Cervical CancerNCT03076879
Increasing Participation in Cervical Cancer Screening and Risk for Beliefs/Attitudes Among Women at Risk
A study testing Promoting participation in cervical cancer screening in people with Cervical Cancer, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Promoting participation in cervical cancer screening
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 19 Jun 2017
- 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 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being literate
- Have not received any training on cervical cancer before
Who cannot join
- Being pregnant or postpartum quarterly
- Have already been diagnosed with any cancer
- Not having sexual experience
- Having undergone hysterectomy operation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Promoting participation in cervical cancer screening
- Keywords
- Cervical Cancer, Pap smear, Screening, Beliefs, Attitude, Nursing
- Medical subject headings
- Uterine Cervical Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting participation in cervical cancer screeningBehavioural
Also called Education, Counseling, Home Visit, Reminder by phone
Nursing education: Women in the experimental group will be trained three times in total, one for the cervical cancer screening and the other two for the individual.
Reminders by phone; Short messages and calls will be reminiscent of women's participation in cervical cancer screenings.
Home visit; The content of the training is the key to cervical cancer and screening. After the group training, it is aimed to be an interactive education and counseling service in the form of question-answer method which is not understood by home visiting method.
Brochure; The brochure for cervical cancer and screening will be given after group training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The selected ASM was associated with risk factors related to direct cervical cancer in Turkey (using age 5 or older oral contraceptives, having three or more children, initiating sexual intercourse 16 years or older, at least one parenthesized smear test between 40-55 years) And randomly assigned to the experimental group to promoting participation in cervical cancer screening Receives: Behavioral: Promoting participation in cervical cancer screening |
| Control Group | No intervention | The selected ASM is the most common and associated with direct cervical cancer-related risk factors in Turkey (using oral contraceptives for longer than five years, having three or more children, starting sexual intercourse at the age of 16 and before, Women who are randomly assigned to the control group of women who have at least one pap smear test between the ages of 40 and 55 and who have at least one pap smear test in the family (especially a mother and a sister) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pap Smear Management Related Evaluation Form
This form, prepared by the researcher, consists of four questions that question the participation status of the scan and which application is more effective. This form will only be applied in the final test.
Measured: 14 weeks after group training
Secondary outcomes (2)
Cervix Cancer And Pap-Smear Test Health Belief Model Scale
It consists of 35 items in total. There are 5 sub-dimensions of related scale. These; Benefit and motivation perception (8), The obstacle sensation 14, The perception of seriousness of cervical cancer (7),Sensitivity sense (3) And health motivation (3). In the scale, the answer is 1, "I do not agree" 2, "I am undecided" 3, "I agree" 4 and "I strongly agree" 5.No item on the scale is scored in reverse. In the evaluation, scores are obtained for each individual as the number of sub-dimensions. From the subscales of the scale, at least 8, at most 40 for Pap smear benefit and motivation; Pap smear for at least 14, at most 70; At least 7, at most 35 for cervical cancer care / seriousness; At least 3, at most 15 for cervical cancer susceptibility and at least 3, at most 15 for cervical cancer health motivation. The increase in the scores means that the sensitivity, the importance and health motivation increase; Benefits for benefit perception, and high perception for obstacle perception.
Measured: Before work begins and 14 weeks after group training
Healthy Lifestyle Behavior Scale (Health Responsibility)
The scale measures health-promoting behaviors associated with the individual's healthy lifestyle. This scale, consisting of 52 items, has a total of six sub-dimensions including spiritual development, health responsibility, physical activity, nutrition, interpersonal relations and stress management. All of the items of the scale are indicative and quartile likert (never (1), sometimes (2), often (3), regularly (4)). Only the health responsibility sub-dimension will be used in this study.
In the sub-dimension of health responsibility, the lowest score is 9 and the highest score is 36. The lower the score, the lower the health responsibility, and as the score increases, the health responsibility also increases.
Measured: Before work begins and 14 weeks after group training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start15 Mar 2017
- Primary completion22 Mar 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BUSRA ALTINEL, Selcuk University
- Investigators
- Belgin Akın, PhD, Study director, SELÇUK ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076879
- Sponsor's protocol ID
- 2014-066
- Status last verified
- Sep 2017
- First submitted
- 26 Feb 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03076879
- Acronym / sponsor ID
- 2014-066
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Pap smear, Screening, Beliefs, Attitude, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Promoting participation in cervical cancer screeningThe selected ASM was associated with risk factors related to direct cervical cancer in Turkey (using age 5 or older oral contraceptives, having three or more children, initiating sexual intercourse 16 years or older, at least one parenthesized smear test between 40-55 years) And randomly assigned to the experimental group to promoting participation in cervical cancer screening |
| Control Group | No intervention | –The selected ASM is the most common and associated with direct cervical cancer-related risk factors in Turkey (using oral contraceptives for longer than five years, having three or more children, starting sexual intercourse at the age of 16 and before, Women who are randomly assigned to the control group of women who have at least one pap smear test between the ages of 40 and 55 and who have at least one pap smear test in the family (especially a mother and a sister) |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being literate
- Have not received any training on cervical cancer before
Key exclusion criteria (4 listed)
- Being pregnant or postpartum quarterly
- Have already been diagnosed with any cancer
- Not having sexual experience
- Having undergone hysterectomy operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting participation in cervical cancer screeningAlso: Education, Counseling, Home Visit, Reminder by phoneNursing education: Women in the experimental group will be trained three times in total, one for the cervical cancer screening and the other two for the individual. Reminders by phone; Short messages and calls will be reminiscent of women's participation in cervical cancer screenings. Home visit; The content of the training is the key to cervical cancer and screening. After the group training, it is aimed to be an interactive education and counseling service in the form of question-answer method which is not understood by home visiting method. Brochure; The brochure for cervical cancer and screening will be given after group training. | Behavioural | Intervention group |
Primary outcome
Pap Smear Management Related Evaluation Form
Time frame: 14 weeks after group training
This form, prepared by the researcher, consists of four questions that question the participation status of the scan and which application is more effective. This form will only be applied in the final test.
2 secondary outcomes
Cervix Cancer And Pap-Smear Test Health Belief Model Scale
Time frame: Before work begins and 14 weeks after group training
Healthy Lifestyle Behavior Scale (Health Responsibility)
Time frame: Before work begins and 14 weeks after group training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belgin Akın, PhD study director
SELÇUK ÜNİVERSİTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting participation in cervical cancer screening in people with Cervical Cancer, run by Selcuk University at 1 site in Turkey (Türkiye).
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 4 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pap Smear Management Related Evaluation Form (time frame: 14 weeks after group training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2019.