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evaluation of educational programs based on extended parallel process model (EPPM) in the field of esophageal cancer prevention behaviors among esophageal cancer patients' first-degree relatives with mix method

Protocol summary

Study aim
Determination of the effect of educational program on the perceived sensitivity, perceived severity, and self-efficacy of preventive behaviors in the field of self-care of esophageal cancer.
Design
The study , the relatives of patients with esophageal cancer using the random sampling method will be in two groups.only the intervention group will have an educational program, but in the control group there will be no intervention-based education. Finally, after 2 months of intervention, post-test is done in two groups.
Settings and conduct
In order to facilitate finding a patient, a study will be done in health centers and chemotherapy centers of hospitals in Golestan province. The study will be conducted with a descriptive phase to examine the target group's behaviors. Then the designed educational content will be available to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Involvement of a family member in esophageal cancer and being alive or Has died at least 2 years ago, First-degree relatives of cancer patients (father, mother, sister, brother, children), Age between 60-30 years, Lack of problems and mental illness,Have at least reading and writing education Exclusion criteria:Do not want to cooperate, Be the patient's death for more than 2 years
Intervention groups
In the intervention group, training on the prevention of esophageal cancer behaviors will be done according to the preferred methods that individuals themselves suggest in the qualitative stage. But in the control group, there is no intervention based on education
Main outcome variables
The effect of education on Esophageal Cancer intention and Prevention Behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180725040588N1
Registration date: 2018-10-02, 1397/07/10
Registration timing: prospective

Last update: 2018-10-02, 1397/07/10
Update count: 0
Registration date
2018-10-02, 1397/07/10
Registrant information
Name
sakineh gerayllo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3520 0417
Email address
gerayllo65@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of educational programs based on extended parallel process model (EPPM) in the field of esophageal cancer prevention behaviors among esophageal cancer patients' first-degree relatives with mix method
Public title
The Impact of educational on esophageal cancer prevention behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
suffering one of the family members to esophageal cancer Having no problems and mental illness Have at least reading and writing education
Exclusion criteria:
Be the patient's death for more than 2 years Do not tend to interfere
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random The target group will be divided into two intervention and control groups with using the table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
People entering the study are divided into two groups and only the intervention group will be trained. However, behavioral assessment in both groups will be measured and compared before and after intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd
Street address
Alam Square - Campus of Yazd Shahid Sadoughi University of Medical Sciences
City
yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.SSU.SPH.REC.1396.125

Health conditions studied

1

Description of health condition studied
esophageal cancer
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of oesophagus

Primary outcomes

1

Description
Prevention behaviors score in the questionnaire
Timepoint
2 months after the Educational intervention
Method of measurement
Self-report

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Relatives of patients with esophageal cancer- Educational Content on esophageal cancer prevention behaviors will be given to Intervening people
Category
Behavior

2

Description
Control group: Relatives of patients with esophageal cancer- The control group does not receive any training
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
مراکز شیمی درمانی در بیمارستان های استان گلستان
Full name of responsible person
sakineh gerayllo
Street address
Golestan - 5 Azar Avenue - facing the blood transfusion organization
City
gorgon
Province
Golestan
Postal code
4981168318
Phone
+98 17 3520 0417
Email
gerayllo65@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Square - Headquarters of Shahid Sadoughi University of Medical Sciences and Health Services Yazd - Third Floor
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3726 3733
Email
Mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
sakineh gerayllo
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Imam Khomeini street. first alley
City
Minoodsht
Province
Golestan
Postal code
4981168318
Phone
+98 17 3520 0417
Email
gerayllo65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
sakineh gerayllo
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
University of Medical Sciences, Shahid Sadoughi University of Medical Sciences, Yazd, Iran - Faculty of Health
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
gerayllo65@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
sakineh gerayllo
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
University of Medical Sciences, Shahid Sadoughi University of Medical Sciences, Yazd, Iran - Faculty of Health
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
gerayllo65@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results will be published as an article in the research journals
When the data will become available and for how long
In the next 2 years
To whom data/document is available
Only people who ask for information the main investigator
Under which criteria data/document could be used
With the permission as a written or oral request
From where data/document is obtainable
School of Public Health. Shahid Sadoughi University of Medical Sciences Yazd
What processes are involved for a request to access data/document
With written request, they can access the library of Yazd University of Medical Sciences
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