Increasing Access to Breast Cancer Screening Among Immigrants

Sponsor

Oslo University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04672265

Collaborator

(none)

15,800

Enrollment

Arms

116.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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,

Condition or Disease	Intervention/Treatment	Phase
Cancer Screening	Other: Mother tongue and Norwegian	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomized to receive the invitation in the major official native language in the country the participant is born and Norwegian, or in Norwegian only, consecutively when it is their turn to be invited to screening.Participants are randomized to receive the invitation in the major official native language in the country the participant is born and Norwegian, or in Norwegian only, consecutively when it is their turn to be invited to screening.

Masking:

Single (Participant)

Masking Description:

The screening invitees randomized to the control group are not informed about this study. They receive "care as usual", the screening invitation letter in Norwegian language.

Primary Purpose:

Health Services Research

Official Title:

A Randomized Trial to Increase Access to Breast Cancer Screening by Invitation Language Among Immigrants in Norway

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mother tongue and Norwegian Written material related to screening sent to the invitee in two languages.	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.
No Intervention: Norwegian Written material related to screening sent to the invitee in Norwegian only.

Arm

Intervention/Treatment

Experimental: Mother tongue and Norwegian

Written material related to screening sent to the invitee in two languages.

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.

No Intervention: Norwegian

Written material related to screening sent to the invitee in Norwegian only.

Outcome Measures

Primary Outcome Measures

Screening attendance [0-6 months after sent screening invitation letter]
Attendance in breast cancer screening programme (yes/no)

Eligibility Criteria

Criteria

Ages Eligible for Study:

48 Years to 73 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Invited to screening program during the study recruitment period (January 2021-June

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