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Completed

NCT Number: NCT01903395

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Landkreis Sigmaringen GmbH, Sigmaringen, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led counselling

Behavioral

Nurse-led telephone counselling to double the utilization of preventive colonoscopy

Primary outcomes

  1. utilization of preventive colonoscopy

    Time frame: utilization within 30 days after enrolement

Secondary outcomes

  1. Rate of advanced adenomas or carcinomas in situ

    Time frame: Rate within 6 month after enrolement

  2. post-operative complications associated with the colonoscopy

    Time frame: within 30 days after enrolement

  3. barriers to the use of preventive colonoscopy

    Time frame: within 30 day after enrolement, additional at 6 months after enrolement

    Barriers against preventive colonoscopy are very common among the healthy population. Such barriers can bei either of cognitive (e.g. being afraid of the potential diagnosis) or emotional nature (e.g. shame to be exposed naked to the examiners).

    Barriers are assessed by Barriers Questionnaire-II (BQ-II) during telephone counselling.

  4. effectiveness and cost-effectiveness of nurse-led counselling

    Time frame: within 30 days after enrolement

  5. time delay between signed informed consent and utilization of colonoscopy

    Time frame: at utilization of the colonoscopy

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy

Acronym: FAMKOL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 19, 2013
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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