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Cervical CancerNCT03155581

Increasing Attendance to Cervical Cancer-screening Among Immigrants

A study testing User intervention and Health professional intervention in people with Cervical Cancer, run by University of Bergen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Read more about this study

Who is it for?
Ages 25 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
User intervention and Health professional intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
No sites listed yet
Study dates
1 Feb 2016to 30 Jun 2018
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 25 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For the women: Women from Somalia and Pakistan living in the intervention areas
  • For the health professionals: GPs working in the intervention areas

Who cannot join

None listed.

About this study

Official title: A Community-based Health Intervention Trial to Increase Attendance to Cervical Cancer-screening Program Among Immigrants in Norway.

Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Adapting selected services to the individual cultural and religious background is necessary to reduce health inequalities and provide effective health care and is dependent on the active involvement of users. In this proposal the investigators present a community-based health intervention trial with two parallel interventions aimed at increasing participation of immigrant women to the existing cervical cancer-screening program. Through this study, the investigators will provide new practice-based knowledge and a firmer evidence base to improve health interventions that can contribute to equal health care and good health for all - including the immigrant population.

Based on identified barriers and factors that influence the interactions between immigrants and health care professionals for screening of cervical cancer in Norway, the investigators have develop two adapted interventions. One strategy will target immigrant women, and the other one will focus on general practitioners. Thus, this proposal will specifically contribute to the development of personalized health prevention interventions for the most common cancer-screening program in Norway, with a focus on immigrant's personal circumstances and health care needs.

Read the detailed description

Goals and objectives of the project The present study is designed to evaluate the effectiveness of two different community-based strategies to increase the attendance to the cervical cancer screening prevention program. Interventions have been developed together with stakeholders and conducted in two different geographical areas in Norway. Each intervention group will be compared to a control population in the same county in the first place. The main outcome to compare will be the percentage of women in each group attending to the screening program. However, the investigators will not only focus on this quantitative outcome, but also on the underlying processes determining how communities and individuals change their behaviour.

Secondly, the effect of the interventions measured quantitatively will be compared to each other in order to be able to prioritise one of the two strategies if needed, although strategies will probably be complementary. A particular interest of the interventions is to examine whether and how immigrant women respond to different intervention strategies.

Methods This study is designed as a community-based health intervention trial. A key feature of such trials is the allocation of intact communities or clusters of individuals rather than individuals themselves to different intervention groups.

The study will rely on both quantitative and qualitative evaluation of the interventions. For the quantitative part,each of the two interventions will be compared to its control. In addition, the effects of the interventions will be compared. Additionally, to know how the interventions increased (or not) attendance to the screening program post-intervention focus groups among intervention subjects will be conducted.

Interventions, participants and participating areas Two different intervention strategies have developed, one of them meant to increase awareness and attendance among users, and the other one targeting health professionals.

  1. User intervention Area and design The developed User intervention will be implemented in the counties of Akershus and Buskerud. Women from Somalia and Pakistan were chosen as targets for this intervention after previous analyses for register data. Sample size was calculated for an increase in cancer screening participation from 0.45 to 0.55 with 80% power and 5% significance level. The investigators tried several intra class correlation (ICC) levels, and ended dividing the area in 16 clusters that were matched according to the calculated number of female immigrants aged 20 to 66 from Somalia and Pakistan. After assuring that pairs were not naturally linked by a mosque or other natural known gather centre for these populations, clusters were randomly assigned to intervention or control groups. Participants All women from Somalia and Pakistan living in the intervention clusters compose the intervention groups; immigrant women from the same countries of origin living in control clusters will be control participants. It is estimated that 625 and 915 women in screening age from Somalia and Pakistan respectively live in the study area (Akershus and Buskerud). Approximately half part of the women from each country will be in the intervention clusters. Intervention Bilingual key women from the two chosen countries were recruited and trained as peer educators for their respective communities to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening. The strategy to achieve these goals relied upon meetings with the women organised according to their practical needs, using videos and other interactive materials.
  2. Heath professional intervention Area The developed Heath professional intervention will be implemented in Bergen. Sample size was calculated for an increase in cancer screening participation for non-Western immigrants (all groups together) from 0.45 to 0.55 with 80% power and 5% significance level. The investigators tried several intra class correlation (ICC) levels, and finally divided the area in 20 clusters that were matched according to the cluster size and the calculated number of female non-Western immigrants aged 20 to 66. The clusters were thereafter randomly assigned to intervention or control groups. Participants All General practitioners working in the intervention cluster areas were assigned to the intervention group; similarly, health professionals working in the other clusters will be chosen as controls. Women will for the analyses be linked to their general practitioner through the General Practice Database. Intervention Based on the existing evidence and on interviews conducted with health professionals, an appropriate intervention was developed to increase awareness of the health professionals involved in screening working in the chosen areas. Health professionals in the intervention areas will be contacted by letter and a personal appointment was made to explain the intervention. No change in "screening as usual" will be implemented for health professionals working in the control areas.
  3. Post-intervention qualitative studies Among participants included in the intervention areas, focus groups/in depth-interviews will be conducted right after the interventions are implemented among both users and health professionals to understand whether and how each of the interventions worked.

