date of sending invitation letter ] [ Designated as safety issue: No ]
Percentage of invitees who responded (by phone or letter) before sending a reminder


Enrollment:	1600
Study Start Date:	March 2011
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	55 Years to 64 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505972

Locations


Poland
Center of Oncology Institute and the Maria Sklodowska-Curie
Warsaw, W.K.Roentgena, Poland, 02-781

Sponsors and Collaborators

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

The National Centre for Research and Development, Poland

Investigators


Study Director:	Regula Jaroslaw, MD, PhD	Center of Oncology UInstitute and the Maria Sklodowska-Curie
Study Chair:	Kaminski F Michal, MD	Center of Oncology Institute and the Maria Sklodowska-Curie
Principal Investigator:	Pisera Malgorzata, Msc	Center of Oncology Institute and the Maria Sklodowska-Curie

More Information


Responsible Party:	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:	NCT01505972 History of Changes
Other Study ID Numbers:	NR13002404_1
Study First Received:	December 8, 2011
Last Updated:	January 6, 2012
Health Authority:	Poland: Ethics Committee

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:


screening colonoscopy attendance response colorectal cancer

Additional relevant MeSH terms:


Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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