Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04966377 |
| Other study ID # |
2020/132 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study, which is designed according to the experimental model with randomized pre-test
and post-test control group, will be carried out with Syrian women who apply to Empowered
Migrant Health Center in İstanbul province, Sultanbeyli district, where Syria citizens are
immigranted. The population of the study consisted of all Syrian women aged 40-69 under
temporary protection who came to the Empowered Migrant Health Center at the time of the
research. The working group will be composed of 80 Syrian women who meet the selection
criteria. According to the sources, the frequency of breast cancer screening in Turkey is
taken as 15%; For the study at 95% confidence level, d=0,6 was taken and n=136 sample size
was taken. Considering that there may be those who left during the research period, 14 women
will be taken as substitutes and the sample will be completed to a total of 150 in order to
increase the power of representing the universe. A personal questionnaire prepared by the
researcher in line with the literature, Health Belief Model Scale, Mammography Self-Efficacy
Scale, Champion Breast Cancer Fear Scale, Breast Self Examination Checklist Form, will be
administered to Syrian women under temporary protection who applied to the empowered migrant
health center and agreed to participate in the study.According to the sample pool formed by
the women included in the study, the participants were assigned to 2 groups as experiment and
control with the "Research Randomizer" program. Each group will be determined as 75 people. A
4-week training program will be applied to the experimental group. The women in the
experimental group will be given a self-breast examination control calendar after their first
training. Afterwards, motivational interviews will be held once a month for the second and
third months. A "Nurse-managed screening consultancy telephone support line" will be
established for Syrian women within the scope of the Nurse Navigation Program. Reminder phone
calls will be made 4 times a week. Personal questionnaire, Health Belief Model Scale,
Mammography Self-Efficacy Scale, Champion Breast Cancer Fear Scale, Breast Self Examination
Checklist Form, Post-Training Screening Behavior Follow-up Form will be administered to the
experimental and control groups as a post-test.
Description:
In this study, it is aimed to present an innovative approach in ensuring the participation of
Syrian women under temporary protection in breast cancer screening. For this purpose, Nurse
Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS) will
be applied to affect the health beliefs of Syrian women. The research is carried out with a
randomized controlled double-blind pre-test post-test control group. The randomized clinical
trial was based on the guidelines proposed by the Consolidated standard of Reporting
TrialsCONSORT 2010. The data of the research will be collected at Istanbul/Sultanbeyli
Empowered Migrant Health Center between June and October 2021. Introductory Information
Questionnaire, Health Belief Model Scale, Mammography Self-Efficacy Scale, Champion Breast
Cancer Fear Scale and Breast Self-Examination Checklist Form, prepared by the researcher in
line with the literature, will be applied to women who apply to this immigrant health center
and agree to participate in the research. Pre-tests will be given to the experimental and
control groups in a training room at the Empowered Migrant Health Center. Data collection
will take approximately 15-20 minutes. Pre-tested Syrian women will be randomly assigned to
the sample pool to be divided into experimental and control groups. Romany women will be
divided into experimental and control groups using the Simple Random Method.
Data Collection Tools Personal questionnaire;Introductory features questionnaire consisting
of 32 questions developed by the researchers in line with the literature; It questions
women's socio-demographic characteristics (age, number of children, educational status,
etc.), their beliefs about early diagnosis practices, their genetic characteristics, and
their status regarding early diagnosis practices for cancer. The introductory features
questionnaire was translated into Arabic in a way that individuals can understand.
Health Belief Model Scale: The scale, which is used to determine the beliefs and attitudes of
individuals regarding breast cancer, BSE, CBE and Mammography, was developed by Champion in
1984 and was last revised in 1999. The validity and reliability of the Arabic version of the
revised Champion Health Belief Model Scale was conducted by Mikhail and Petro-Nustas. The
Cronbach's Alpha value of the original scale was reported to be 0.65-0.90, and test-retest
correlations of 0.40-0.68. According to the validity and reliability study of the scale for
Syrian women, the number of items; sensitivity perception (5-25 points), caring perception
(8-40 points), health motivation perception (6-30 points), BSE benefit perception (6-30
points), BSE perception of obstacles (7-35 points), self- efficacy perception (9-45 points),
mammography barrier and benefit perception (12-60 points), and clinical breast examination
barrier and benefit perception (9-45 points) sub-dimensions. The scale is in a 5-point Likert
type and for each item, between 1 and 5, 1 is "very bad"; 2 "bad"; 3 "medium"; 4 "good"; 5
was rated as "very good". Higher scores mean that sensitivity and caring increase, health
motivation for health motivation, benefits for benefit perception, barriers for obstacle
perception, and self-efficacy for self-efficacy are perceived high. Scoring is reversed for
items in the obstacles sub-dimension in the scale. A high total score in the scale for the
sub-dimensions other than the barriers, explains that the individual's perceptions of health
related to breast cancer screening behaviors are high and the rate of exhibiting the behavior
will be high. Written permission was obtained from the author to use the Health Belief Model
Scale.
Mammography Self-efficacy scale: The scale was developed by Champion et al in 2005. The
Chronbach Alpha value is specified as 0.87 . The Arabic validity-reliability study of the
scale was conducted by Al-Zalabani. The scale consists of 10 items and aims to assess women's
perceived self-efficacy for mammography screening. In the Arabic evaluation of the scale,
5-point Likert-type scaling ranging from 1 to 5 "strongly disagree", "disagree", "undecided",
"agree", "strongly agree" method was used. The total possible score ranges from 10 to 50
points, indicating a higher level of self-efficacy as the total score increases. Al-Zalabani
found the Cronbach's Alpha value of the scale to be 0.88.
Champion Breast Cancer Fear Scale: Champion Breast Cancer Fear Scale (CMKKÖ) is an 8-item
measurement tool developed by Champion. This scale determines the relationship between breast
cancer and mammography behavior and women's emotional responses and is used to screen for
breast cancer fear behavior. Alyami et al. In 2019, the scale was translated into Arabic and
its validity and reliability study was carried out and published in 2021. The scale is
five-point Likert type. Responses to the scale are scored as "strongly disagree" 1 point,
"disagree" 2 points, "undecided" 3 points, "agree" 4 points, "strongly agree" 5 points. The
lowest score that can be obtained from the scale is 8, and the highest score is 40. A high
score indicates a high fear of breast cancer. For the Champion Breast Cancer Fear Scale
Arabic, Cronbach's correlation coefficient is 0.94.
Breast self-exam checklist form: This checklist form was made in order to determine the
practices that the individuals participating in the research knew about breast
self-examination before nursing care and the behaviors they gained after nursing care.
As a result of the research, the data obtained from all tests will be evaluated and reported
in the SPSS package program. Descriptive statistics, paired t test, mc nemar test and
correlation analysis will be used in the evaluation of the data.
Before starting the study, ethics committee approval (number: 220/132) from the Social and
Human Sciences Ethics Committee of Ondokuz Mayıs University and permission from the Migration
Policy and Projects Department of the General Directorate of Migration Management (No:
62103649000E. 20374) were obtained. Later, institutional permission was obtained from the
Istanbul Provincial Health Directorate (E-15916306-604.01.01) to practice in the Strengthened
Migrant Health Center. Before the start of the study, the women participating in the study
were informed about the purpose of the study and their written consent was obtained with the
Informed Consent Form.
