Increasing Access to Breast Cancer Screening Among Immigrants

NCT ID: NCT04672265

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

11355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Mother tongue and Norwegian

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

Group Type EXPERIMENTAL

Mother tongue and Norwegian

Intervention Type OTHER

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.

Norwegian

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

48 Years

Maximum Eligible Age

73 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paula Berstad

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Berstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

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Oslo University Hospital, Cancer Registry

Oslo, , Norway

Site Status

Countries

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Norway

References

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Hofvind S, Iqbal N, Thy JE, Mangerud G, Bhargava S, Zackrisson S, Berstad P. Effect of invitation letter in language of origin on screening attendance: randomised controlled trial in BreastScreen Norway. BMJ. 2023 Sep 19;382:e075465. doi: 10.1136/bmj-2023-075465.

Reference Type DERIVED
PMID: 37726122 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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213396

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

19/218

Identifier Type: -

Identifier Source: org_study_id

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