Protocol summary

Summary
We aimed to investigate the effects of health belief model (HBM)-based training on prostate cancer screening behaviors. Inclusion criteria : no history of prostate cancer and benign prostatic hyperplasia; age of 50 to70 . exclusion criteria : absence in training sessions ; participation in similar training courses.In this non-blinded randomized controlled clinical trial, we enrolled 210 men aged 50-70 during fall to winter 2013. We selected our participants from the population of men, who were retired from Shiraz Department of Education.Balanced block randomization method was used to randomize the final participants, who had inclusion criteria into case (n=93) and control (n=87) groups. they attended training workshops consisted of two four-hour sessions for two days, in groups of 15 participants based on HBM and with respect to belief and awareness need assessment.During the sessions, they were trained about the anatomy and function of prostate, risk factors, symptoms and complications of prostate cancer and methods of prostate cancer screening as well as its benefits and disadvantages. The researcher used educational methods such as lecture, group discussion, question and answer session, educational movies and booklets.Control group did not receive training. Data were collected by interviewing the participants using three questionnaires included BMH and the Knowledge about Prostate Cancer Screening questionnaires as well as demographic questionnaire at before and one month after intervention. For the assessment of prostate cancer screening, All of the men in the intervention group gived free referral form for consultation with a urologist and prostate cancer screening .

General information

Acronym
Prostate Cancer Screening
IRCT registration information
IRCT registration number: IRCT2013090911691N3
Registration date: 2014-04-09, 1393/01/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-09, 1393/01/20
Registrant information
Name
Fariba Ghodsbin Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
ghodsbin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-10-03, 1392/07/11
Expected recruitment end date
2013-12-05, 1392/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Health Belief Model-Based Training on Prostate Cancer Screening Behaviors among the Retired Clerks of Shiraz Department of Education in 2013; A randomized Controlled Clinical Trial
Public title
The Effect of Health Belief Model-Based Training on Prostate Cancer Screening Behaviors among the Retired Clerks of Shiraz Department of Education in 2013; A randomized Controlled Clinical Trial
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria :willingness to participate in the study; completing written informed consent;no history of prostate cancer and benign prostatic hyperplasia; age of 50 to70 and lack of severe vision and hearing impairment. exclusion criteria : absence in training sessions ; participation in similar training courses.
Age
From 55 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 210
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
Medical Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Bld.Vice chancellor of Shiraz university of medical sciences
City
Shiraz
Postal code
Approval date
2013-09-02, 1392/06/11
Ethics committee reference number
ct-92-6721

Health conditions studied

1

Description of health condition studied
Prostate cancer
ICD-10 code
c61
ICD-10 code description
Malignant neoplasm of prostate

Primary outcomes

1

Description
Knowledge
Timepoint
One month after the intervention
Method of measurement
Prostate Cancer Screening Knowledge Questionnaire

Secondary outcomes

1

Description
Health Belief Model component
Timepoint
One month after the intervention
Method of measurement
HBM questionnaire screening for prostate cancer

2

Description
Screening behavior
Timepoint
One and three months after intervention
Method of measurement
Participation in free screening programs

Intervention groups

1

Description
During the sessions, they Will be trained about the anatomy and function of prostate, risk factors, symptoms and complications of prostate cancer and methods of prostate cancer screening as well as its benefits and disadvantages they will attend training workshops consisted of two four-hour sessions for two days, in groups of 15 participants based on HBM and with respect to belief and awareness need assessment.All the participants in the case group Will receive referral forms for free consultation with an urologist and prostate cancer screening And then a month and three-month follow-up for the free screening program .
Category
Early detection

2

Description
Control group no intervention
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz general department of retirement
Full name of responsible person
Maryam zare
Street address
Parseh square,Pasargad Blvd,Paeeze street,1salamat complex,6th floor,unit 24
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Shiraz University of Medical Sciense
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Zand Bld, 7th Floor Research Deputy of Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shiraz University of Medical Sciense
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
Fariba Ghodsbin
Position
Ms Nursing
Other areas of specialty/work
Street address
Namazi Square,School of Nursing & Midwifery
City
Shiraz
Postal code
Phone
+98 71 1647 4251
Fax
+98 71 1647 4252
Email
Ghodsbin @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
Fariba Ghodsbin
Position
MSc in Nursing
Other areas of specialty/work
Street address
Namazi Square,School of Nursing & Midwifery
City
Shiraz
Postal code
Phone
+98 71 1647 4251
Fax
+98 71 1647 4252
Email
Ghodsbin @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
Maryam zare
Position
MSc in Nursing
Other areas of specialty/work
Street address
Parseh square,Pasargad Blvd,Paeeze street,1salamat complex,6th floor,unit 24
City
Shiraz
Postal code
7177951168
Phone
Fax
Email
Maryam_zare63@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
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