Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer (FAMKOL)

Martin-Luther-Universität Halle-Wittenberg

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Behavioral: Nurse-led counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT01903395

NKP332-032

Details and patient eligibility

About

BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk for colorectal cancer as well. Nevertheless, participation in the German national screening program stagnates at 2-3 percent per year even in this high-risk population.

AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy.

METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over Germany. Index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.

Enrollment: 313 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 18 and over
• being first-degree relatives of patients with diagnosed colorectal cancer
• able to understand German

Exclusion criteria

• Familial Adenomatous Polyposis
• utilization of diagnostic colonoscopy within the past 5 years
• being ever treated for colorectal cancer
• actual inflammatory bowl disease
• comorbidities associated with reduced further life expectancy (ECOG performance status >3

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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313 participants in 2 patient groups

Nurse-led counselling

Experimental group

Description:

First-degree relatives of patients undergoing active treatment for colorectal cancer are offered a nurse-led counselling by telephone regarding emotional and cognitive barriers to screening utilization.

Treatment:

Behavioral: Nurse-led counselling

Usual Care

No Intervention group

Description:

Usual print media, offered standardly by the recruiting centres.