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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04672265
Other study ID # 19/218
Secondary ID 213396
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 15, 2021
Est. completion date December 31, 2030

Study information

Verified date April 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to test whether inviting immigrants to breast cancer screening with a letter in their mother tongue in addition to the standard letter in Norwegian changes screening uptake in these immigrant groups, compared with a comparable group who receive the invitation in Norwegian only,


Description:

Women in selected immigrant groups according to birth country will be invited to screening and randomized in a 1:1 ratio to receive the screening invitation and information material 1) in the major official native language in the country the invitee is born in addition to Norwegian (intervention group), or 2) only Norwegian (control). The 13 selected countries of origin are Poland, the Philippines, Pakistan, Somalia and Arabic speaking countries (Iraq, Syria, Morocco, Lebanon, Algeria, Egypt, Palestine, Sudan and Tunisia). The five intervention languages will thus be Polish, English, Urdu, Somali and Arabic.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 11355
Est. completion date December 31, 2030
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 48 Years to 73 Years
Eligibility Inclusion Criteria: - Invited to screening program during the study recruitment period (January 2021-June 2022) - The registered country of birth of the invitee is one of the following; Poland, Pakistan, Philippines, Somalia, Iraq, Syria, Morocco, Lebanon, Algeria, Egypt, Palestine, Sudan and Tunisia Exclusion Criteria: - Not reached with the screening invitation letter because of wrong address or similar

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mother tongue and Norwegian
The screening invitation letter, the information leaflet, the reminder letter and the result letter will be sent in two languages; an official language in the country where the invitee is born, and Norwegian.

Locations

Country Name City State
Norway Oslo University Hospital, Cancer Registry Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Screening attendance Attendance in breast cancer screening programme (yes/no) 0-6 months after sent screening invitation letter
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