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Skin Cancer, Self Skin Examination and Sun Protection Behaviors Training (RCT)

Primary Purpose

Skin Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The researcher will give training to the training group about skin cancer, skin self-examination and sun protection behaviors.
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Skin Cancer focused on measuring Skin Cancer,, Nursing, skin self-examination, sun protection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To agree to participate in the research,
  • Being a parent with a child between the ages of 10-14,
  • Being open to communication and cooperation,
  • Being able to read and write,

Exclusion Criteria:

  • Having a situation that may prevent written and verbal communication,
  • Not to have a child between the ages of 10-14,
  • Not agreeing to participate in the research,
  • Being illiterate,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Education (Intervention) Group

    Control Group

    Arm Description

    In the pretest phase of the research;Education group, those who signed the Informed Voluntary Consent Form and agreed to participate in the research will fill out the questionnaire.Data collection will take approximately 20-25 minutes.Afterwards,the researcher will give training to the training group about skin cancer,skin self-examination and sun protection behaviors.The tutorials are planned as a PowerPoint demonstration.The duration of the trainings is planned to take approximately 40minutes.The content of the training was prepared in line with the literature review.As a method;It will be in the form of narration,question and answer,brainstorming.Materials used in education;Colorfulbrochures on the subject will be given to reinforce the slide show and post-training information.A follow-up period of four months will be expected after the training given.At the end of the follow-up period,the training group will have to fill out the post-test questionnaires during the post-test phase.

    Control Group: In the pre-test phase of the study; control group parents, those who signed the Informed Consent Form and agreed to participate in the study will fill out the questionnaire. Data collection will take approximately 20-25 minutes. During the follow-up period (120 days), no intervention will be made on the control group. At the end of the follow-up period (120 days), the control group will have to fill out the post-test questionnaires during the post-test phase. Participants will be reminded of the purpose of the research. Approval of the Informed Consent Form will be received. Completing the post-test questionnaires will take approximately 20-25 minutes. A brochure training material will be distributed to the parents of the control group, in line with the principle of equality, immediately after the completion of the post-tests.

    Outcomes

    Primary Outcome Measures

    It is aimed to increase the Skin Cancer Sun Knowledge Scale scores of the education group.
    . After the training to be given to the training group, it is expected that the scores of the parents in the training group from the Skin Cancer and Sun Knowledge Scale will increase. The skin cancer sun knowledge scale measures parents' knowledge of sun health. A high score on the scale indicates a high level of knowledge. The training given to the training group includes skin cancer and sun protection. Therefore, as a result of the study, it is aimed to increase the knowledge of parents.
    It is aimed to increase the number of parents who apply SSE to their children.
    After the training to be given to the training group, an increase is expected in the rate of parents giving self skin examination (SSE) to their children. The training includes information about SSE. For this reason, it is aimed to increase the awareness of parents and turn it into behavior.
    An increase in the parental sun protection scale rate is expected.
    After the intervention to the training group, an increase in the parents' "Parental Sun Protection Scale" scores is expected. The content of the training to be given to the training group includes information about sun protection behaviors. It is aimed to increase the number of parents who practice sun protection behaviors in children.

    Secondary Outcome Measures

    The difference between the training group and the control group is aimed.
    No change is expected in the scale scores of the parents of the control group. It is aimed to find a statistically significant difference between the scale scores of the training group and the scale scores of the control group.

    Full Information

    First Posted
    January 21, 2022
    Last Updated
    March 30, 2023
    Sponsor
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05240209
    Brief Title
    Skin Cancer, Self Skin Examination and Sun Protection Behaviors Training
    Acronym
    RCT
    Official Title
    The Effect Of Educatıon Gıven To Parents About Skın Cancer And Skın Self-Examınatıon On Theır Chıldren's Sun Protectıon Behavıors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Introduction: Cancer is a serious disease with a high mortality rate in the world and in Turkey today. Skin cancer, which is among the most common types of cancer, is increasing every year in many countries in the world such as Australia, America, New Zealand, and in Turkey. The most dangerous type of skin cancer with a high mortality risk is melanoma. According to the Turkish Cancer Statistics, melanoma is among the ten most common cancer types among children aged 0-14 years. This situation constitutes a public health problem. Aim: This research was planned to determine the effect of education given to parents of secondary school students about skin cancer, Skin Self Examination (SSE) and Sun Protection Behaviors on their children's sun protection behaviors.
    Detailed Description
    Hypotheses: H0-1: There is no difference between the education and control groups in the education given to parents about skin cancer and SSE, about skin cancer sun knowledge. H1-1: There is a difference between the education given to parents about skin cancer and SSE, and the intervention and control groups about skin cancer sun knowledge. H0-2: There is no difference between the education group and the control group in terms of the education given to parents about skin cancer and SSE and their children's sun protection behaviors. H1-2: There is a difference between the education group and the control group in terms of the education given to parents about skin cancer and SSE and their children's sun protection behaviors. Design and Venture Details: The research will be conducted in a randomized controlled experimental design. The research will be carried out between February 2022 and June 2022. The sample of the study will consist of 300 parents, 150 of whom are in the intervention group (education group) and 150 in the control group, who have students studying in two different public schools in Turkey and agree to participate in the research. In order not to affect the groups from the applications, the schools were first randomized. Research data will be collected by the researcher in two stages as pre-test and post-test, using the Socio-demographic Form, the Descriptive Information Form, the Skin Cancer and Sun Knowledge Scale (SCSKS) and the Parental Sun Protection Scales (PSPS). After collecting the pre-test data from the intervention group and control group, training will be given to the intervention group with a PowerPoint presentation on What is Skin Cancer, SSE and Sun Protection Behaviors. brochure material will be distributed. The trainings are planned to be approximately 40-45 minutes. A follow-up period of 4 months (120 days) will be expected after the training, and no intervention will be made to the control group. At the end of the follow-up period, post-test data will be collected from both groups. An information brochure will be given to the control group in line with the principle of equality immediately after the completion of the post-tests. Participants: 1. Education (Intervention) Group: In the pre-test phase of the research; Education group parents, those who signed the Informed Voluntary Consent Form and agreed to participate in the research will fill out the questionnaire. Data collection will take approximately 20-25 minutes. Afterwards, the researcher will give training to the training group about skin cancer, skin self-examination and sun protection behaviors. The tutorials are planned as a PowerPoint demonstration. It will be divided into five groups in total, in groups of 20-25 people. The duration of the trainings is planned to take approximately 40-45 minutes. The content of the training was prepared in line with the literature review and taking the opinion of an expert (an expert in the field of Public Health Nursing). As a method; It will be in the form of narration, question and answer, brainstorming. Materials used in education; Colorful brochures on the subject will be given to reinforce the slide show and post-training information. A follow-up period of four months (120 days) will be expected after the training given. At the end of the follow-up period (120 days), the training group will have to fill out the post-test questionnaires during the post-test phase. Participants will be reminded of the purpose of the research. Approval of the Informed Consent Form will be received. Completing the post-test questionnaires will take approximately 20-25 minutes. Control Group: In the pre-test phase of the study; control group parents, those who signed the Informed Consent Form and agreed to participate in the study will fill out the questionnaire. Data collection will take approximately 20-25 minutes. During the follow-up period (120 days), no intervention will be made on the control group. At the end of the follow-up period (120 days), the control group will have to fill out the post-test questionnaires during the post-test phase. Participants will be reminded of the purpose of the research. Approval of the Informed Consent Form will be received. Completing the post-test questionnaires will take approximately 20-25 minutes. A brochure training material will be distributed to the parents of the control group, in line with the principle of equality, immediately after the completion of the post-tests. Inclusion Criteria: To agree to participate in the research, Being a parent with a child between the ages of 10-14, Being open to communication and cooperation, Being able to read and write, Randomization: In order not to affect the groups from the applications Schools were randomized. Schools hold closed-envelope lots, it is selected by the method. it is divided into intervention Group (Training Group) and control Group. Yalçın Eskiyapan Secondary School (Group I) Education Group was assigned as the Hacı Mustafa Tarman Secondary School (Group II) Control Group. Intervention and control groups in order to reduce selection bias and control the variables that may have an effect on the outcome variables; Randomized assignment was made by a statistician who did not know the student names and characteristics. In determining the students to be included in the research; student lists and Excel 2016 program were used, Simple Random Sampling was done. The student lists assigned to the groups by the expert were sent to the researcher before the initiatives started. It was planned to include one parent of each student in the study by selecting students. The researcher who evaluated the outcomes was blinded to determine the groups. Data Collection:Data of the study;Introductory information form: Sociodemographic form, Skin Cancer Risk Features, Skin Cancer and SSE Awareness Status, SSE Information Form,Skin Cancer and Sun Knowledge Scale (SCSKS),Parental Sun Protection Scales (PSPS), these scales will be used. Statistics to be made: The data obtained in the research will be evaluated with the Statistical Package for Social Sciences (SPSS Inc. Chicago, USA) version 25.0 statistical analysis program for Windows. In the evaluation of data, descriptive statistics on continuous data; mean, standard deviation, median, minimum, maximum values; For discrete data, numbers and percentages will be used. Kolmogorov Smirnov test will be used to examine the conformity of the data to the normal distribution. Chi-square test will be used to compare the descriptive characteristics of parents and their children in the intervention and control groups, and to compare the skin cancer and SSE knowledge status of the parents in the intervention and control group. Wilcoxon test will be used to compare the pretest and posttest scores of the intervention and control groups. Mann Whitney U test will be used to compare scale scores with two-group independent variables. The t-test will be used to compare the normally distributed continuous data in two groups. Chi-square and Fisher's Exact tests were planned to be used in group comparisons (cross tables) of nominal variables. p<0.05 will be accepted as the statistical significance limit. It will be interpreted that it is statistically significant for p values less than or equal to this value, and not statistically significant for larger values. Ethical Issues: Health Sciences University Gulhane in order to carry out the research Ethics committee approval numbered 2020-98 was obtained from the Non-Interventional Research Ethics Committee. In order to carry out the research in the designated schools, the necessary permission was obtained from the Ankara Governorship National Education Directorate, numbered 14588481-605.99-E.1192083. Parents who will participate in the research will receive the consent of the Informed Voluntary Consent Form explaining the purpose and subject of the research, the risks, benefits, harms and confidentiality of the research. Key Words: Nursing, Self skin examination, Skin Cancer, Sun Protection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Cancer
    Keywords
    Skin Cancer,, Nursing, skin self-examination, sun protection

