Intervention Program based of Extended Parallel Process Model(EPPM) among ColoRectal Cancer Patients' First Relatives on Promoting Colonoscopy Screening Test
Determination of the effect of intervention program based of Extended Parallel Process Model among Colo-rectal cancer patients' first relatives on promoting colonoscopy screening test
Design
This study, which was performed among first-degree relatives of patients with colorectal cancer, was a clinical trial with a control group with a simple random sampling method. Using random digit table , the samples were divided into two groups of intervention and control and the number of samples was 62 in each group.
Settings and conduct
Among the first-degree relatives of patients with CRC who referred to public health and service centers in Shiraz, the patients were selected as the research samples.Using random digit table and the samples were divided into two intervention and control groups and the questionnaire was prepared according to the Extended Parallel Process Model(EPPM) for both groups.Educational intervention was performed in the intervention group based on EPPM for reducing fear control. After three months, post test was done in both groups by a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
- ColoRectal Cancer patients' First Relatives
- Aged 20-65 y/o
- Not Cancer
- Live in Fars province
- No history of Dementia or Alzheimer’s
Exclusion Criteria:
- Not interested participation in research
- Death of sample
- Absence of continuous training
- Be Familial Adenomatous Polyposis
Intervention groups
Internationale group is 62 of first-degree relatives of patients with Color-rectal cancer that received educational intervention.
Control group include 62 of first-degree relatives of patients with Colo-rectal cancer that not received educational intervention.
Main outcome variables
Colonoscopy from %10 to %30
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170413033407N2
Registration date:2019-03-01, 1397/12/10
Registration timing:retrospective
Last update:2019-03-01, 1397/12/10
Update count:0
Registration date
2019-03-01, 1397/12/10
Registrant information
Name
Marziyeh Rafatmah
Name of organization / entity
International Campus of Shahid Sadoghi of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 3836 7636
Email address
rafaatmahm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Not have
Expected recruitment start date
2018-02-17, 1396/11/28
Expected recruitment end date
2018-08-20, 1397/05/29
Actual recruitment start date
2018-02-16, 1396/11/27
Actual recruitment end date
2018-08-20, 1397/05/29
Trial completion date
2018-08-20, 1397/05/29
Scientific title
Intervention Program based of Extended Parallel Process Model(EPPM) among ColoRectal Cancer Patients' First Relatives on Promoting Colonoscopy Screening Test
Public title
Colonoscopy Screening Test
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Colo-rectal Cancer Patients' First Relative
None Cancer
Age 20-65
Lives in Fars Provience
No History of Dementia or Alzheimer's
Exclusion criteria:
No interested Participation in Research
Sample Death
The Absence of contentious training
Positive history of Familial Adenomatous polyposis
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Actual sample size reached:
116
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the eligible samples regarding the randomly assigned tables, the participants were divided into two groups of intervention and the control and the educational intervention was conducted in the intervention group.
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
Ethics committee of Shahid Sadoghi university of Medical Science
Street address
Shahid Sadoughi University of Medical Science, Faculty of Health, Alam square, Shohadaye Gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8944157963
Approval date
2017-02-03, 1395/11/15
Ethics committee reference number
IR.SSU.SPH.REC.1395.146
Health conditions studied
1
Description of health condition studied
Colo-rectal cancer
ICD-10 code
C18-C19-C2
ICD-10 code description
بدخیمی در ناحیه کولون - بدخیمی در ناحیه سیگوئید کولون- بدخیمی در ناحیه رکتوم
Primary outcomes
1
Description
Colonoscopy from %10 to %30
Timepoint
Pre educational intervention , 3 months after intervention
Method of measurement
Researcher- made questionnaire based on construction of Extended Process Parallel Model , Kim Witte
Secondary outcomes
empty
Intervention groups
1
Description
In the pre-test, the questionnaire was provided to intervention group. After recognizing that the individuals in the intervention group were in the process of fear control of or threat control, educational content was delivered.Educational intervention content was provided to the intervention group to change that threat control and fear control with items to raise awareness of people about Colo-rectal cancer, risk factors and prevention and specially colonoscopy screening through lecture, pamphlets, booklets,film, posters, and text messages.Three months after the educational intervention in intervention group, post-test was repeated in intervention group .
Category
Prevention
2
Description
Control group: In the pre-test, the questionnaire was provided to control group.Control group didn't receive educational intervention .After three months the educational intervention in intervention group , post-test was repeated in control group. Finally, the educational content packages were also given to the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Marziyeh Rafatmah
Street address
Shahid Sadoghi University of Medical Science, Faculty of Health ,Alam square, Shohadaye Gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8944157963
Phone
+98 35 3836 7668
Fax
+98 35 3836 7636
Email
rafatmahm69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abasali Jaafari
Street address
Bafgh Road,International Campus Shahid Sadoghi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8944157963
Phone
+98 35 3836 7668
Fax
+98 35 3836 7636
Email
rafatmahm69@gmail.com
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
10
Public or private sector
Private
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
Marziyeh Rafatmah
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Bafgh Road ; International Campuse Shahid Sadoghi University of Medical Science
City
yazd
Province
Yazd
Postal code
8944157963
Phone
+98 35 3836 7668
Fax
+98 35 3836 7636
Email
rafatmahm69@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoghi of Medical Science - Faculty of Health
Full name of responsible person
Seyed Saeed Mazloomi Mahmoudabad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Alam square, Shohadaye Gomnam Blvd, Shahid Sadoghi University of Medical Science
City
Yazd
Province
Yazd
Postal code
8944157963
Phone
+98 35 3836 7668
Fax
+98 35 3836 7636
Email
rafatmahm69@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Rafatmah Marziyeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahid Sadoghi University of Medical Sciences , Shohadaye Gomnam Blvd ,Alam square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3836 7668
Fax
+98 35 3836 7636
Email
rafatmahm69@gmail.com
Web page address
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
Yes - There is 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
The information related to the main outcome is possible to be shared
When the data will become available and for how long
After the fulfillment of the thesis
To whom data/document is available
Researchers in the field of cancer and researchers interested to Extended Process Parallel Model