Protocol summary

Summary
Objectives: The effect of an educational intervention regarding the warning signs of cancer in knowledge and perceived beliefs of women in the Health Centers related to the Bushehr University of Medical Sciences by applying the Health Belief Model, 2015-2016 Specific objectives: (1) To determine the awareness of women referred to health centers affiliated to Bushehr University of Medical Sciences in the intervention and control groups before and after training warning signs of cancer with the approach of Health Belief Model,2015- 2016. (2) Determine and compare the beliefs of women referred to health centers affiliated to Bushehr University of Medical Sciences According to the health belief model structures in the intervention and control groups before and after training warning signs of cancer with the approach of Health Belief Model,2015- 2016. Design: This study is an experimental study with intervention (n=80) and control (n=80) groups. First of all urban health centers affiliated to Bushehr University of Medical Sciences classified in four clusters and then to select two examples of the intervention group and the control group were two samples to select Setting and conduct: After oral and written consent from research participants research data were collected by a questionnaire. The first part of the questionnaire was demographic – health information (16 questions). In the second part, questions about awareness the warning signs of cancer (10 questions), and in the third part of the questionnaire, there was a series of questions about Health Belief Model constructs, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action and self-efficacy (34 questions). Face validity and content quality of the questionnaire was approved by 10 faculty members in Shahid Beheshti University of Medical Sciences. Participants including major eligibility criteria: Inclusion criteria: women referred to health centers of the city are covered by the centers and family health records. The subjects were literate and be able to respond to questions in the questionnaire. Of samples in the study were not diagnosed with cancer.Exclusion criteria: participation in training sessions and absences in more than one session Intervention: During the first session, a pre test questionnaires containing demographic information - health and perceived knowledge and beliefs (questions based model structures) by the women in the study in two groups of four health center completed.After pre-test according to information obtained from the analysis of questionnaires, review of educational intervention program was designed. Then, for the women in the intervention group training sessions with lectures, question and answer, group discussion and small group discussion in two of the samples performed in coordination with the authorities and centers (5 sessions, 45-30 minutes).Meetings once a week over a period of five weeks was held in centers. Entries in the form of booklets based on needs assessments conducted in the pre-test, teaching, and at the end of each session, participants in the intervention group were offered. At the beginning of each session, the last session was an overview of the content.Thus, in both the intervention and control groups completed questionnaires and data for comparisons within the group and between groups were analyzed. It is worth noting that in the end, after the final post test control group were given educational materials. main outcome measures (variables): Perceived barriers Awareness of the warning signs of cancer Structural health belief model (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, efficacy) Age Level of Education Previous data from cancer

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090723937N1
Registration date: 2016-10-15, 1395/07/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-15, 1395/07/24
Registrant information
Name
Iman Sharifi Kia
Name of organization / entity
Shiraz of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3834 1255
Email address
sharifikia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational intervention regarding the warning signs of cancer in knowledge and perceived beliefs of women who are coming to the health centers related to the Bushehr University of Medical Sciences by applying the Health Belief Model, 2014-2015
Public title
The effect of an educational intervention regarding the warning signs of cancer in knowledge and perceived beliefs of women who are coming to the health centers related to the Bushehr University of Medical Sciences by applying the Health Belief Model, 2014-2015
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women referred to health centers of the city are covered by the centers and family health records. The subjects were literate and be able to respond to questions in the questionnaire. Of samples in the study were not diagnosed with cancer;Exclusion criteria: participation in training sessions and absences in more than one session
Age
From 18 years old to 100 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Bushehr University of Medical Sciences Ethics Committee
Street address
Salman Farsi street, Bahmani
City
Bushehr
Postal code
7518759577
Approval date
2015-07-20, 1394/04/29
Ethics committee reference number
bpums.rec.1394.9

2

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery Ethics Committee
Street address
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery,Intersection Niayesh, Tehran
City
Tehran
Postal code
Approval date
2015-12-14, 1394/09/23
Ethics committee reference number
IR.SBMU.PHNM.1299.339

