NCT06238453

Brief Summary

It is known that the healing process of breast cancer is accelerated thanks to the early diagnosis and effective treatment. Mammography screening is an important diagnostic method in the early diagnosis of breast cancer. It is thought that the education to be given according to the Health Belief Model will make important contributions to developing a positive attitude in breast cancer screenings and regular mammography.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

December 29, 2023

Last Update Submit

February 1, 2024

Conditions

Keywords

Breast CancerHealth Belief ModelMammography

Outcome Measures

Primary Outcomes (2)

  • Pre-test evaluation

    The Health Belief Model Scale for Breast Cancer Screening and the Mammography Self-Efficacy Scale will be administered to all women in the experimental and control groups for pre-test purposes. There is no overall total score of the Health Belief Model Scale on Breast Cancer Screenings. Each sub-dimension's own total score is evaluated. The scale is a Likert type scale scored from 1 to 5. The scoring of the scale ranges from 1 point for "strongly disagree" to 5 points for "strongly agree". Increasing scores obtained from sub-dimensions indicate that the perception of that sub-dimension is high. Mammography Self-Efficacy Scale has ten items and five-point Likert type. The scale answers "strongly disagree" are evaluated as 1 point, "disagree" as 2 points, "undecided" as 3 points, "agree" as 4 points and "strongly agree" as 5 points. A higher score for each dimension indicates a higher probability of having a mammogram.

    Three month

  • Posttest evaluation

    Training presentations will be sent to the experimental group in the first 6 weeks and training videos will be sent in the last 2 weeks. A total of 8 weeks of intervention will be implemented. Training content will be sent via WhatsApp application once a week. No intervention will be made to the control group by the researchers during this period. Those in the control group will be invited to KETEM to have a mammogram. Three months after the training is completed, the Health Belief Model Scale for Breast Cancer Screening and the Mammography Self-Efficacy Scale will be administered to both groups for posttest purposes.

    Six month

Study Arms (2)

Experimental group

Educational content will be sent to the experimental group once a week via the WhatsApp application, and individual counseling will be provided by answering their questions at the same time. A total of 8 weeks of intervention will be implemented, training will be given with training presentations in the first 6 weeks and training videos will be sent in the last 2 weeks.

Control group

The control group will be invited to KETEM to have a mammogram without any intervention.

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population of the study will consist of women who have applied to Erzurum Cancer Early Diagnosis, Screening and Training Center before, had mammography and phone records, whose appointment has been made since December 2022, and who meet the sampling selection criteria.

You may qualify if:

  • Be between the ages of 40-69,
  • Be woman,
  • Not having been diagnosed with breast cancer,
  • Not to be pregnant, lactating or puerperal,
  • Absence of a mental illness
  • At least 2 years have passed since the last mammogram,
  • Being able to use the WhatsApp application

You may not qualify if:

  • Having had problems with breast cancer before,
  • Having a mammogram at regular intervals,
  • Having had breast-conserving surgery for any purpose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Academician (Lecturer)

Study Record Dates

First Submitted

December 29, 2023

First Posted

February 2, 2024

Study Start

February 12, 2024

Primary Completion

April 2, 2024

Study Completion

August 10, 2024

Last Updated

February 2, 2024

Record last verified: 2024-02