NCT05418985

Brief Summary

A randomized control trial was made to examine the effects of of monthly text message reminder after training on beliefs and practice behaviors regarding women's breast self examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

June 10, 2022

Last Update Submit

September 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Women's beliefs about breast self-exam levet (mean ± SD)

    The primary outcome of this study was the mean beliefs about breast self-exam levet (mean ± SD) of the womens at 3 months after BSE education. Women beliefs about breast self-exam level was assessed using Champion's Health Belief Model Scale.

    3 months after BSE education

Secondary Outcomes (1)

  • Behaviors of women performing breast self-examination

    3 months after BSE education

Study Arms (2)

Intervention group

EXPERIMENTAL

Women in this group were given training on breast self-examination (BSE). In the three-month period following the training, a reminder text message was sent to mobile phones by the researcher to perform BSE. The text message was sent to women with regular and regular menstrual cycles on the seventh day after the bleeding ceased, and on the first day of the month to menopausal women with irregular menstrual cycles.

Behavioral: Monthly reminder message about breast self-exam.

Control droup

NO INTERVENTION

Women in this group were given training on breast self-examination (BSE). No intervention was made afterwards.

Interventions

Monthly reminder message about breast self-exam.

Intervention group

Eligibility Criteria

Age20 Years - 69 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 20-69,
  • Able to speak and understand Turkish,
  • At least primary school graduate,
  • Not in pregnancy or postpartum period,
  • Not in the breastfeeding process,
  • Menarche,
  • No current diagnosis of breast cancer,
  • No breast disease that may affect the examination finding.

You may not qualify if:

  • Those who did not complete the training on BSE,
  • Those who want to leave the research,
  • Those who had pregnancy during the research and
  • Those who do not fill in the data forms sent to their e-mail addresses despite being reminded by message three times.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey, 4600, Turkey (Türkiye)

Location

Study Officials

  • Hilal ALKAN, Student

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

September 1, 2021

Primary Completion

December 15, 2021

Study Completion

July 30, 2022

Last Updated

September 27, 2024

Record last verified: 2021-09

Locations