A Trial of the Implementation of iFOBT in General Practice

NCT02308384 | Completed DMC

• 1 other identifier: Randomiseret iFOBT studie
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

Background Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC. Hypothesis It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer. Aim To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications. Materials and methods The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year. Perspectives This study will provide important knowledge on how to improve CRC diagnostics in general practice.

Conditions

Colorectal Cancer

Keywords

iFOBT; FIT; general practice; early diagnosis

Outcome Measures

Primary Outcomes (6)

• The rate of positive iFOBTs

  1 year

• The number of CRCs diagnosed after a positive iFOBT

  1 year

• The stage distribution of CRCs for patients with a positive iFOBT

  UICC stages I-IV

  1 year

• The positive predictive value for detecting colorectal cancer

  The risk of having CRC when the iFOBT is positive

  1 year

• The positive predictive value for detecting colorectal cancer in relation to cut-off value of iFOBT

  The risk of having CRC at different iFOBT values.

  1 year

• The positive predictive value for detecting colorectal cancer in relation to indications of using iFOBT

  The risk of having CRC when iFOBT is positive and specific symptoms. When requesting FIT, the GP register the patients' symptoms.

  1 year

Secondary Outcomes (6)

• The rate of general practices starting to use the iFOBT, stratified for participation in the CME.

  1 year

• The monthly rate of requested iFOBTs, stratified for participation in the CME.

  1 year

• The monthly rate of positive iFOBTs, stratified for participation in the CME.

  1 year

• Indications used for requesting iFOBT, stratified for participation in the CME.

  1 year

• The rate of referrals in the cancer patient pathway for colorectal cancer

  1 year

Study Arms (2)

Before intervention

NO INTERVENTION

GPs in this group have not yet received intervention.

After intervention

EXPERIMENTAL

GPs in this group have received the intervention.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

CME, Start-package and status mail

After intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• GPs in the Central Denmark Region
• Patients \>30 years eligible for iFOBT according to guideline

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Research Unit for General Practice

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• Juul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P. Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design. BMC Cancer. 2016 Jul 11;16:445. doi: 10.1186/s12885-016-2477-9.

  PMID: 27400657 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Interventions

Methods

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Peter Vedsted, Professor

  Research Unit of General Practice, Odense

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 27, 2017

Record last verified: 2015-11

Locations

DK (1)