Colorectal NeoplasmsFAMKOLNCT01903395
Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer
A study testing Nurse-led counselling in people with Colorectal Neoplasms, run by Martin-Luther-Universität Halle-Wittenberg at 33 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Nurse-led counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 33 sitesGermany
- Study dates
- Mar 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 and over
- being first-degree relatives of patients with diagnosed colorectal cancer
- able to understand German
Who cannot join
- 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 locations and contacts
33 sites in 1 country.
33 sites in 1 country
Germany33 sites
Klinikum Aschaffenburg
Aschaffenburg, Bavaria, 63739
Krankenhaus St. Marienwörth
Bad Kreuznach, Rhineland-Palatinate, 55543
Universitätsklinikum Knappschaftskrankenhaus Ruhr Universität Bochum
Bochum, Nordrhein-Wetsfalen, 44892
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, 38126
Allgemeines Krankenhaus Celle
Celle, Lower Saxony, 29223
Krankenhaus Köln-Holweide
Cologne, North Rhine-Westphalia, 51067
Klinik Evang. Krankenhaus Kalk
Cologne, North Rhine-Westphalia, 51103
Diakonissenkrankenhaus Dessau gemeinnützige GmbH
Dessau, Saxony-Anhalt, 06846
Johanniter-Krankenhaus Rheinhausen
Duisburg, North Rhine-Westphalia, 47228
Klinikum Barnim
Eberswalde, Brandenburg, 16225
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Sankt Elisabeth Hospital Gütersloh
Gütersloh, North Rhine-Westphalia, 33332
Klinikum Hanau
Hanau, Hesse, 63450
Westküstenklinikum Heide
Heide, Schleswig-Holstein, 25746
Universitätsklinikum Jena
Jena, Thuringia, 07747
Evangelisches Diakonissenkrankenhaus Leipzig gGmbH
Leipzig, Saxony, 04177
Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, 58515
Klinikum Ludwigsburg
Ludwigsburg, Baden-Würtemberg, 71640
Städtisches Klinikum Lüneburg
Lüneburg, Lower Saxony, 21339
Klinikum Magdeburg gemeinnützige GmbH
Magdeburg, Saxony-Anhalt, 39130
Diakoniekrankenhaus Mannheim
Mannheim, Baden-Würtemberg, 68163
Universitätsklinikum Gießen und Marburg
Marburg, Hesse, 35043
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, 49076
HELIOS Klinik Sangerhausen
Sangerhausen, Saxony-Anhalt, 06526
HELIOS Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19049
Kliniken Landkreis Sigmaringen GmbH
Sigmaringen, Baden-Wurttemberg, 72488
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, Rhineland-Palatinate, 67346
Klinikum Stuttgart Krankenhaus Bad Cannstatt
Stuttgart, Baden-Würtemberg, 70374
Universitätsklinikum Ulm
Ulm, Baden-Würtemberg, 89081
Gastroenterologische Schwerpunktpraxis Völklingen
Völklingen, Saarland, 66333
Evangelisches Krankenhaus Paul Gerhardt Stift
Wittenberg, Saxony-Anhalt, 06886
Praxis für Innere Medizin Dr. med. Regine Lange
Wittenberg, Saxony-Anhalt, 06886
Stiftung Juliusspital Würzburg
Würzburg, Bavaria, 97070
About this study
Official title: Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Nurse-led counselling
- 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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led counsellingBehavioural
Nurse-led telephone counselling to double the utilization of preventive colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led counselling | Experimental | 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. Receives: Behavioral: Nurse-led counselling |
| Usual Care | No intervention | Usual print media, offered standardly by the recruiting centres. |
What is being measured
The primary outcome is the main question the study is designed to answer.
utilization of preventive colonoscopy
Measured: utilization within 30 days after enrolement
Secondary outcomes (5)
Rate of advanced adenomas or carcinomas in situ
Measured: Rate within 6 month after enrolement
post-operative complications associated with the colonoscopy
Measured: 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.
Measured: within 30 day after enrolement, additional at 6 months after enrolement
effectiveness and cost-effectiveness of nurse-led counselling
Measured: within 30 days after enrolement
time delay between signed informed consent and utilization of colonoscopy
Measured: at utilization of the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Alexander Bauer, PhD, Principal investigator, Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903395
- Sponsor's protocol ID
- NKP332-032
- Acronym
- FAMKOL
- Status last verified
- Oct 2016
- First submitted
- 11 Jul 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
- ClinicalTrials.gov ID
- NCT01903395
- Acronym / sponsor ID
- FAMKOL / NKP332-032
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms/*drug therapy/*secondary, Health Services Accessibility, Humans, Supportive Care Needs, Psychooncology, Primary Health Care/*methods, Treatment Outcome, Socioeconomic Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led counselling | Experimental | Behavioral: Nurse-led counsellingFirst-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. |
| Usual Care | No intervention | –Usual print media, offered standardly by the recruiting centres. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 and over
- being first-degree relatives of patients with diagnosed colorectal cancer
- able to understand German
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led counsellingNurse-led telephone counselling to double the utilization of preventive colonoscopy | Behavioural | Nurse-led counselling |
Primary outcome
utilization of preventive colonoscopy
Time frame: utilization within 30 days after enrolement
5 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bauer, PhD principal investigator
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led counselling in people with Colorectal Neoplasms, run by Martin-Luther-Universität Halle-Wittenberg at 33 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
utilization of preventive colonoscopy (time frame: utilization within 30 days after enrolement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.