Cancer ScreeningNCT04672265
Increasing Access to Breast Cancer Screening Among Immigrants
A study testing Mother tongue and Norwegian in people with Cancer Screening, run by Oslo University Hospital at 1 site in Norway.
Trial 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, Read more about this study
- Who is it for?
- Ages 48 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Screening
- What is being tested?
- Mother tongue and Norwegian
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,355 participants
- Where
- 1 siteNorway
- Study dates
- 15 Apr 2021to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not reached with the screening invitation letter because of wrong address or similar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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,
Read the 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.
- Conditions
- Cancer Screening
- Being tested
- Mother tongue and Norwegian
- Keywords
- cancer screening, breast cancer, non-native, immigrant, participation rate, invitation, information
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother tongue and NorwegianOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mother tongue and Norwegian | Experimental | Written material related to screening sent to the invitee in two languages. Receives: Other: Mother tongue and Norwegian |
| Norwegian | No intervention | Written material related to screening sent to the invitee in Norwegian only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening attendance
Attendance in breast cancer screening programme (yes/no)
Measured: 0-6 months after sent screening invitation letter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Apr 2021
- Primary completion31 Aug 2022
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 11,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Berstad, Oslo University Hospital
- Investigators
- Paula Berstad, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672265
- Sponsor's protocol ID
- 19/218
- Other IDs
- 213396
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37726122
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Increase Access to Breast Cancer Screening by Invitation Language Among Immigrants in Norway
- ClinicalTrials.gov ID
- NCT04672265
- Acronym / sponsor ID
- 19/218
- Conditions
- Cancer Screening
- Keywords
- cancer screening, breast cancer, non-native, immigrant, participation rate, invitation, information
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11,355 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mother tongue and Norwegian | Experimental | Other: Mother tongue and NorwegianWritten material related to screening sent to the invitee in two languages. |
| Norwegian | No intervention | –Written material related to screening sent to the invitee in Norwegian only. |
Who may qualify
- Ages
- 48 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Not reached with the screening invitation letter because of wrong address or similar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother tongue and NorwegianThe 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. | Other | Mother tongue and Norwegian |
Primary outcome
Screening attendance
Time frame: 0-6 months after sent screening invitation letter
Attendance in breast cancer screening programme (yes/no)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 37726122Hofvind 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Berstad, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother tongue and Norwegian in people with Cancer Screening, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening attendance (time frame: 0-6 months after sent screening invitation letter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.