Cancer ColorectalNCT06324409
ImmigrantScreen Telephone Reminder Trial in Colorectal Cancer Screening
A study testing Reminder telephone call in people with Cancer Colorectal, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The goal of this randomized trial is to test the effect of a reminder telephone call in the official native language in the country where the invitee is born, in addition to the reminder letter in Norwegian on participation in the National Colorectal Cancer Screening Program in Pakistani and Somalian immigrants… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Reminder telephone call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- 15 May 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pakistan or Somalia registered as country of birth
- Invited to the first round of faecal screening test in the National Colorectal Cancer Screening Program in Norway
- Reminder letter sent after no received faecal sample in the screening laboratory within six weeks from mailing of the faecal screening sample kit from the screening organizers
Who cannot join
- Individuals whose mailed reminder letter is returned to sender
- Individuals whose faecal screening sample is registered in the screening laboratory 1) on the same day or the day after the reminder letter is sent out (applies to those who receive a digital reminder), or 2) on the same day or up to three days after the reminder letter is sent out (applies to those who receive a mailed reminder letter)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Access to Colorectal Cancer Screening Among Immigrants
The goal of this randomized trial is to test the effect of a reminder telephone call in the official native language in the country where the invitee is born, in addition to the reminder letter in Norwegian on participation in the National Colorectal Cancer Screening Program in Pakistani and Somalian immigrants, compared to the reminder letter in Norwegian only.
The main question it aims to answer is:
Read more
•Does a reminder telephone call in the language of origin increase participation in colorectal cancer screening in Pakistani and Somalian immigrants in Norway?
Participants in this trial are individuals with Pakistan or Somalia as their country of birth invited to the National Colorectal Cancer Screening Program, who have not participated by mailing a faecal sample to the screening laboratory.
In the intervention group, the participants will be called in the official language in their country of origin, to inform about colorectal cancer screening, in addition to the reminder letter in Norwegian language sent to all non-participants.
Participants in the comparison group will only be sent the reminder letter in Norwegian language.
The researchers will compare differences in the participation rate in the National Colorectal Cancer Screening Program between the intervention and comparison groups.
Read the detailed description
The aim of the project is to study the effect of reminding non-participant Somalian and Pakistani immigrant groups by a telephone call in the official native language in the country of birth, in addition to the reminder letter in Norwegian, by running a randomized trial. The outcome is participation in the National Colorectal Cancer Screening Program by taking a faecal sample with a mailed test kit.
The design of the trial is a parallel two-arm intervention study, with 1:1 randomization to intervention or control.
The intervention consists of a reminder both as telephone call in the native language of the non-participant's country of birth and the standard reminder letter (sent digitally or in mail) in Norwegian from the National Colorectal Cancer Screening Program. The timepoint of the telephone call will be during a week after the reminder letter has been mailed to the non-participant. The information to be given in the reminder call will include the same information as given in the reminder letter, but it will be asked additionally whether the invitee has understood the invitation and whether he/she has any questions. A new faecal sample kit will be sent on request.
The control arm will consist of screening practice as usual, which is the standard reminder letter in Norwegian from the National Colorectal Cancer Screening Program. A new faecal sample kit will be sent on request.
Masking: There is no masking in the trial. Allocation: This is a randomized trial. Participants are assigned to intervention groups by chance, using Random Integer Generator in random.org, when being assigned to the list of persons to whom a reminder is sent to.
Participation rate in the National Colorectal Cancer Screening Program will be compared between the intervention and control arms. That is, comparison of the proportion of individuals who send a faecal sample in mail to the screening laboratory.
- Conditions
- Cancer Colorectal
- Being tested
- Reminder telephone call
- Keywords
- colorectal cancer screening, immigrant, participation, intervention, reminder, information
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder telephone callBehavioural
A reminder telephone call with information on colorectal cancer screening in the language of origin (Urdu or Somali) in addition to the reminder letter in Norwegian (usual care)
| Study group | Role | What they receive |
|---|---|---|
| Reminder telephone call | Active comparator | A reminder telephone call with information on colorectal cancer screening in the language of origin (Urdu or Somali) in addition to the reminder letter in Norwegian (usual care) Receives: Behavioral: Reminder telephone call |
| Comparison | No intervention | The reminder letter in Norwegian (usual care) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
First round screening participation
Participation rate in the first colorectal cancer screening round. For each randomized individual, it is measured whether or not the faecal sample is sent to the screening laboratory by the participant in the first round of screening (yes/no).
Measured: within 12 weeks (84 days) from mailing of the screening reminder letter
Secondary outcomes (1)
Overall screening participation
Participation rate in all five rounds of colorectal cancer screening. For each randomized individual, it is measured to which degree faecal samples are sent to the screening laboratory by the participant (yes, in all five rounds of screening/yes, in 1-4 rounds of screening/no).
Measured: within six months from mailing of the last screening round invitation (of up to five rounds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 May 2024
- Primary completion31 Dec 2024
- Study completion30 Mar 2025
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 ColorectalStudies of the same condition, open and under way.
- 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
- There is an intervention group and a comparison group in the study.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paula Berstad, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324409
- Sponsor's protocol ID
- H-350
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iqbal N, Bhargava S, Hofvind S, Farah KS, Holme O, Botteri E, Berstad P. Effect of reminder phone calls in the language of origin on colorectal cancer screening participation among immigrants in Norway: a randomised controlled trial. Lancet Reg Health Eur. 2026 Mar 13;63:101648. doi: 10.1016/j.lanepe.2026.101648. eCollection 2026 Apr.
