Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer

NCT02515344 | Completed DMC

• 1 other identifier: RC12_0497
• Study Type: interventional
• Target: 48,649
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective : to demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms. Enrollment: GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services). Patients will be eligible to the study depending on their eligibility to the Faecal Occult Blood Test for colorectal cancer screening : 1) they should be older than 50 and younger than 74; 2) they should not have a personal history of colorectal cancer (or history of adenoma bigger than 1 cm) nor a family history of colorectal cancer. Main outcomes measures : Patient participation to colorectal cancer screening, and number of cancers screened in (versus diagnosed outside) the screening procedure.

Conditions

Colorectal Cancer

Keywords

Patients; early detection of cancer; patient compliance

Outcome Measures

Primary Outcomes (1)

• Patient participation rate to colorectal cancer screening

  12 months after starting date of the study

Secondary Outcomes (1)

• Number of cancers screened in (versus diagnosed outside) the screening procedure.

  12 months after starting date of the study

Study Arms (3)

A: nominative list

EXPERIMENTAL

Providing a list of patients not compliant with CRC sreening General Practitioners allocated to the intervention group (A) will receive: * a nominative list of their patients who were not compliant to colorectal cancer screening. * a document providing general information about colorectal cancer screening

Other: Providing a list of patients not compliant with CRC sreening; Other: Providing general information about CRC sreening

B: general information

ACTIVE COMPARATOR

Providing general information about CRC screening General Practitioners allocated to group (B) will receive: \- a document providing general information about colorectal cancer screening (but will not receive the nominative list of patients non compliant to colorectal cancer screening)

Other: Providing general information about CRC sreening

C: usual practice

NO INTERVENTION

General Practitioners allocated to group (C) will not receive any information (as in usual practice)

Interventions

Providing a list of patients not compliant with CRC sreening OTHER

GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive this information.

A: nominative list

Providing general information about CRC sreening OTHER

A: nominative list; B: general information

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GPs allocated in the 3 groups of the study will be all GPs
• \) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average)
• \) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).

You may not qualify if:

• GPs who have less than 100 patients in their patient list

Sponsors & Collaborators

• Nantes University Hospital: lead
• Public Health Insurance: collaborator
• Université de Nantes: collaborator
• Organisms in charge of local cancer screening programs - France: collaborator
• Local Cancer Registry - France: collaborator

Related Publications (1)

• Rat C, Pogu C, Le Donne D, Latour C, Bianco G, Nanin F, Cowppli-Bony A, Gaultier A, Nguyen JM. Effect of Physician Notification Regarding Nonadherence to Colorectal Cancer Screening on Patient Participation in Fecal Immunochemical Test Cancer Screening: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):816-824. doi: 10.1001/jama.2017.11387.

  PMID: 28873160 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: August 4, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2016-09