Protocol summary

Summary
This study aimed to empower farmers against skin cancer. This study was an experimental intervention. Participants will be selected from farmers. The main inclusion criteria include male gender, farming in spring and summer, at least a primary literacy, lack of skin cancer in persons and their families and exclusion criteria include refusal for participation in the study. The sample size was obtained 114 persons for each group, of course considering probability of loss of patients around 10%, The sample size was 124 persons for each group. After selecting the intervention and control groups, the data will be collected in two stages: The first phase of data collection will be before the intervention and the second stage 3 months after the intervention. Data will be collected using a questionnaire of based on the protection motivation theory. In the stage before the intervention, the per-test will be done in both intervention and control groups ,and after analyzing the data, resources, limitation, needs, and strengths and weaknesses in different fields are identified , then type of content, teaching methods, time and the number of training sessions are designed based on the steps. Outcomes of the study is preventive behaviors in farmers, before and after training

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010315422N2
Registration date: 2015-01-18, 1393/10/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Towhid Babazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
t-babazadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on protection motivation theory on farmers empowerment for skin cancer preventive behaviors
Public title
The effect of education on prevention of high risk behaviors of skin cancer in farmers
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: male; farming in spring and summer seasons; subjects with elementary graduate; lack of skin cancer in participants and their family Exclusion criteria: Migration of Chalderan county period of the study; The died person time interval of the study; uninteresting to participate in the study
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 248
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
Tabriz University of Medical Sciences
Street address
Ethics Committee, Third Floor, Central Building 2, Tabriz University of Medical Science, Golgashte, Tabriz
City
Tabriz
Postal code
Approval date
2014-11-24, 1393/09/03
Ethics committee reference number
93128

Health conditions studied

1

Description of health condition studied
Skin Cancer
ICD-10 code
C44.6
ICD-10 code description
Skin Cancer

Primary outcomes

1

Description
Risky behaviors
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Perceived susceptibility toward skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

2

Description
Perceived severity of toward skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

3

Description
The perceived rewards toward skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

4

Description
Self-efficacy toward skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

5

Description
Response efficacy toward skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

6

Description
Response cost toward skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

7

Description
Protection motivation against to skin cancer
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
The Intervention group: In this study the intervention will be holding the training sessions. The intervention would be based on information obtained from the questionnaire.
Category
Behavior

2

Description
The control group: Training in groups is not but after the end of data collection in the end of study, educational pamphlets and pamphlets will be given to the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Chaldran Health Network
Full name of responsible person
Towhid Babazadeh
Street address
Chaldran Health Network, City Chaldoran, West Azerbaijan province
City
Chaldoran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Deputy for Research and Technology, Third Floor, Central Building 2, Tabriz University of Medical Sciences, Golgasht, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
towhid.babazadeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
towhid.babazadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
towhid.babazadeh@gmail.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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