PubMed 41868191
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Colorectal Cancer Screening Among Immigrants
- ClinicalTrials.gov ID
- NCT06324409
- Acronym / sponsor ID
- H-350
- Conditions
- Cancer Colorectal
- Keywords
- colorectal cancer screening, immigrant, participation, intervention, reminder, information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 22 Mar 2024 (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 goal of this randomized trial is to test the effect of a reminder telephone call in the official native language in the country where the invitee is born, in addition to the reminder letter in Norwegian on participation in the National Colorectal Cancer Screening Program in Pakistani and Somalian immigrants, compared to the reminder letter in Norwegian only.
The main question it aims to answer is:
•Does a reminder telephone call in the language of origin increase participation in colorectal cancer screening in Pakistani and Somalian immigrants in Norway?
Participants in this trial are individuals with Pakistan or Somalia as their country of birth invited to the National Colorectal Cancer Screening Program, who have not participated by mailing a faecal sample to the screening laboratory.
In the intervention group, the participants will be called in the official language in their country of origin, to inform about colorectal cancer screening, in addition to the reminder letter in Norwegian language sent to all non-participants.
Participants in the comparison group will only be sent the reminder letter in Norwegian language.
The researchers will compare differences in the participation rate in the National Colorectal Cancer Screening Program between the intervention and comparison groups.
Detailed description
The aim of the project is to study the effect of reminding non-participant Somalian and Pakistani immigrant groups by a telephone call in the official native language in the country of birth, in addition to the reminder letter in Norwegian, by running a randomized trial. The outcome is participation in the National Colorectal Cancer Screening Program by taking a faecal sample with a mailed test kit.
The design of the trial is a parallel two-arm intervention study, with 1:1 randomization to intervention or control.
The intervention consists of a reminder both as telephone call in the native language of the non-participant's country of birth and the standard reminder letter (sent digitally or in mail) in Norwegian from the National Colorectal Cancer Screening Program. The timepoint of the telephone call will be during a week after the reminder letter has been mailed to the non-participant. The information to be given in the reminder call will include the same information as given in the reminder letter, but it will be asked additionally whether the invitee has understood the invitation and whether he/she has any questions. A new faecal sample kit will be sent on request.
The control arm will consist of screening practice as usual, which is the standard reminder letter in Norwegian from the National Colorectal Cancer Screening Program. A new faecal sample kit will be sent on request.
Masking: There is no masking in the trial. Allocation: This is a randomized trial. Participants are assigned to intervention groups by chance, using Random Integer Generator in random.org, when being assigned to the list of persons to whom a reminder is sent to.
Participation rate in the National Colorectal Cancer Screening Program will be compared between the intervention and control arms. That is, comparison of the proportion of individuals who send a faecal sample in mail to the screening laboratory.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There is an intervention group and a comparison group in the study.
| Arm | Type | Receives |
|---|---|---|
| Reminder telephone call | Active comparator | Behavioral: Reminder telephone callA reminder telephone call with information on colorectal cancer screening in the language of origin (Urdu or Somali) in addition to the reminder letter in Norwegian (usual care) |
| Comparison | No intervention | –The reminder letter in Norwegian (usual care) only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pakistan or Somalia registered as country of birth
- Invited to the first round of faecal screening test in the National Colorectal Cancer Screening Program in Norway
- Reminder letter sent after no received faecal sample in the screening laboratory within six weeks from mailing of the faecal screening sample kit from the screening organizers
Key exclusion criteria (2 listed)
- Individuals whose mailed reminder letter is returned to sender
- Individuals whose faecal screening sample is registered in the screening laboratory 1) on the same day or the day after the reminder letter is sent out (applies to those who receive a digital reminder), or 2) on the same day or up to three days after the reminder letter is sent out (applies to those who receive a mailed reminder letter)
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 |
|---|---|---|
| Reminder telephone callA reminder telephone call with information on colorectal cancer screening in the language of origin (Urdu or Somali) in addition to the reminder letter in Norwegian (usual care) | Behavioural | Reminder telephone call |
Primary outcome
First round screening participation
Time frame: within 12 weeks (84 days) from mailing of the screening reminder letter
Participation rate in the first colorectal cancer screening round. For each randomized individual, it is measured whether or not the faecal sample is sent to the screening laboratory by the participant in the first round of screening (yes/no).
1 secondary outcome
Overall screening participation
Time frame: within six months from mailing of the last screening round invitation (of up to five rounds)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Derived from this study: PubMed 41868191Iqbal N, Bhargava S, Hofvind S, Farah KS, Holme O, Botteri E, Berstad P. Effect of reminder phone calls in the language of origin on colorectal cancer screening participation among immigrants in Norway: a randomised controlled trial. Lancet Reg Health Eur. 2026 Mar 13;63:101648. doi: 10.1016/j.lanepe.2026.101648. eCollection 2026 Apr.
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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 Reminder telephone call in people with Cancer Colorectal, run by Norwegian Institute of Public Health 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 15 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First round screening participation (time frame: within 12 weeks (84 days) from mailing of the screening reminder 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 NCT06324409, 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 15 Apr 2025.