Protocol summary

Summary
The Effect of Education Based on the Theory of Planned Behavior on Promote Health Literacy and Breast Cancer Screening Among Rural Women Referred to Health Care Centers In Roshtkar Abstract Introduction: Breast cancer is the most common cancer and the second leading cause of cancer death among Iranian women. This study aimed to determine The Effect of Education Based on the Theory of Planned Behavior on health literacy and Breast Cancer Screening Tests performance in women referred to health care centers Methods: In this semi-experimental study 80 women above age 35 years were selected by Multi-stage random sampling and randomly divided into either experimental or control groups. Data were collected by researcher-made questionnaire included questions about demographics, knowledge, attitudes, subjective norms, perceived behavioral control, intention, behavior and questionnaire of Test of functional health literacy in adults and Realm. The questionnaires were completed by women during the three periods: before, immediately after and three month after the intervention. Data were analysed using Spss software Version 16, using descriptive statistics and Spearman correlation test, Kruskal-Wallis , Paired t-test , Independent t-tests, Mann-Whitney, linear regression , General linear model and Repeated Measures ANOVA (α=0.05).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071028863N1
Registration date: 2017-02-21, 1395/12/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-21, 1395/12/03
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education Based on the Theory of Planned Behavior on Promote Health Literacy and Breast Cancer Screening Among Rural Women Referred to Health Care Centers in Roshtkhar
Public title
The Effect of Education Based on the Theory of Planned Behavior on Promote Health Literacy and Breast Cancer Screening
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria ؛ Person’s intention to participate in the study؛ Iranian؛ Age 35 years and older؛ Lack of breast cancer؛ Exclusion criteria؛ Every Woman with any kind of malignancy OR Breast cancer؛ The Absence of two or more of the class sessions
Age
From 35 years old to 75 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
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
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Health, Daneshgah18 Street, Danshgah Avenue, Mashhad
City
Mashhad
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.mums.ac.rec.1394.131

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C 50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Breast cancer screening
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire and check list

2

Description
Clinical examination
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

3

Description
Mamography
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

4

Description
Health Literacy
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Attitude
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

2

Description
subjective norm
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

3

Description
Behavicral intention
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

4

Description
perceived behavioral control
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

5

Description
Behavior
Timepoint
Before The intervention, One Month and three months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
In intervention group, Education based on The theory of planned behavior was performed with 4 sessions of 60 minutes
Category
Early detection

2

Description
In control group we do not give them the instructions in intervention group , however if they want will be guide to health care providers to be educated .Then they will be followed up 3 months later.
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Roshtkhar
Full name of responsible person
Nooshin Peyman
Street address
Health center of Roshtkhar, Roshtkhar , Khorasan Razavi
City
Roshtkhar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Medical Sciences Headquarters, University avenue
City
Mashhad
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, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Amani
Position
Masters of Health Education and Health Promotion
Other areas of specialty/work
Street address
School of Health, Daneshgah18 Street, Danshgah Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 915 532 0755
Fax
Email
amanim1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Position
PhD in Health Education building community health
Other areas of specialty/work
Street address
School of Health, Daneshgah18 Street, Danshgah Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3854 4633
Fax
Email
peymann@mums.ac.ir
Web page address

Person responsible for updating data

Contact

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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