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Time Schedules for Sending Invitations to Colonoscopy Screening
This study has been completed.
Sponsor:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
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
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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 Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
Resource links provided by NLM:
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 ]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 ]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
| 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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 June 23, 2017