Protocol summary

Summary
This quasi-experimental intervention study with pretest/post test was conducted to determine the effects of self-care education on performing breast self-exam (BSE) among women referred to health centers. 168 women were entered in the study. Inclusion criteria ; referring to health centers in Nurabad Mamasani; being at most 50 years old for married women and more than 25 years old for single ones; did not have breast cancer; continuous participation in the educational program. Exclusion criteria; being diagnosed with breast cancer based on self-reporting and medical records; being pregnant; breast-feeding. These women were non- randomly divided into intervention and control group. We had not blinding in the study. Main outcome in this study was self-care behavior that was measured by validated researcher-made questionnaire. Inclusion criteria ; referring to health centers in Nurabad Mamasani; being at most 50 years old for married women and more than 25 years old for single ones; did not have breast cancer; continuous participation in the educational program. Exclusion criteria; being diagnosed with breast cancer based on self-reporting and medical records; being pregnant; breast-feeding. The instruments were administered to both groups before intervention and after holding training classes for intervention group; one week and 10 weeks after the intervention the questionnaire were administered to both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012115015N16
Registration date: 2017-04-25, 1396/02/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-25, 1396/02/05
Registrant information
Name
Leila Ghahremani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ghahramanl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of self-care education program's effect on breast self-examination behaviors in women attending to health care centers
Public title
Self-care education programs effect on breast self-examination behaviors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria ; referring to health centers in Nurabad Mamasani; being at most 50 years old for married women and more than 25 years old for single ones; did not have breast cancer; continuous participation in the educational program. Exclusion criteria; being diagnosed with breast cancer based on self-reporting and medical records; being pregnant; breast-feeding.
Age
From 25 years old to 100 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Shiraz University of Medical Sciences
Street address
Shiraz University Of Medical Sience, Namazi Square
City
Shiraz
Postal code
Approval date
2014-04-21, 1393/02/01
Ethics committee reference number
7259-93

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Self-care bihavior in prevention of breast cancer
Timepoint
Before intervantion , one week after intervention, ten weeks after intervention
Method of measurement
Questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, the training program was self-care education on breast cancer. Training program was performed in four weekly 45-minute sessions. In each session lecture delivery and question-answer methods were used to educate participants. The education program included theoretical and practical training material which delivered through direct teaching methods, such as giving lecture, question and answer, breast self-exam (BSE) training videos, slideshows, and flip charts. At the end of the training sessions, educational pamphlets were also distributed among the participants of the intervention group. The questionnaire was administered to the women in both groups one week and 10 weeks after the intervention.
Category
Prevention

2

Description
Control group: without any intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center city Nurabad Mamasani
Full name of responsible person
Miss.Zakiye Mosavi
Street address
Nourabad, Nurabad Mamasani Health Center
City
Nurabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sience
Full name of responsible person
ِDr. Leila Ghahramani
Street address
School of health, Koye Zahra, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz University of Medical Sience
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Leila Ghahramani
Position
Professor
Other areas of specialty/work
Street address
School of health, Koye Zahra, Shiraz
City
Shiraz
Postal code
Phone
+98 930 244 6689
Fax
Email
mousavi_za@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Leila Ghahramani
Position
Professor
Other areas of specialty/work
Street address
School of health, Koye Zahra, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1005
Fax
Email
mousavi_za@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Leila Ghahramani
Position
Professor
Other areas of specialty/work
Street address
School of health, Koye Zahra, Shiraz
City
Shiraz
Postal code
00987137251005
Phone
+98 71 3725 1005
Fax
Email
mousavi_za@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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