Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Is the Information About a Doctor or Possibility of Choosing Doctor's Gender Associated With Attendance to Screening Colonoscopy: Randomized Study With Three Types of Invitations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182922
• Other study ID #: CO-I
• Status: Completed
• Phase: Phase 0
• First received: August 15, 2010
• Last updated: November 17, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• 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 purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate to screening colonoscopy.

Description:

Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is intended to investigate the effect of screening colonoscopy on colorectal cancer incidence and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden, Netherlands and Poland.

This study is designed to assess two factors potentially influencing patients attendance. These two factors are: identification of particular doctor performing examination and the possibility of choosing doctor's gender.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5100
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 64 Years

Eligibility

Inclusion Criteria:

• Individuals 55-64 years of age randomized to the screening arm of the NordICC trial in Poland

Exclusion Criteria:

• previous open colorectal surgery

• need for long term attention and nursing services (somatic or psychosocial reasons, mental retardation)

• ongoing cytotoxic treatment or radiotherapy for malignant disease

• severe chronic cardiac or pulmonary disease (NYHA III and IV)

• lifelong anticoagulant treatment

• coronary or cerebrovascular incident requiring hospitalization during the last three months

• residence abroad

• return of unopened letter of invitation and/or reminder, or message of death of the subject (not updated in Population Registry)

• failure to provide written informed consent

• screening colonoscopy within 10 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Screening

Intervention

Behavioral:
• Invitation letter
Invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.

Locations

Country	Name	City	State
Poland	The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of invitees attending screening colonoscopy in each invitation letter group		3 months from the primary assigned screening appointment date	No
Secondary	Percentage of forms with consent for examination, sent back after invitation letter but before reminding letter. Differences in attendance between men and women depending on type of the invitation.		3 weeks after the date of invitation letter	No