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Increasing Attendance to Cervical Cancer-screening Among Immigrants

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ClinicalTrials.gov Identifier: NCT03155581
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
The Norwegian Centre for Minority Health Research
Information provided by (Responsible Party):
Esperanza Diaz, University of Bergen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: User intervention Behavioral: Health professional intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One intervention targeting women, the other one targeting health professionals.
Masking: None (Open Label)
Masking Description: Women under are those recruited in the intervention targeting women. In addition, 40 GP centers were recruited
Primary Purpose: Prevention
Official Title: A Community-based Health Intervention Trial to Increase Attendance to Cervical Cancer-screening Program Among Immigrants in Norway.
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
User intervention
Bilingual 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
Behavioral: User intervention
To make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation

Health professional intervention
General 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.
Behavioral: Health professional intervention
To provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation




Primary Outcome Measures :
  1. Participation in cervical cancer screening [ Time Frame: 1 year ]
    Registered in national cancer register (yes/no), if the woman has been registered with a Pap-smear or not


Secondary Outcome Measures :
  1. Process of behavior change [ Time Frame: 1 year ]
    Interviews with women and health professionals: How the intervention has worked/not worked



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   For the women, only females are subject to cervical cancer screening
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion Criteria:
  • For the women: Women from Somalia and Pakistan living in the intervention areas
  • For the health professionals: GPs working in the intervention areas
  • Exclusion Criteria: None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155581


Sponsors and Collaborators
University of Bergen
The Norwegian Centre for Minority Health Research
Investigators
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Principal Investigator: Esperanza Diaz, MD, PhD University of Bergen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Esperanza Diaz, Associate professor, University of Bergen
ClinicalTrials.gov Identifier: NCT03155581    
Other Study ID Numbers: 2015/1156
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases