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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05240209
Recruitment Status : Not yet recruiting
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Eylul Yesilyurt, Saglik Bilimleri Universitesi

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.


Condition or disease Intervention/treatment Phase
Skin Cancer Other: The researcher will give training to the training group about skin cancer, skin self-examination and sun protection behaviors. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled experimental research
Masking: Single (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.
Primary Purpose: Basic Science
Official Title: The Effect Of Educatıon Gıven To Parents About Skın Cancer And Skın Self-Examınatıon On Theır Chıldren's Sun Protectıon Behavıors
Estimated Study Start Date : February 7, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Education (Intervention) Group
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.
Other: The researcher will give training to the training group about skin cancer, skin self-examination and sun protection behaviors.
Materials used in education; Colorful brochures on the subject will be given to reinforce the slide show and post-training information.
Other Name: Colorful brochures

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. It is aimed to increase the Skin Cancer Sun Knowledge Scale scores of the education group. [ Time Frame: At the end of the follow-up period, up to 4 months ]
    . 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.

  2. It is aimed to increase the number of parents who apply SSE to their children. [ Time Frame: At the end of the follow-up period, up to 4 months ]
    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.

  3. An increase in the parental sun protection scale rate is expected. [ Time Frame: At the end of the follow-up period, up to 4 months ]
    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 :
  1. The difference between the training group and the control group is aimed. [ Time Frame: At the end of the follow-up period, up to 4 months ]

    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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,

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): NCT05240209


Contacts
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Contact: Eylül Yeşilyurt Research Assistant 905061108000 ky.eylul16@gmail.com
Contact: Ş.Zehra Altunkürek Assistant Professor, PhD, MSN 905422923154 zehraaltunkurek@gmail.com

Sponsors and Collaborators
Saglik Bilimleri Universitesi
Investigators
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Principal Investigator: Eylül Yeşilyurt Research Assistant ky.eylul16@gmail.com
Additional Information:
Publications of Results:
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Responsible Party: Eylul Yesilyurt, research assistant, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT05240209    
Other Study ID Numbers: SaglikBilimleriU-001
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the end of the study, it will be given in the publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: end of study, September 2022
Access Criteria: Publication in any journal in Pubmed.
URL: https://pubmed.ncbi.nlm.nih.gov/

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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 Eylul Yesilyurt, Saglik Bilimleri Universitesi:
Skin Cancer,
Nursing
skin self-examination
sun protection
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases