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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Nurse-led counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-led counselling<br>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<br>* Nurse-led telephone counselling to double the utilization of preventive colonoscopy<br>|
| No Intervention: Usual Care<br>Usual print media, offered standardly by the recruiting centres. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| utilization of preventive colonoscopy |  | utilization within 30 days after enrolement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of advanced adenomas or carcinomas in situ |  | Rate within 6 month after enrolement | 
| post-operative complications associated with the colonoscopy |  | within 30 days after enrolement | 
| barriers to the use of preventive colonoscopy | 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. | within 30 day after enrolement, additional at 6 months after enrolement | 
| effectiveness and cost-effectiveness of nurse-led counselling |  | within 30 days after enrolement | 
| time delay between signed informed consent and utilization of colonoscopy |  | at utilization of the colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Colorectal Neoplasms/*drug therapy/*secondary, Health Services Accessibility, Humans, Supportive Care Needs, Psychooncology, Primary Health Care/*methods, Treatment Outcome, Socioeconomic Factors, Quality Assurance, Health Care, Aged, Aged, 80 and over