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Completed

NCT Number: NCT01182922

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

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.

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Key information

Conditions

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

Age range

55 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,

Warsaw, 02-781, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invitation letter

Behavioral

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.

Primary outcomes

  1. Percentage of invitees attending screening colonoscopy in each invitation letter group

    Time frame: 3 months from the primary assigned screening appointment date

Secondary outcomes

  1. 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.

    Time frame: 3 weeks after the date of invitation letter

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2010
Registry last updated
Nov 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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