Design, implementation and evaluation of the intervention based on intervention mapping (IM) approach on breast cancer screening with mammography in Fasa city women
Determining the effectiveness of intervention mapping approach in breast cancer prevention using mammography
Design
A clinical trial with a control group, a blind strain, randomized, is conducted on 300 participants.
Settings and conduct
Intervention in the field of mammography screening in health centers is carried out in two intervention and control groups. The selection of participants is voluntary and the intervention and control groups are done in separate centers so that the people of the groups are not in contact with each other.
Participants/Inclusion and exclusion criteria
Informed written consent, literate, between 40 and 59 years old, able to participate in educational classes, having an active health record.
Intervention groups
In this study, the effect of the intervention in increasing breast cancer screening in the intervention and control groups is investigated.
Main outcome variables
mammography; breast self-examination; Increasing awareness ; removing barriers to screening; Reducing stress ; improving health care; Coherent training
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230617058501N1
Registration date:2023-12-02, 1402/09/11
Registration timing:prospective
Last update:2023-12-02, 1402/09/11
Update count:0
Registration date
2023-12-02, 1402/09/11
Registrant information
Name
asiyeh yari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 8583
Email address
a.yari@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of the intervention based on intervention mapping (IM) approach on breast cancer screening with mammography in Fasa city women
Public title
Mammography in breast cancer screening
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 40 to 59 who have not had a mammogram
Exclusion criteria:
People with breast cancer
Age
From 40 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 4 comprehensive health service centers in Fasa, two comprehensive health service centers were selected, which in terms of distance and geographical distance have the least probability of contact between the two intervention and control groups, and randomly the referents of a comprehensive health service center as the intervention group and the referents. The other center is divided as a control group. Then, with the introduction letter in hand, the vice president of research of the university will refer to those centers. Sampling in each comprehensive health service center will be done in a simple random manner and based on the electronic health record of the said centers' Sib system and based on the entry criteria.
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 Hormozgan University of Medical Sciences
Street address
Bandar Abbas, Shahid Chamran Blvd., Hormozgan University of Medical Sciences and Health Services Postal code: 13885-79166
City
Bandar Abbas
Province
Hormozgan
Postal code
13885-79166
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.HUMS.REC.1402.101
Health conditions studied
1
Description of health condition studied
Mammography in women aged 40 to 59 years
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people who do mammography screening
Timepoint
Mammography screening measurement will be at the beginning of the study (before the start of the intervention) three and six months later
Method of measurement
Using a questionnaire and sheet containing mammography results
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will conduct a training course on breast cancer prevention and mammography screening. Training methods will include face-to-face training and lectures. The training sessions will be according to the pre-test results. The control group will not receive any training but will receive a training package at the end of the study. Before the intervention and 3 months after the intervention, the questionnaire will be completed by the study subjects and the results will be reviewed and reported.
Category
Prevention
2
Description
The control group will not receive any training but will receive a training package at the end of the study. Before the intervention and 3 months after the intervention, the questionnaire will be completed by the study subjects and the results will be reviewed and reported
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers of Fasa city
Full name of responsible person
Laleh Hassani
Street address
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
City
Bandar Abbas
Province
Hormozgan
Postal code
13885-79166
Phone
+98 912 239 1104
Email
7hassani1969@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Vali Alipour
Street address
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
City
Bandar abbas
Province
Hormozgan
Postal code
13885-79166
Phone
+98 912 239 1104
Email
7Hassani1969@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Asiyeh Yari
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
City
Bandar abbas
Province
Hormozgan
Postal code
3885-79166
Phone
+98 935 365 9320
Email
Yariasi98@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Asiyeh Yari
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
City
Bandar abbas
Province
Hormozgan
Postal code
13885-791661
Phone
+98 935 365 9320
Email
Yariasi98@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Asiyeh Yari
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
City
Bandar abbas
Province
Hormozgan
Postal code
13885-79166
Phone
+98 935 365 9320
Email
Yariasi98@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