Increasing Access to Breast Cancer Screening Among Immigrants

April 2, 2024 updated by: Paula Berstad, Oslo University Hospital

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

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,

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0304
        • Oslo University Hospital, Cancer Registry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening attendance
Time Frame: 0-6 months after sent screening invitation letter
Attendance in breast cancer screening programme (yes/no)
0-6 months after sent screening invitation letter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Paula Berstad, PhD, Cancer Registry of Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/218
  • 213396 (Other Grant/Funding Number: The Norwegian Cancer Society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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