NCT06324409

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

March 5, 2024

Last Update Submit

April 11, 2025

Conditions

Keywords

colorectal cancer screeningimmigrantparticipationinterventionreminderinformation

Outcome Measures

Primary Outcomes (1)

  • 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).

    within 12 weeks (84 days) from mailing of the screening reminder letter

Secondary Outcomes (1)

  • Overall screening participation

    within six months from mailing of the last screening round invitation (of up to five rounds)

Study Arms (2)

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)

Behavioral: Reminder telephone call

Comparison

NO INTERVENTION

The reminder letter in Norwegian (usual care) only

Interventions

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)

Reminder telephone call

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, 0304, Norway

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Paula Berstad, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: There is an intervention group and a comparison group in the study.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 22, 2024

Study Start

May 15, 2024

Primary Completion

December 31, 2024

Study Completion

March 30, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations