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Increasing Participation in Cervical Cancer Screening and Risk for Beliefs/Attitudes Among Women at Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076879
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
BUSRA ALTINEL, Selcuk University

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Promoting participation in cervical cancer screening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blindness in the study will be done by data collectors and statisticians. The data will be collected by the assistant investigator who does not know who is in the experiment and control group and the data will be recorded on the computer by the assistant investigator without specifying the experiment and control group. The experimental and control groups will be codified by the co-investigator. The analysis of the data encoded by the groups will be done by a statistical expert. Data collectors, statistical analyzes and report writing will be blinded.
Primary Purpose: Prevention
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
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : March 22, 2017
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Intervention group
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
Behavioral: Promoting participation in cervical cancer screening

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.

Other Names:
  • Education
  • Counseling
  • Home Visit
  • Reminder by phone

No Intervention: Control Group
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cervix Cancer And Pap-Smear Test Health Belief Model Scale [ Time Frame: Before work begins and 14 weeks after group training ]
    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.

  2. Healthy Lifestyle Behavior Scale (Health Responsibility) [ Time Frame: Before work begins and 14 weeks after group training ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

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): NCT03076879


Locations
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Turkey
Selçuk University
Konya, Selçuklu, Turkey, 42100
Sponsors and Collaborators
Selcuk University
Investigators
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Study Director: Belgin Akın, PhD SELÇUK ÜNİVERSİTESİ

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Responsible Party: BUSRA ALTINEL, Research Assistant, Selcuk University
ClinicalTrials.gov Identifier: NCT03076879    
Other Study ID Numbers: 2014-066
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BUSRA ALTINEL, Selcuk University:
Cervical Cancer
Pap smear
Screening
Beliefs
Attitude
Nursing
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
Genital Diseases, Female