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

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.

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Screening
• Intervention / Treatment: Behavioral: Invitation letter

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 5100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-781
    • The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Doctor's Information Invitation; Standard invitation with additional leaflet containing information concerning particular doctor performing the examination, that is: his personal data (name, surname, academic title, workplace, picture) and data concerning experience and achievements of the center where he is employed.	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.
ACTIVE_COMPARATOR: Gender Preference Invitation; Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination	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.
ACTIVE_COMPARATOR: Standard Invitation; Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of invitees attending screening colonoscopy in each invitation letter group	3 months from the primary assigned screening appointment date

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Investigators: Study Director: Jaroslaw Regula, MD, PhD, Center of Oncology Institute; Principal Investigator: Krzysztof Skoczylas, MD, Center of Oncology Institute; Study Chair: Michal F Kaminski, MD, Center of Oncology Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: August 15, 2010
• First Submitted That Met QC Criteria: August 15, 2010
• First Posted (ESTIMATE): August 17, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Colorectal cancer; Screening; Invitation letter; Attendance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CO-I