NCT01182922

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,100

participants targeted

Target at P75+ for early_phase_1 colorectal-cancer

Timeline
Completed

Started Aug 2010

Shorter than P25 for early_phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 18, 2011

Status Verified

November 1, 2011

Enrollment Period

7 months

First QC Date

August 15, 2010

Last Update Submit

November 17, 2011

Conditions

Colorectal CancerScreening

Keywords

AttendanceColorectal cancerScreeningInvitation letter

Outcome Measures

Primary Outcomes (1)

  • Percentage of invitees attending screening colonoscopy in each invitation letter group

    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.

    3 weeks after the date of invitation letter

Study Arms (3)

Doctor's Information Invitation

ACTIVE COMPARATOR

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

Gender Preference Invitation

ACTIVE COMPARATOR

Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination

Behavioral: Invitation letter

Standard Invitation

ACTIVE COMPARATOR

Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.

Behavioral: Invitation letter

Interventions

Invitation letterBEHAVIORAL

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.

Doctor's Information InvitationGender Preference InvitationStandard Invitation

Eligibility Criteria

Age55 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, 02-781, Poland

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jaroslaw Regula, MD, PhD

    Center of Oncology Institute

    STUDY DIRECTOR

  • Krzysztof Skoczylas, MD

    Center of Oncology Institute

    PRINCIPAL INVESTIGATOR

  • Michal F Kaminski, MD

    Center of Oncology Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2010

First Posted

August 17, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

August 1, 2011

Last Updated

November 18, 2011

Record last verified: 2011-11

Locations

PL(1)