Examination of the Effect of Counselling and Follow-up After Breast Cancer Awareness Training

Sponsor
Tarsus University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06005025
Collaborator
Mersin University (Other)
160
1
2
11
14.5

Study Details

Study Description

Brief Summary

The aim of the study was to examine the effect of counselling and follow-up after education on the risks and prevention methods of breast cancer on early diagnosis behaviours and healthy lifestyle behaviours. The population of the study will consist of female administrative staff working at Mersin University. The sample of the study will consist of 160 people. A total of 160 personnel determined by randomisation will be divided into group A (study) and group B (control) formed by the independent researcher in the computer environment. All participants will be given a one-hour training on breast cancer and will be practised with a model as well as a presentation. Group A will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received. In group B, no additional application will be made except for the training. The data of the study will be collected before and 6 months after the training by using the Descriptive Characteristics Form, Breast Cancer Early Diagnosis Behaviours Form, Counselling Form and Healthy Lifestyle Behaviours Scale II. The data obtained from the study will be analysed in a computer environment. Number, percentage, mean and standard deviation will be used as descriptive statistics in the evaluation of the data.

Condition or Disease Intervention/Treatment Phase
  • Other: Reminder message
N/A

Detailed Description

The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study. The aim of the study was to examine the effect of counselling and follow-up after education on the risks and prevention methods of breast cancer on early diagnosis behaviours and healthy lifestyle behaviours. The population of the study will consist of female administrative staff working at Mersin University. The sample of the study will consist of 160 people with an effect size of 0.23, 80% power maximum 5% type 1 error and drop out rate of 10%. The sample determined by randomisation A total of 160 personnel in the group will be divided into group A (study) and group B (control) formed by the independent researcher in the computer environment. All participants will be given one-hour training on breast cancer, modifiable and non-modifiable risk factors for breast cancer, symptoms of breast cancer, screening programmes and breast self-examination. Group A will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your Changeable Risk Factors for Breast Cancer" and their feedback will be received. In group B, no additional application will be made except for the training. The data of the study will be collected before and 6 months after the training by using the Descriptive Characteristics Form, Breast Cancer Early Diagnosis Behaviours Form, Counselling Form and Healthy Lifestyle Behaviours Scale II. The data obtained from the study will be analysed in a computer environment. Number, percentage, mean and standard deviation will be used as descriptive statistics in the evaluation of the data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study.The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Firstly, the names of the personnel will be listed alphabetically. A number will be written opposite each personnel and the number of 160 personnel will be determined from the total number of administrative personnel with high risk level by randomisation generated by an independent researcher in the computer environment. The sequence number of the personnel determined by randomisation will be divided into group A (study) and group B (control) in the computer environment and the information showing that they are assigned to group A and B according to the randomisation table will be placed in an opaque envelope. This envelope will be kept by the coordinator researcher and when the staff is approached for training, it will be learnt which group the staff is in. Since all personnel will be trained, the personnel will be blinded. The data will be computerised by the researcher and a biostatistician independent of the research will blind the groups unknowingly
Primary Purpose:
Supportive Care
Official Title:
The Effect of Counselling and Follow-up After Breast Cancer Awareness Training on Early Diagnosis and Healthy Lifestyle Behaviours: 'Reduce Risks, Increase Life Chances'
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: REMİNDER MESSAGE

All participants will be given one-hour training on breast cancer, modifiable and non-modifiable risk factors for breast cancer, symptoms of breast cancer, screening programmes and breast self-examination. In addition to the presentation, breast self-examination will be applied one-to-one with a breast examination model. This group will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received.

Other: Reminder message
Experimental group will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received.

No Intervention: CONTROL GROUP

All participants will be given one-hour training on breast cancer, modifiable and non-modifiable risk factors for breast cancer, symptoms of breast cancer, screening programmes and breast self-examination. In addition to the presentation, breast self-examination will be applied one-to-one with a breast examination model. There will be no additional practice outside the training.

Outcome Measures

Primary Outcome Measures

  1. Behaviours for Early Diagnosis of Breast Cancer [6 months]

    Breast Cancer Early Diagnosis Behaviours Form: It is a form consisting of 5 questions about the frequency of early diagnosis behaviours such as breast self-examination, clinical breast examination and mammography.

  2. Counselling [6 months]

    Counselling Form: This is a 5-question form that includes information on the subject consulted, the number of consultations, what was recommended in the consultation, the status of referral to a health institution after the consultation and what the outcome was if referred to a health institution.

  3. Healthy Lifestyle Behaviours [6 months]

    Healthy Lifestyle Behaviours Scale II; The scale consists of six subscales under the titles of 'health responsibility', 'physical activity', 'nutrition', 'spiritual development', 'interpersonal relationships' and 'stress management'. The higher score obtained from the scale indicates more appropriate lifestyle behaviour.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 35 years and older,

  • No visual impairment and no physical problems that would prevent breast self-examination,

  • Not previously diagnosed with breast cancer,

  • Accepted to participate in the research,

  • Female administrative staff working at Mersin University

Exclusion Criteria:
  • 35 and under,

  • Visually impaired and have a physical problem that would prevent them from performing breast self-examination,

  • Previously diagnosed with breast cancer,

  • Willing did not agree to participate in the research,

  • Female administrative staff not working at Mersin University

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gamze Bozkul Mersin Turkey 33400

Sponsors and Collaborators

  • Tarsus University
  • Mersin University

Investigators

  • Principal Investigator: Seher Gürdil Yılmaz, Lecturer Dr., Mersin University
  • Principal Investigator: Gamze Bozkul, Res. Ass, Tarsus University
  • Study Director: Gülay Altun Uğraş, Assoc.Dr., Mersin University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gamze BOZKUL, Principal Investigator (Research Assistant), Tarsus University
ClinicalTrials.gov Identifier:
NCT06005025
Other Study ID Numbers:
  • TU-BOZKUL-003
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023