Effect of an intervention based on I-Change model in comparison with existing health education methods on change of intention of women in utilizing preventive services of cancer ( Cervical Cancer)
Objective: Assess the effectiveness of a computer tailored intervention on encouraging women 30-75 in Iran to participate in preventive screening program of cervical cancer
Type: Randomised Controlled Trial among women 30-75 in Tehran, main inclusion criteria is being sexually active and no history of cervical cancer, and main exclusion criteria is age <30 or >75
Sample size will be 300 in three groups, two for intervention and one for control. Case will randomly be allocated and study will be double blind. Participants will receive randomly intervention package which research team do not know about the content.
Group A will receive available information about cervical cancer in national program, group B will receive tailored package and group C will not receive a package immediately, but after intervention phase will receive existing national package.
Total duration of intervention and follow up will be 18 month, including 6 month enrollment and 12 month follow up.
First outcome: change in behavior (making cervical cancer test or follow up)
Second outcome: change in knowledge, attitude and plan of action
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092918120N1
Registration date:2014-09-29, 1393/07/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Kazem Zendehdel
Name of organization / entity
Cancer Research Center, Cancer Institute Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 1638
Email address
kzendeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran university of Medical Science
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-20, 1395/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an intervention based on I-Change model in comparison with existing health education methods on change of intention of women in utilizing preventive services of cancer ( Cervical Cancer)
Public title
Effect of an intervention based on I-Change model in comparison with existing health education methods on change of intention of women in utilizing preventive services of cancer ( Cervical Cancer)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Female; Adult age (30-75); Not virgin( considering sensitivity and privacy of this information, willingness item(item 5, below) with explanation about method of taking sample for Pap smear could cover this); Being resident of Tehran; Being available at least for next six month in that residence or other available address or telephone ;Not attending for Pap smear during last two years
Exclusion criteria: Changing the residence address; Being in the list of preliminary cross sectional study (quantitative study) ;History of cancer; History of hysterectomy ; Illiteracy; Attended for Pap smear during last two years
Age
From 25 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
900
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science
City
Tehran
Postal code
Approval date
2014-08-11, 1393/05/20
Ethics committee reference number
24890
Health conditions studied
1
Description of health condition studied
Cervical Cancer
ICD-10 code
N87
ICD-10 code description
Dysplasia of cervix uteri
Primary outcomes
1
Description
change in behavior (making cervical cancer test or follow up)
Timepoint
6-12 Month after intervention
Method of measurement
questionnaire and observation
Secondary outcomes
1
Description
change in knowledge, attitude and plan of action
Timepoint
4wks after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Group A intervention:
will receive PHC available package for cervical cancer screening
Category
Behavior
2
Description
Group B:
will receive tailored intervention package for cervical cancer screening
Category
Behavior
3
Description
group C:
Will not receive a package before finishing intervention in groups A and B, then for ethical reasons will receive PHC package
All packages will have information about cervical cancer screening, centers for referral and hot line number for questions
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Research Center, Cancer institute of I.R of Iran
Full name of responsible person
Rahim Taghizadeh Asl
Street address
Imamkhomeini Hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of medical science
Full name of responsible person
Dr Masoud Younesian
Street address
Dameshgh Str., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of medical science
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
CRC, Cancer Institute of Iran
Full name of responsible person
Rahim Taghizadeh Asl
Position
PhD student
Other areas of specialty/work
Street address
Imam Khomeinin Hosptial , Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6658 1638
Fax
Email
taghizadehasl@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
CRC, Cancer Institute of Iran
Full name of responsible person
Rahim Taghizadeh Asl
Position
MD
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6658 1638
Fax
Email
taghizadehasl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cancer Research Center
Full name of responsible person
Rahim Taghizadeh Asl
Position
MD, MPH
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 912 320 1006
Fax
Email
taghizadehasl@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)