NCT01279278

Brief Summary

The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,700

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 19, 2011

Status Verified

September 1, 2010

Enrollment Period

7 months

First QC Date

January 18, 2011

Last Update Submit

January 18, 2011

Conditions

Keywords

Colorectal CancerScreeningGeneral PractitionerFecal Occult Blood Tests

Outcome Measures

Primary Outcomes (1)

  • Completion of Fecal Occult Blod Test

    Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions).

    7 months

Secondary Outcomes (3)

  • Measure the impact of co-signing on deadline for completion of the test after the mailing.

    7 months

  • Compare the proportion of uninterpretable tests.

    7 months

  • Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications.

    7 months

Study Arms (2)

Control

NO INTERVENTION
Other: Classical Letter

Co-signed Letter

EXPERIMENTAL
Other: Co-signed letter

Interventions

Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.

Co-signed Letter

Patients receive classical letter signed by the coordinator doctor of ADECA

Control

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged : 50 to 74 years.
  • Not having ever been invited to participate in colorectal screening.

You may not qualify if:

  • Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Paris Descartes

Paris, Île-de-France Region, 75014, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 19, 2011

Record last verified: 2010-09

Locations