NCT04672265

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,

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,355

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Apr 2021Dec 2030

First Submitted

Initial submission to the registry

November 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

November 16, 2020

Last Update Submit

April 2, 2024

Conditions

Keywords

cancer screeningbreast cancernon-nativeimmigrantparticipation rateinvitationinformation

Outcome Measures

Primary Outcomes (1)

  • Screening attendance

    Attendance in breast cancer screening programme (yes/no)

    0-6 months after sent screening invitation letter

Study Arms (2)

Mother tongue and Norwegian

EXPERIMENTAL

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

Other: Mother tongue and Norwegian

Norwegian

NO INTERVENTION

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

Interventions

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.

Mother tongue and Norwegian

Eligibility Criteria

Age48 Years - 73 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not reached with the screening invitation letter because of wrong address or similar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Cancer Registry

Oslo, 0304, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Paula Berstad, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 17, 2020

Study Start

April 15, 2021

Primary Completion

August 31, 2022

Study Completion (Estimated)

December 31, 2030

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations