Clinical trial NCT03076879: Increasing Participation in Cervical Cancer Screening and Risk for Beliefs/Attitudes Among Women at Risk
Official title: The Effect of Nursing Interventions on Women's Cervical Cancer Risk for Beliefs / Attitudes and Attendance to Screening Programme; Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Pap smear
Screening
Beliefs
Attitude
Nursing
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 114
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to evaluate the effectiveness of nursing interventions aimed at the early detection of cervical cancer, health belief and participation in the screening of women aged 40-55 at risk for the purpose of cervical cancer, One-way blind pre-test and post-test randomized controlled trial.

Detailed description: Cervical cancer is the 4th most common cancer type in the world, among women, in all age groups. Cervical cancer is a high-risk disease, and every two minutes, a woman loses her life due to cervical cancer. In Turkey, among the most common cancers among all age groups among women, 9th is the 5th among the most common cancers in the 25-49 age group. Cervix cancer is a type of cancer that can be prevented and treated at an early stage. Because cervical cancer has a long preclinical period, it has an early diagnosis possibility. For this reason, cervical cancer is one of the cancers recommended by World Health Organization (WHO) screening programs. In countries where regular screenings have been conducted, death rates from cervical cancer have decreased. In developing countries, high incidence and mortality continue due to the inadequacy of screening programs.

The first step in the early diagnosis of cervical cancer is usually the result of an abnormal Pap smear test. The Pap smear test is an ideal cytologic screening test used for screening because it can identify early onset of a cellular change that may be a starting point for cervical cancer and is cost effective. The number of women who have had the Pap smear test, which is so important in early diagnosis, is not at a level all over the world and in our country. In developed countries, cervical cancer screening rates are over 60%, while in underdeveloped and developing countries this rate is below 20%. In our country, the rate of not having any pap smear test over the age of 15 years is 77.9%.

Studies have shown that when women with cervical cancer are diagnosed early, their life span is prolonged and their chances of survival increase. Early diagnosis of cervical cancer is a simple, feasible and economical method. Women's lack of knowledge, worries about negative test results, and their reasons for not having a Pap smear test are among the reasons. Along with being semi-empirical studies in our country, most are based solely on education and do not involve a risk group approach. In addition, there was no randomized controlled trial (RCT) with evidence in the definition of causal relationship in our country. For this reason, determining the factors affecting the early diagnosis behavior of women, planning and implementing nursing interventions for these factors will contribute to the improvement of early diagnosis behavior of women with cervical cancer. In this respect, health education for cervical cancer and early diagnosis to be made to women in the risk group will have made a unique contribution to RCT including motivational initiatives and home visits.

In order to evaluate the effectiveness of nursing interventions aimed at early detection of cervical cancer, health beliefs and participation in scans in women aged 40-55 years at risk for prognostic cervical cancer, One-way blind pre-test - final test was planned as RCT. In this context, women in the risk group of 40-55 years of age with cervical cancer in the project will constitute the universe of RCT. No pap smear test, no previous training for cervical cancer, no previous hysterectomy, no previous cancer diagnosis, no current or past sexual life and at least one of the identified risk factors Will have women involved. Women who are in the risk group for cervical cancer and meet the inclusion and exclusion criteria of the study will be randomly assigned to the experimental and control groups. In the experimental group, cervical cancer will constitute nursing initiatives for health education, home visits, problem-specific counseling and phone reminders for women at risk. Women in the experimental group will receive a 15-week follow-up. Two reminders will be used to increase motivation between home visits and trainings. The effectiveness of counseling and training programs will be assessed by means of data collection tools that will be used for pretest / posttest for women in the experimental and control groups and the data form prepared by the researcher in the light of the literature.

Depending on the project, women are expected to participate in the cervical cancer screening program. Home visits, trainings, counseling and reminders by phone will raise awareness levels of women at risk for cervical cancer as a result. As a result, increased participation of women in the risk group in screening programs will increase the probability of early diagnosis and reduce cervical cancer mortality, reduce the cost and improve the health of the community.

Eligibility criteria: Inclusion Criteria:

* Being literate
* Have not received any training on cervical cancer before

Exclusion Criteria:

* Being pregnant or postpartum quarterly
* Have already been diagnosed with any cancer
* Not having sexual experience
* Having undergone hysterectomy operation

Primary outcomes:
measure: Pap Smear Management Related Evaluation Form
timeFrame: 14 weeks after group training
Secondary outcomes:
measure: Cervix Cancer And Pap-Smear Test Health Belief Model Scale
timeFrame: Before work begins and 14 weeks after group training
measure: Healthy Lifestyle Behavior Scale (Health Responsibility)
timeFrame: Before work begins and 14 weeks after group training
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selçuk University
state: Selçuklu
Study officials:
affiliation: SELÇUK ÜNİVERSİTESİ
name: Belgin Akın, PhD
role: STUDY_DIRECTOR
References: