Investigating the effect of counseling based on Information-Motivation- Behavior (IMB) Model on the breast cancer risk perception and behavioral changes of the families of women with breast cancer
Determining the effect of counseling based on behavior motivation information model on risk perception and behavioral changes of the families of women with breast cancer
Design
Clinical trial with control group, intervention, simple randomization, 38 patients in the intervention, 38 patients in the control group
Settings and conduct
In women's health care centers of Sarvestan city, women who have a family history of breast cancer are divided into control and intervention groups. Both groups fill out the breast cancer risk perception questionnaire and health behavior changes questionnaire one week before starting the intervention. The intervention group receives counseling. Then, each group fills out the breast cancer risk perception questionnaire and health behavior changes questionnaire immediately after the consultation.
Participants/Inclusion and exclusion criteria
Having a family history of breast cancer, age 20 to 65 years, telephone access,
not being deaf and having hearing and learning problems, ability to speak Persian, no history of breast cancer
Intervention groups
The effect of counseling based on information motivation behavior model on risk perception and behavioral changes in the intervention group and lack of advice in the control group and just filling in the questionnaire
Main outcome variables
Breast cancer risk perception; behavioral changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151103024866N21
Registration date:2024-07-11, 1403/04/21
Registration timing:registered_while_recruiting
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-06, 1403/04/16
Expected recruitment end date
2025-01-05, 1403/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of counseling based on Information-Motivation- Behavior (IMB) Model on the breast cancer risk perception and behavioral changes of the families of women with breast cancer
Public title
Effect of counseling based on Information-Motivation- Behavior (IMB) Model on the breast cancer risk perception and behavioral changes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All women who have a family history of breast cancer (mother, daughter, sister and sister's daughter of women with breast cancer)
Having the age of 20 to 65 years
Having access to the phone
Not having hearing and learning problems
Being able to speak Persian
Exclusion criteria:
Having history of breast cancer
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in an available manner and will be randomly placed in two intervention and control groups in a block method. To allocate participants in research groups, a computerized list of random numbers will be used to randomly assign subjects in blocks. 4 will be determined by the statistical consultant and R statistical software. Then the allocation of participants will be done by a member of the research team who is not related to them with a 1:1 allocation ratio within the training groups. The sequence of allocation will be concealed by sequentially numbered opaque envelopes, and the envelopes will be opened only after all initial and baseline assessments of participants have been completed. The sequence of random allocation will remain confidential from the assessors and other research colleagues. Due to the nature of the study, the evaluator does not know the division of participants into groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences Et
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-05-06, 1403/02/17
Ethics committee reference number
IR.KMU.REC.1402.482
Health conditions studied
1
Description of health condition studied
Breast cancer risk perception
ICD-10 code
Z80.3
ICD-10 code description
Family history of malignant neoplasm of breast
2
Description of health condition studied
Health behavioral change
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Breast cancer risk perception score from the TRIRISK questionnaire
Timepoint
Before the intervention and after completion of conseling sessions
Method of measurement
TRIRISK questionnaire
2
Description
Health behavioral change score from the behavioral change questionnaire
Timepoint
Before intervention and after completion of conseling session
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is based on the model of information, motivation and behavioral skills, which is an intervention in accordance with the needs of the target group. Based on this model, with the necessary information about the deficiencies in the information, motivation and behavioral skills of the patients' family group, through interviews, focus groups and other methods, and then design an intervention based on this model for the patients' family group. will be. The intervention will be based on face-to-face motivational interviews. The intervention will be conducted in two groups of 19 people for 4 sessions (once a week) and for 1 hour. The intervention based on this model will include three parts: information, motivation and behavioral skills. The information is presented in the form of a lecture using appropriate educational tools (slides, educational videos, whiteboards, markers, etc.) in order to provide better information to the patients' families and includes the definition of breast cancer, the definition of risk perception, the definition Health-related behaviors are the full expression of the risk factors of breast cancer. In the motivation part, a motivational interview is conducted to accept or change health-related behaviors and reduce the risk of cancer, and in the next session, in the form of obtaining information about the person's current condition, the reasons The need to change the current behavior, feedback and confirmation and strengthening of the person to change the behavior will be presented in the form of a discussion and an effort will be made to improve the individual skills and perceived self-efficacy of the person with behavioral techniques such as role playing and finally in the meeting Next, in order to activate avoidance behaviors and improve assertiveness skills, people will be counseled by increasing motivation and behavioral skills, and behavioral techniques will be taught.
Category
Behavior
2
Description
Control group: No intervention will be received and only complete the questionnaire
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of Sarvestan City
Full name of responsible person
Fateme Bijani Koochi
Street address
Crossroad of Behdari, Sarvestan Health and Treatment Network
City
Sarvestan
Province
Fars
Postal code
7345157441
Phone
+98 71 3784 6969
Email
Hnybjn74@gmail.com
Web page address
http://sarvestan.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Deputy of research and technology, somaye crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of midwifery, Razi faculty of nursing and midwifery, kerman university of medical sciences campus, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
alidoosti@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Central Building, Kerman University of Medical Sciences, Shafa Crossroads, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
alidoosti@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Central Building, Kerman University of Medical Sciences, Shafa Crossroads, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
alidoosti@kmu.ac.ir
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