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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903395
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg

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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Nurse-led counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. utilization of preventive colonoscopy [ Time Frame: utilization within 30 days after enrolement ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903395


Locations
Show Show 33 study locations
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
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Principal Investigator: Alexander Bauer, PhD Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
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Responsible Party: Alexander Bauer, PhD, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01903395    
Other Study ID Numbers: NKP332-032
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg:
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
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases