Protocol summary

Study aim
Determining the Effect of Community Based Interventions on Prostate Cancer Screening in the Elderly Based on Health Belief Model.
Design
First, list the selected centers as a list, and then try to present them with a self-presentation and purpose of research by providing pamphlets, brochures, slides and educational videos on people with prostate cancer. Will help older people understand the depth of this risk and the seriousness of its various physical, psychological, social and economic consequences
Settings and conduct
The statistical population includes all elderly men over 60-75 years old who have health files in Malaier comprehensive health service centers in 2020.
Participants/Inclusion and exclusion criteria
Men between 60-75 years old, who were willing to participate in research, being elderly, married, having the ability to answer questions, not having prostate cancer, not having advanced and malignant disease, having low literacy, Full independence in care
Intervention groups
Elderly 60-75 year olds living in Malaier city with health records in comprehensive health centers
Main outcome variables
Prostate cancer screening behaviors in the elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180721040540N3
Registration date: 2020-03-27, 1399/01/08
Registration timing: prospective

Last update: 2020-03-27, 1399/01/08
Update count: 0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
Heshmatolah Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0160
Email address
heidari.h@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-07-04, 1399/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of community-based interventions on screening for prostate cancer based on health belief model
Public title
The effect of community-based interventions on screening for prostate cancer based on health belief model
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Male Willing to participate in the study Physical healthy Orientation Literacy for reading and writing Independence for self care Married Age: 60-75 years old
Exclusion criteria:
Recent history for advanced and malignant disease Taking psychotropic drugs Drug use
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 250
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling was convenience method. Eligible subjects with using the Permuted block randomization will have located in the intervention or control groups. The age (60-69 and 70-75), and level of education of subjects, will consider as stratified in the inside of blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Samples will be randomly divided into intervention and control groups, and will be unaware of their groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Research Deputy Lorestan University of Medical Sciences, Kilometrs 4 Khoramabad- Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
381251698
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.LUMS.REC.1398.260

Health conditions studied

1

Description of health condition studied
Prostate Cancer
ICD-10 code
C60
ICD-10 code description
Postprocedural (acute) (chronic) kidney failure

Primary outcomes

1

Description
Screening for prostate cancer
Timepoint
َApr to joule 2020
Method of measurement
Questionnaire

2

Description
Increased Prostate Cancer Screening Behaviors
Timepoint
Before and after
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention in this study will be based, of the health belief model constructs including, perceived sensitivity, perceived benefits and perceived barriers. The researcher, after attending the home of subjects, will teach information based the level of knowledge and understanding of the elderly and their family. The education will be held by lecture, answer and question methods and use of brochures, photos and videos.
Category
Early detection

2

Description
Control group: the control group will receive routine services of comprehensive health centers.ve health centers
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Health network of Malayer city
Full name of responsible person
Heshmatolah Heydari
Street address
No. 5/128, Ahmadi branch., Vali Bakhshi Street
City
Malayer
Province
Hamadan
Postal code
6571986133
Phone
+98 81 3334 3621
Email
Masoodahmadvand.nurse63@gmail.com
Web page address
http://malayer.umsha.ac.ir/index.aspx?fkeyid=&siteid=27&pageid=721

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Fallahi
Street address
Khorramaba- Broujerd road., Kilometers 4., Kamalvand., Deputy of research and technology., Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
381251698
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
research@lums.ac.ir
Web page address
http://research.lums.ac.ir/
Grant name
Deputy of research and technology., Lorestan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatolah Heydari
Position
Assistant Professor University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad Complex Campus of Medical Sciences, Near Payam Noor University, After Police station, Boroujerd road to Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6571986133
Phone
+98 81 3334 3621
Email
Hidari74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Heshmatolah Heydari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad Complex Campus of Medical Sciences, Near Payam Noor University, After Police station, Boroujerd road to Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6571986133
Phone
+98 81 3334 3621
Email
Hidari74@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Masoud Ahmadvand
Position
Nurs
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khorramabad Complex Campus of Medical Sciences, Near Payam Noor University, After Police station, Boroujerd road to Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6571944919
Phone
+98 81 3334 3621
Email
masoodahmadvand.nurse63@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Screening for prostate cancer
When the data will become available and for how long
6 months after doing the research
To whom data/document is available
Medical science researchers and medical students researchers
Under which criteria data/document could be used
Conducting research to improve the health of the elderly
From where data/document is obtainable
Library of Nursing Faculty of Lorestan University of Medical Sciences Nursing
What processes are involved for a request to access data/document
Contact the Researcher by Email and After Coordination, Visit the Library of Nursing School of Lorestan University of Medical Sciences and Download
Comments
Loading...