Measurements The study relies on both quantitative and qualitative evaluation of the interventions.

  1. Outcome information on screening attendance for intervention and control groups will be obtained from the Norwegian Cytology registry, where all pap smears taken in Norway are registered. The leader of the Norwegian Cytology register is part of the Reference group for this study, and this register can provide data for the variables Morphology (if the test is taken, if it is normal or pathological) and date for test for all women in Norway after the necessary permissions are given. This register will be then linked at the individual level to the Norwegian National Registry in order to obtain information regarding immigrant background, country of origin as explained below, reason for migration and length of stay in Norway for all 25 to 69 years old registered in Norway, in addition to other socioeconomic variables (age, education, income level, work status, cluster area for those in intervention and control areas, geographical centrality, civil status, husbands' immigrant background and GP's immigrant background) that will be used to adjust our results, and to two variables from the GP database (GP's age and gender) to identify the GPs in the intervention and control groups in the Health professional strategy. Data will be linked by Statistics Norway before being accessible to the researchers. However, since ethnicity is considered sensitive data, and in order to make the dataset completely anonymous for the research group, we will only apply for the following groups with regard to country of origin (see page 1 for approximate numbers): Norway, Western Europe, Eastern Europe, Middle-East, South-East, South Asia, Africa, North America, Central and South America, Poland, Sweden, Pakistan and Somalia. As explained below, data will be obtained for several years (2012-2018) in order to be able to distinguish secular trends in attendance to cervical screening versus the effect due to our intervention. Data will be stored in a secure server at the University of Bergen (BIOS, Core Facility for Biostatistics and Data Analyses) in an anonymised form.
  2. In addition, the process of how communities and individuals change their behaviour will be studied using a qualitative approach to the intervention groups after the interventions. These data will do not include any information that can lead to personal identification of the women.
Conditions
Cervical Cancer
Being tested
User intervention, Health professional intervention
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • User interventionBehavioural

    To make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation

  • Health professional interventionBehavioural

    To provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation

Study groups in NCT03155581
Study groupRoleWhat they receive
User interventionOtherBilingual key women from Somalia and Pakistan trained as peer educators for their respective communities will meet the women to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening during meetings with the women organised according to their practical needs, using videos and interactive material
Receives: Behavioral: User intervention
Health professional interventionOtherGeneral practitioners working in the intervention areas are contacted by letter and an appointment is made for a short meeting to increase awareness of the health professionals involved in screening working in the chosen areas. Material is given(posters and reminding objects) to remind practitioners of the intervention and invite women attending to the center to make an appointment with their GP. No change in "screening as usual" will be implemented for health professionals working in the control areas.
Receives: Behavioral: Health professional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participation in cervical cancer screening

    Registered in national cancer register (yes/no), if the woman has been registered with a Pap-smear or not

    Measured: 1 year

Secondary outcomes (1)
  1. Process of behavior change

    Interviews with women and health professionals: How the intervention has worked/not worked

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start1 Feb 2016
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
One intervention targeting women, the other one targeting health professionals.
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155581
Sponsor's protocol ID
2015/1156
Status last verified
Dec 2018
First submitted
11 May 2017
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan

Publications

  • Qureshi SA, Igland J, Moen K, Gele A, Kumar B, Diaz E. Effect of a community-based intervention to increase participation in cervical cancer screening among Pakistani and Somali women in Norway. BMC Public Health. 2021 Jun 30;21(1):1271. doi: 10.1186/s12889-021-11319-1.

    PubMed 34193096
  • Moen KA, Kumar B, Igland J, Diaz E. Effect of an Intervention in General Practice to Increase the Participation of Immigrants in Cervical Cancer Screening: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e201903. doi: 10.1001/jamanetworkopen.2020.1903.

    PubMed 32236530
  • Qureshi SA, Gele A, Kour P, Moen KA, Kumar B, Diaz E. A community-based intervention to increase participation in cervical cancer screening among immigrants in Norway. BMC Med Res Methodol. 2019 Jul 12;19(1):147. doi: 10.1186/s12874-019-0795-8.

    PubMed 31299912

Questions about this trial

What is this clinical trial studying?

A study testing User intervention and Health professional intervention in people with Cervical Cancer, run by University of Bergen.

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 0 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Participation in cervical cancer screening (time frame: 1 year). 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 NCT03155581, which also lists 3 linked publications.

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 19 Dec 2018.

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