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled experimental research
    Masking
    Participant
    Masking Description
    Randomization:In order not to affect the groups from the applications Schools were randomized.Schools hold closed-envelope lots,it is selected by the method.It is divided into intervention and control Group.YalçınEskiyapanSecondarySchool(Group I)Education Group was assigned as the HacıMustafaTarmanSecondarySchool(Group II)Control Group.Intervention and control groups in order to reduce selection bias and control the variables that may have an effect on the outcome variables;Randomized assignment was made by a statistician who did not know the student names and characteristics.In determining the students to be included in the research;student lists and Excel2016program were used,Simple RandomSampling was done.The student lists assigned to the groups by the expert were sent to the researcher before the initiatives started.It was planned to include one parent of each student in the study by selecting students.The researcher who evaluated the outcomes was blinded to determine the groups.
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Education (Intervention) Group
    Arm Type
    Experimental
    Arm Description
    In the pretest phase of the research;Education group, those who signed the Informed Voluntary Consent Form and agreed to participate in the research will fill out the questionnaire.Data collection will take approximately 20-25 minutes.Afterwards,the researcher will give training to the training group about skin cancer,skin self-examination and sun protection behaviors.The tutorials are planned as a PowerPoint demonstration.The duration of the trainings is planned to take approximately 40minutes.The content of the training was prepared in line with the literature review.As a method;It will be in the form of narration,question and answer,brainstorming.Materials used in education;Colorfulbrochures on the subject will be given to reinforce the slide show and post-training information.A follow-up period of four months will be expected after the training given.At the end of the follow-up period,the training group will have to fill out the post-test questionnaires during the post-test phase.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control Group: In the pre-test phase of the study; control group parents, those who signed the Informed Consent Form and agreed to participate in the study will fill out the questionnaire. Data collection will take approximately 20-25 minutes. During the follow-up period (120 days), no intervention will be made on the control group. At the end of the follow-up period (120 days), the control group will have to fill out the post-test questionnaires during the post-test phase. Participants will be reminded of the purpose of the research. Approval of the Informed Consent Form will be received. Completing the post-test questionnaires will take approximately 20-25 minutes. A brochure training material will be distributed to the parents of the control group, in line with the principle of equality, immediately after the completion of the post-tests.
    Intervention Type
    Other
    Intervention Name(s)
    The researcher will give training to the training group about skin cancer, skin self-examination and sun protection behaviors.
    Other Intervention Name(s)
    Colorful brochures
    Intervention Description
    Materials used in education; Colorful brochures on the subject will be given to reinforce the slide show and post-training information.
    Primary Outcome Measure Information:
    Title
    It is aimed to increase the Skin Cancer Sun Knowledge Scale scores of the education group.
    Description
    . After the training to be given to the training group, it is expected that the scores of the parents in the training group from the Skin Cancer and Sun Knowledge Scale will increase. The skin cancer sun knowledge scale measures parents' knowledge of sun health. A high score on the scale indicates a high level of knowledge. The training given to the training group includes skin cancer and sun protection. Therefore, as a result of the study, it is aimed to increase the knowledge of parents.
    Time Frame
    At the end of the follow-up period, up to 4 months
    Title
    It is aimed to increase the number of parents who apply SSE to their children.
    Description
    After the training to be given to the training group, an increase is expected in the rate of parents giving self skin examination (SSE) to their children. The training includes information about SSE. For this reason, it is aimed to increase the awareness of parents and turn it into behavior.
    Time Frame
    At the end of the follow-up period, up to 4 months
    Title
    An increase in the parental sun protection scale rate is expected.
    Description
    After the intervention to the training group, an increase in the parents' "Parental Sun Protection Scale" scores is expected. The content of the training to be given to the training group includes information about sun protection behaviors. It is aimed to increase the number of parents who practice sun protection behaviors in children.
    Time Frame
    At the end of the follow-up period, up to 4 months
    Secondary Outcome Measure Information:
    Title
    The difference between the training group and the control group is aimed.
    Description
    No change is expected in the scale scores of the parents of the control group. It is aimed to find a statistically significant difference between the scale scores of the training group and the scale scores of the control group.
    Time Frame
    At the end of the follow-up period, up to 4 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: To agree to participate in the research, Being a parent with a child between the ages of 10-14, Being open to communication and cooperation, Being able to read and write, Exclusion Criteria: Having a situation that may prevent written and verbal communication, Not to have a child between the ages of 10-14, Not agreeing to participate in the research, Being illiterate,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eylül Yeşilyurt Research Assistant
    Phone
    905061108000
    Email
    ky.eylul16@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ş.Zehra Altunkürek Assistant Professor, PhD, MSN
    Phone
    905422923154
    Email
    zehraaltunkurek@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eylül Yeşilyurt Research Assistant
    Organizational Affiliation
    ky.eylul16@gmail.com
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    At the end of the study, it will be given in the publication.
    IPD Sharing Time Frame
    end of study, September 2022
    IPD Sharing Access Criteria
    Publication in any journal in Pubmed.
    IPD Sharing URL
    https://pubmed.ncbi.nlm.nih.gov/
    Citations:
    PubMed Identifier
    33089943
    Citation
    Sumen A, Oncel S. The effect of 'I am Protecting my Child from the Sun' programme on parental sun protection behaviours: Randomized controlled trial. J Adv Nurs. 2021 Jan;77(1):387-400. doi: 10.1111/jan.14614. Epub 2020 Oct 22.
    Results Reference
    result
    PubMed Identifier
    33429351
    Citation
    Zehra Altunkurek S, Kaya E. Parents' knowledge and understanding of skin cancer and skin self-examination and behaviors to protect their children from the sun. Eur J Oncol Nurs. 2021 Feb;50:101884. doi: 10.1016/j.ejon.2020.101884. Epub 2020 Dec 4.
    Results Reference
    result
    PubMed Identifier
    34359770
    Citation
    Horvath Z, Evelin CA, Olah P, Gyulai R, Lengyel Z. Results of a Primary Skin-Cancer-Prevention Campaign in Early Childhood on Sun-Related Knowledge and Attitudes in Southern Hungary. Cancers (Basel). 2021 Jul 31;13(15):3873. doi: 10.3390/cancers13153873.
    Results Reference
    result
    Links:
    URL
    https://hsgm.saglik.gov.tr/tr/kanser-istatistikleri
    Description
    Turkey Cancer Statistics
    URL
    https://www.skincancer.org/
    Description
    Skin Cancer Foundation

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