Colorectal Neoplasms
Conditions
Keywords
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, Adult, Aged, Aged, 80 and over
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.
Interventions
BEHAVIORALNurse-led counselling
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| utilization of preventive colonoscopy | utilization within 30 days after enrolement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | within 30 days after enrolement | — |
| time delay between signed informed consent and utilization of colonoscopy | at utilization of the colonoscopy | — |
Countries
Germany
Outcome results
None listed