Design, Implementation and Evaluation of theory–based intervention program on promoting screening behavior of breast cancer in employed women University of Medical Sciences
The purpose of this study was to design, implement and evaluate a theoretical-focused interventional program to promote breast cancer screening behavior in employed women.
Design
The study will be conducted in two stages: descriptive-analytical and interventional. A descriptive step is to measure the extent of screening behavior and determine behavior predictors. In the intervention phase, women with low screening behaviors are included in the study.
Settings and conduct
This study was conducted in Hamedan, Iran, in all the departments of the University of Medical Sciences.
Blinding in the study is only for Women participating.
Participants/Inclusion and exclusion criteria
Having ages 61 to 20 years, having no breast cancer and having satisfaction to participate in the study
Intervention groups
"Intervention group": Employed women with low screening behavior
Main outcome variables
Screening behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171224038026N1
Registration date:2018-04-27, 1397/02/07
Registration timing:prospective
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
mitra dogonchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0360
Email address
m.dogoonchi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of theory–based intervention program on promoting screening behavior of breast cancer in employed women University of Medical Sciences
Public title
Effect of theory–based intervention program on promoting screening behavior of breast cancer in employed women
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Having ages 61-20 years
Not having breast cancer
Having the consent to participate in the study
Exclusion criteria:
Age less than 20 years
Having breast cancer
discontent to participate in the study
Age
From 20 years old to 69 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are unaware of being in the intervention and control group. The names of people will be selected in lottery and will be placed in one of the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
After preparing the plan names so that participants do not understand which of the control or intervention groups, respectively
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Assistance Research & Technology University of Medical Sciences
Street address
Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.UMSHA.REC.1396.609
Health conditions studied
1
Description of health condition studied
Increased screening
ICD-10 code
Z12.3
ICD-10 code description
Encounter for screening for malignant neoplasm of breast
Primary outcomes
1
Description
Doing behavior Screening
Timepoint
Before the intervention and one month and three months after the intervention
Method of measurement
Report behavior screening Through the questionnaire
Secondary outcomes
1
Description
Screening behavior
Timepoint
Before the intervention one month and three months after the intervention
Method of measurement
questionnaire
2
Description
Knowledge
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
3
Description
Perceived sensitivity
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
4
Description
Perceived severity
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
5
Description
Reward
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
6
Description
Response Costs
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
7
Description
fear
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
8
Description
Self Efficacy
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
9
Description
Response Efficacy
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
10
Description
Treat Appraisal
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
11
Description
Coping Appraisal
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
12
Description
Motivation
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
13
Description
Health Promotion
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
14
Description
Screening Behavior of Breast Cancer
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
15
Description
Social Support Theory
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
16
Description
Emotional Support
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
17
Description
Information Support
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
18
Description
Instrumental Support
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
19
Description
Appasial Support
Timepoint
Before and one and three months after the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
"Intervention group": 3 training sessions for 90 minutes, 2 sessions, 60 minutes workshop, one instruction book, one instructional film, 3 pamphlets, 1 posters, 3 photo clips and e-learning
Category
Behavior
2
Description
"Control group": Distribution of booklets and pamphlets and educational CDs
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
All Department of University of Medical Sciences
Full name of responsible person
Mitra Dogonchi
Street address
Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 17 3452 1398
Email
dogonchi.mitra@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
saied bashirian
Street address
Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 17 3452 1398
Email
dogonchi.mitra@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
mitra dogonchi
Position
Ph.D. student health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 17 3452 1398
Email
dogonchi.mitra@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mitra dogonchi
Position
Ph.D. student health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 17 3452 1398
Email
dogonchi.mitra@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mitra dogonchi
Position
Ph.D. student health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 17 3452 1398
Email
dogonchi.mitra@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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