Health conditions studied

1

Description of health condition studied
Health Belief Model
ICD-10 code
ICD-10 code description

2

Description of health condition studied
knowledge
ICD-10 code
ICD-10 code description

3

Description of health condition studied
cancer
ICD-10 code
c80.9
ICD-10 code description
Malignant neoplasm, primary site unspecified Cancer NOS Carcinoma NOS Malignancy NOS Malignant cachexia NOS Multiple cancer NOS

4

Description of health condition studied
warning signs of cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Perceived barriers
Timepoint
Before and one month after intervention
Method of measurement
Structure of Health Belief Questionnaire

2

Description
Awareness of the warning signs of cancer
Timepoint
Before and one month after intervention
Method of measurement
Questionnaire awareness

3

Description
Perceived susceptibility
Timepoint
Before and one month after intervention
Method of measurement
Structure of Health Belief Questionnaire

4

Description
Perceived severity
Timepoint
Before and one month after intervention
Method of measurement
Structure of Health Belief Questionnaire

5

Description
Perceived benefits
Timepoint
Before and one month after intervention
Method of measurement
Structure of Health Belief Questionnaire

6

Description
Guide to action
Timepoint
Before and one month after intervention
Method of measurement
Structure of Health Belief Questionnaire

7

Description
Efficacy
Timepoint
Before and one month after intervention
Method of measurement
Structure of Health Belief Questionnaire

8

Description
Age
Timepoint
Baseline
Method of measurement
Demographic questionnaire.

9

Description
Level of Education
Timepoint
Baseline
Method of measurement
Demographic questionnaire.

10

Description
Previous data from cancer
Timepoint
Before and one month after intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Cases: In this study, after obtaining permission first 11 urban health center affiliated city health center were classified in four clusters (Each cluster consists of three centers of the North, East, West and also the center of a cluster depend on the outskirts of the city of Bushehr found). Then randomly selected from each of the clusters was a center (Two to be selected for the intervention group and two samples of the control). Samples were selected in the centers, according to inclusion criteria were randomly.During the first session, a pre-test questionnaires containing demographic information - health and perceived knowledge and beliefs (questions based model structures) by the women in the study in two groups of four health center completed. After running pre test according to information obtained from the analysis of questionnaires, review of educational intervention program was designed. Then, for the women in the intervention group training sessions with lectures, Q & A, group discussion and small group discussion in two of the samples performed in coordination with the authorities and centers (5 training sessions of 30-45 minutes). Sessions once a week over a period of five weeks are held in centers.After the post-test at the end of training sessions, the questionnaire was completed by a group intervention.
Category
Behavior

2

Description
Control group: firstly to all participants in the control group and the intervention group was completed questionnaires were distributed and only by them (without any training). Finally, after the final post-test training materials available in the intervention group was the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr University of Medical Sciences
Full name of responsible person
Sharifikia Iman
Street address
Bushehr University of Medical Sciences and Health Services,Moallem st, Standing in front of Friday Prayers
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences Faculity Of Nursing And
Full name of responsible person
Dolatian Mahrokh (Research Assistant)
Street address
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery, Intersection Niayesh,Tehran
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,Shahid Beheshti University of Medical Sciences Faculity Of Nursing And
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
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery
Full name of responsible person
Sharifikia Iman
Position
M.A Student
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery,Intersection Niayesh, Tehran,
City
Tehran
Postal code
Phone
+98 21 8820 2508
Fax
Email
Sharifikia@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery
Full name of responsible person
Rohani Camelia
Position
P.H.D Nursing
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery, Intersection Niayesh,Tehran
City
Tehran
Postal code
Phone
+98 219122796907
Fax
Email
Camelia.rohani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery
Full name of responsible person
Sharifikia Iman
Position
M.A student
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences Faculity Of Nursing And Midwifery, Intersection Niayesh, Tehran
City
Tehran
Postal code
Phone
+98 939 319 3750
Fax
Email
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
Loading...