Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer (FAMKOL)
|ClinicalTrials.gov Identifier: NCT01903395|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : October 25, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Behavioral: Nurse-led counselling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||313 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Nurse-led counselling
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.
Behavioral: Nurse-led counselling
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
No Intervention: Usual Care
Usual print media, offered standardly by the recruiting centres.
- utilization of preventive colonoscopy [ Time Frame: utilization within 30 days after enrolement ]
- Rate of advanced adenomas or carcinomas in situ [ Time Frame: Rate within 6 month after enrolement ]
- post-operative complications associated with the colonoscopy [ Time Frame: within 30 days after enrolement ]
- 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.
- effectiveness and cost-effectiveness of nurse-led counselling [ Time Frame: within 30 days after enrolement ]
- time delay between signed informed consent and utilization of colonoscopy [ Time Frame: at utilization of the colonoscopy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903395
|Principal Investigator:||Alexander Bauer, PhD||Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science|