Back to resultsIncreasing Access to Breast Cancer Screening Among Immigrants
Primary Purpose
Cancer Screening
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Mother tongue and Norwegian
Sponsored by
About this trial
This is an interventional health services research trial for Cancer Screening focused on measuring cancer screening, breast cancer, non-native, immigrant, participation rate, invitation, information
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital, Cancer Registry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mother tongue and Norwegian
Norwegian
Arm Description
Written material related to screening sent to the invitee in two languages.
Written material related to screening sent to the invitee in Norwegian only.
Outcomes
Primary Outcome Measures
Screening attendance
Attendance in breast cancer screening programme (yes/no)
Secondary Outcome Measures
Full Information
NCT ID
NCT04672265
First Posted
November 16, 2020
Last Updated
March 24, 2023
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04672265
Brief Title
Increasing Access to Breast Cancer Screening Among Immigrants
Official Title
A Randomized Trial to Increase Access to Breast Cancer Screening by Invitation Language Among Immigrants in Norway
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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,
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Screening
Keywords
cancer screening, breast cancer, non-native, immigrant, participation rate, invitation, information
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
11355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mother tongue and Norwegian
Arm Type
Experimental
Arm Description
Written material related to screening sent to the invitee in two languages.
Arm Title
Norwegian
Arm Type
No Intervention
Arm Description
Written material related to screening sent to the invitee in Norwegian only.
Intervention Type
Other
Intervention Name(s)
Mother tongue and Norwegian
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screening attendance
Description
Attendance in breast cancer screening programme (yes/no)
Time Frame
0-6 months after sent screening invitation letter
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Berstad, PhD
Organizational Affiliation
Cancer Registry of Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Cancer Registry
City
Oslo
ZIP/Postal Code
0304
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Increasing Access to Breast Cancer Screening Among Immigrants
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