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

M

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

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.

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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