Protocol summary

Summary
This study aimed at examining the effectiveness of breast cancer screening education based on systematic health education and promotion model (SHEP) to health volunteers on the knowledge, attitude and performance of women who attended to health care centers in Mashhad. Design: This was an interventional study with a pretest-posttest control group design.Procedure: Using a systematic random sampling 12 health volunteers and 120 women who had referred to health care centers in Mashhad were selected and were randomly assigned to control and case groups. The study was conducted in two phases. In the first phase, the health volunteers in the case group were trained on breast cancer screening based on the model for two four-hour sessions. The control group received the usual training program. Then in each health care center, 10 women were assigned to each health volunteer. Each volunteer held a 2 hour training session for her participants. Inclusion criteria for health volunteers were: a minimum age of 20 years at the baseline, having at least a high school level of education, and consent to participate in the study. Inclusion criteria for women referring to health care centers were: minimum age of 20 years at the baseline, willingness to participate in the study, and reading and writing literacy. Exclusion criteria were: discontented to continue the study, and presence of less than 30 minutes in the training session. Intervention: the intervention in this study was training intervention using SHEP model. Main outcome variables also included knowledge, attitude and performance.

General information

Acronym
SHEP
IRCT registration information
IRCT registration number: IRCT2016050427746N1
Registration date: 2016-07-02, 1395/04/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Shadan Nessari Ashkezari
Name of organization / entity
Mashhad University Medical of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 0542
Email address
nesarish921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-18, 1394/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating effects of breast cancer screening education based on Systematic comprehensive Health Education and Promotion model to health volunteers on women's knowledge, attitude and practice
Public title
Breast cancer screening education
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for health volunteers were: a minimum age of 20 years at the baseline, having at least a high school level of education, and consent to participate in the study. Inclusion criteria for women referring to health care centers were: minimum age of 20 years at the baseline؛ willingness to participate in the study؛ and reading and writing literacy. Exclusion criteria were: discontent to continue participation in the study؛ and the presence of less than 30 minutes in the training session.
Age
From 74 years old to 15 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sceinces
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd., Mashhad, Iran
City
Mashhad
Postal code
9177899191
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.MUMS.REC.1394.335

Health conditions studied

1

Description of health condition studied
Knowledge, attitude and performance about breast cancer screening
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Knowledge
Timepoint
Before intervention; Immediately after intervention; One month after intervention
Method of measurement
Knowledge evaluating questionnaire

2

Description
Attitude
Timepoint
Before intervention; Immediately after intervention; One month after intervention
Method of measurement
Attitude evaluating questionnaire

3

Description
Practice
Timepoint
Before intervention; Immediately after intervention; One month after intervention
Method of measurement
Intend to do mammography and breast clinical examination questionnaire and a breast self examination checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1:An 8-hours breast cancer screening workshop conformity SHEP model was conducted over 2 days for health volunteers in experimental group.
Category
Other

2

Description
Control group1: Health volunteers in control group had their routine educational program.
Category
Other

3

Description
Intervention group 2: A 2-hours breast cancer screening educational section based on SHEP model was performed for women in experimental group by health volunteers in experimental group.
Category
Other

4

Description
Control group2: A 2-hours breast cancer screening educational section was performed based on Health centers routine education for women in control group by health volunteers in control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Abo-bargh Health center
Full name of responsible person
Dr. Hassan Ashrafi
Street address
In the end of Vila st, Shahid Fakouri Blvd
City
Mashhad

2

Recruitment center
Name of recruitment center
Shahid Najafi Health center
Full name of responsible person
Dr. Nahid Gazzani
Street address
Haghshenas St, Fakour 74 St , Shahid Fakouri Blvd
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Administration Center (Qoreishi Building), Daneshgah Street, Mashhad, Iran
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 of 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
Nursing and Midwifery school
Full name of responsible person
Khadigeh Mirzaiinajmabadi
Position
Reproductive health (PhD)/ Associated professor of midwifery department
Other areas of specialty/work
Street address
Midwifery department of nursing and midwifery school
City
Mashhad
Postal code
Phone
+98 51 3852 8512
Fax
Email
mirzaiikh@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
Shadan Nessari Ashkezari
Position
Master student of midwifery
Other areas of specialty/work
Street address
No 54, Laleh 10 St, Shahid Fakouri 17 Ave, Haft-e Tir Blvd
City
Mashhad
Postal code
9178183814
Phone
+98 51 3867 0542
Fax
Email
nesarish921@mums.ac.ir; shadan.nessari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shadan Nessari Ashkezari
Position
Master student of Midwifery
Other areas of specialty/work
Street address
N0 54, Laleh 10 St, Shahid Fakouri 17 Ave, Haft-e Tir Blvd
City
Mashhad
Postal code
9178183814
Phone
+98 51 3867 0542
Fax
Email
nesarish921@mums.ac.ir; shadan.nessari@yahoo.com
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
Loading...