Nurse Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS)

NCT04966377 | Completed DMC

• 1 other identifier: 2020/132
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Syrian woman; Nurse navigation program; Early screening; Cancer; Health blief Model

Outcome Measures

Primary Outcomes (4)

• 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. The validity and reliability of the Arabic version of the revised Champion Health Belief Model Scale was conducted by Mikhail and Petro-Nustas. According to the validity and reliability study of the scale for Syrian women, the number of items; sensitivity perception (5-25), caring perception (8-40), health motivation perception (6-30), BSE benefit perception (6-30), BSE perception of obstacles (7-35), self- efficacy perception (9-45 ), mammography barrier and benefit perception (12-60), and clinical breast examination barrier and benefit perception (9-45) sub-dimensions. 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.

  4 months

• 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 (2019). 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" (1), "disagree" (2), "undecided" (3), "agree" (4), "strongly agree" (5) 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 (2019) found the Cronbach's Alpha value of the scale to be 0.88.

  4 months

• Champion Breast Cancer Fear Scale

  Champion Breast Cancer Fear Scale (CMKKÖ) is an 8-item measurement tool developed by Champion, et al., (2004). 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.

  4 months

• Motivational interview

  A motivational interview will be held with the participants in the experimental group about the beliefs and barriers of breast cancer early diagnosis practices. This assessment will be completed in 2 sessions separately for each individual.

  4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention Group First, pre-tests were applied to the women in the experimental group. A 4-week training program created by taking into account the cultural characteristics of Syrian women; Explaining breast health, Explaining breast structure, Cancer, Breast cancer, Early diagnosis and its importance, BSE application, CBE and mammography, Barriers on breast cancer, Cancer Early Diagnosis, Screening and Education Center. A 'Nurse-directed screening counseling telephone support line' will be established for the women in the experimental group. Then, motivational interviews will be applied to the women in the experimental group by the researcher, who emphasizes the importance of early diagnosis in line with the health belief model. Reminders will be made by phone every week in the 3rd month. The final tests will be held 4 months after the end of the training.

Behavioral: Nurse Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS)

Control Group

NO INTERVENTION

Pre-tests will be applied to the women in the control group. No intervention will be applied to the women in this group and post-tests will be performed 4 months after the pre-test.

Interventions

Nurse Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS) BEHAVIORAL

Nurse Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS), increasing awareness of Syrian women under temporary protection against breast cancer, decreasing their perception of barriers to screening tests, developing early diagnosis behaviors (such as BSE, CBE and mammography), increasing their self-efficacy and breast cancer fears are expected to be reduced.

Intervention Group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 40-69.
• Being a woman.
• Not having been diagnosed with breast cancer.
• Not doing BSE on a regular basis every month.
• Not having had CME and mammography in the last three years.
• Not to be pregnant, breastfeeding or postpartum.
• No history of breast cancer.
• Not having received training on breast cancer.
• To agree to participate in the research.
• Absence of a mental illness.
• Being literate, accessible and communicative.
• Not having a communication barrier
• Being registered with Sultanbeyli Empowered Migrant Health Center

You may not qualify if:

• Having a problem with breast cancer before.
• Having BSE, CBE or Mammography at regular intervals.
• Having had a mastectomy for any reason.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Sultanbeyli Empowered Migrant Health Center

Istanbul, Sultanbeyli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Birsen ALTAY, Doç. Dr.

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing Department

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 19, 2021
• Study Start: June 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

TU (1)