Time Schedules for Sending Invitations to Colonoscopy Screening
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ClinicalTrials.gov Identifier: NCT01505972 |
Recruitment Status
:
Completed
First Posted
: January 9, 2012
Last Update Posted
: January 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Other: Six and three time schedule Other: Four and two time schedule | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
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.
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- Participation rate [ Time Frame: 6 months from the date of sending invitation letter ]Percentage of attenders to screening colonoscopy.
- Acceptance rate in SIX &THREE group [ Time Frame: 3 weeks from the date of sending invitation letter ]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 ]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 ]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 ]Percentage of invitees who responded (by phone or letter) before sending a reminder

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Ages Eligible for Study: | 55 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505972
Poland | |
Center of Oncology Institute and the Maria Sklodowska-Curie | |
Warsaw, W.K.Roentgena, Poland, 02-781 |
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 |
Responsible Party: | Maria Sklodowska-Curie Institute - Oncology Center |
ClinicalTrials.gov Identifier: | NCT01505972 History of Changes |
Other Study ID Numbers: |
NR13002404_1 |
First Posted: | January 9, 2012 Key Record Dates |
Last Update Posted: | January 10, 2012 |
Last Verified: | January 2012 |
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
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 |