Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000645954
Ethics application status
Approved
Date submitted
20/06/2011
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telephone Counseling and Attendance in a National breast cancer-screening Program - A Randomized Controlled Trial
Scientific title
A randomized trial of individual telephone counseling to increase attendance at nationwide population-based mammography screening in Germany in women who failed to have screening mammography within 6 weeks of a written invitation
Secondary ID [1] 262415 0
107992 (German CancerAid)
Universal Trial Number (UTN)
U1111-1122-3258
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 268109 0
Condition category
Condition code
Cancer 268253 268253 0 0
Breast
Public Health 268277 268277 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was conducted to investigate whether additional barrier-specific telephone counseling (telephone counseling +reminder letter) improves attendance in the German national mammography-screening program among nonresponders.
Eligible women living in a predefined region (based on ZIP codes) receive mailed invitation letters biennially for each screening round, starting with the 50th birthday. The invitation letters are sent out once a week, offering appointments two weeks in advance. After six weeks, non-responders are sent written reminders, again offering appointments two weeks in advance. These non-responders are the base population of the present study. For each of the non-responders, during the two weeks between the reminder was mailed and the appointment at the screening unit, the counselor obtained the mailing addresses and retrieved the telephone numbers for telephone counseling.
In barrier-specific TC, the counselor uses a standardized protocol, identifies the subject’s barriers to performing a health behavior, and then provides information to address and overcome the barriers. First, women are asked whether they wish information on the role of mammography-screening. If so, the counselor provides a brief description of mammography. Second, according to women’s current stage of readiness for mammography the counselor provides appropriate stage-specific information. During the most extensive part of telephone counseling the counselor tries to identify and overcome the woman’s individual barriers to screening and answers the woman’s questions. In her answers, the counselor is trained to refer to a set of preformulated facts, which are derived from guidelines or other validated sources and are implemented in the information system that the counselor uses for interview documentation. The components of the protocol include information on breast cancer risk, usefulness of a screening mammogram, inclusion and exclusion criteria for the German mammography screening program, details of the mammography examination, e.g. breast compression, possible pain, and radiation exposure, information on the reliability of mammography findings, consequences of mammography findings, the screening facility, the trip to the facility, and costs. All telephone calls and topics discussed are documented during the consultations using a dedicated database.
Intervention code [1] 266794 0
Early detection / Screening
Comparator / control treatment
no intervention (no additional telephone counseling) for nonresponders in the German national mammography-screening program (women receive mailed reminders alone)
Control group
Active

Outcomes
Primary outcome [1] 268979 0
report of mammography use provided by the screening unit
Timepoint [1] 268979 0
within three months after the reminder letter was sent
Secondary outcome [1] 276750 0
Satisfaction with telephone counseling: women in the intervention group are called four to eight weeks after counseling. They are asked how satisfied they were with the intervention and how it affected their decision concerning mammography-screening. Outcome is assessed using Likert scales.
Timepoint [1] 276750 0
eight weeks after intervention (after telephone counseling)

Eligibility
Key inclusion criteria
all women who are eligible for the national mammography screening program and who failed to have screening mammography within 6 weeks of a written invitation
Minimum age
50 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a woman who received a mammogram in the preceding 12 months; a woman diagnosed with breast cancer in the preceding five years

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer is performed by a study assistant who is only responsible for randomization and is not involved in the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5752
Accrual to date
Final
Recruitment outside Australia
Country [1] 3633 0
Germany
State/province [1] 3633 0
Mecklenburg-Vorpommern

Funding & Sponsors
Funding source category [1] 267265 0
Charities/Societies/Foundations
Name [1] 267265 0
Deutsche Krebshilfe (German Cancer Aid)
Country [1] 267265 0
Germany
Primary sponsor type
Individual
Name
Prof. Dr. N. Hosten
Address
Radiology Department
University-Hospital Greifswald
Ernst-Moritz-Arndt-University Greifswald
Ferdinand-Sauerbruchstr. 1
D-17475 Greifswald
Germany
Country
Germany
Secondary sponsor category [1] 266325 0
Individual
Name [1] 266325 0
Prof. Dr. W. Hoffmann
Address [1] 266325 0
Community Medicine
University-Hospital Greifswald
Ernst-Moritz-Arndt-University Greifswald
Ellernholzstr. 1/2
D-17487 Greifswald
Germany
Country [1] 266325 0
Germany
Secondary sponsor category [2] 266326 0
Individual
Name [2] 266326 0
Prof. Dr. U. Bick
Address [2] 266326 0
Radiology Department
Charite University Hospital
Humboldt-University Berlin
Chariteplatz 1
10098 Berlin
Germany
Country [2] 266326 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269261 0
Ethics Committee of the Ernst-Moritz-Arndt University Greifswald
Ethics committee address [1] 269261 0
Ethics committee country [1] 269261 0
Germany
Date submitted for ethics approval [1] 269261 0
Approval date [1] 269261 0
27/02/2007
Ethics approval number [1] 269261 0
BB 14/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32759 0
Address 32759 0
Country 32759 0
Phone 32759 0
Fax 32759 0
Email 32759 0
Contact person for public queries
Name 16006 0
Dr. Katrin Hegenscheid
Address 16006 0
Department of Radiology
University Hospital Greifswald
Ernst-Moritz-Arndt-University Greifswald
Ferdinand-Sauerbruchstr. 1
D-17475 Greifswald
Germany
Country 16006 0
Germany
Phone 16006 0
+49 3834 866946
Fax 16006 0
Email 16006 0
[email protected]
Contact person for scientific queries
Name 6934 0
Prof. Dr. Norbert Hosten
Address 6934 0
Department of Radiology
University Hospital Greifswald
Ernst-Moritz-Arndt-University Greifswald
Ferdinand-Sauerbruchstr. 1
D-17475 Greifswald
Germany
Country 6934 0
Germany
Phone 6934 0
+49 3834 866960
Fax 6934 0
Email 6934 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.