The aim of the study is to determine the effect of motivational interviewing(MI) on breast cancer screening behaviors of rural women. Type of the study is randomized controlled trial intended to compare change stages of clinical breast exam and mammography between two (MI and control) groups, baseline and 2 months after the intervention. The sample size is 60 rural women ageing 40 to 69 years from Abesh Ahmad, Kaleybar. For case group, motivational interviewing will held in 6 sessions twice a week for 90-60 minutes. Each group contains 8-12 women. The control group will participate in two educational sessions about cervical cancer screening.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050933834N1
Registration date:2017-06-06, 1396/03/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Motivational Interviewing on Breast Cancer Screening Behaviors of Rural Women: A Randomized Controlled Clinical Trial
Public title
The Effect of Motivational Interviewing on Breast Cancer Screening Behaviors of Rural Women: A Randomized Controlled Clinical Trial
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: Women ages 40 to 69 years; Negative history of mammography in the past two years; Negative history of clinical breast examination during the past year; breast control less than four times over the past year; No history of breast cancer or a history of breast cancer in first degree relatives; Enable to speak and listen, Telephone number for follow up
Exclusion criteria: Pregnant and lactating women; Galactorrhea; The history of participation in educational sessions related to breast cancer; Physical and Mental disability
Age
From 40 years old to 69 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz University of Medical Sciences (Nursing and Midwifery)
Street address
Azady Street / Golgasht (South Shariati)
City
Tabriz
Postal code
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.TBZMED.REC.1396.113
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Change stages of clinical breast exam and mamography
Timepoint
Before and two months after intervention
Method of measurement
Checklist of change stages of clinical breast exam and mamography
Secondary outcomes
1
Description
change stages of breast control
Timepoint
Before and 2 months after intervention
Method of measurement
Checklist of change stages of breast control
2
Description
Breast cancer awareness
Timepoint
before and 2 months after intervention
Method of measurement
BCAM Questionnaire
Intervention groups
1
Description
In the intervention group (n = 30), six group sessions twice a week will held with 8-12 women. Duration of each session would be 90-60 minutes . The final session would be 120-100 minutes.
Category
Prevention
2
Description
Two educational sessions about cervical cancer screening will held in the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Najaf Health Home
Full name of responsible person
Parvin Alizadeh Sabeg
Street address
Kaleybar/ Abesh Ahma / Najaf
City
Kaleybar / Abesh Ahmad/ Najaf
2
Recruitment center
Name of recruitment center
Ajdan Abad Health Home
Full name of responsible person
Parvin Alizadeh Sabeg
Street address
Kaleybar / Abesh Ahmad / Ajdan Abad
City
Kaleybar / Abesh Ahmad / Ajdan Abad
3
Recruitment center
Name of recruitment center
Sardar Abad Health Home
Full name of responsible person
Parvin Alizadeh Sabeg
Street address
Kaleybar / Abesh Ahmad / Sardar Abad
City
Kaleybar/ Abesh Ahmad / Sardar Abad
4
Recruitment center
Name of recruitment center
Ghalekandi Health Home
Full name of responsible person
Parvin Alizadeh Sabeg
Street address
Kaleybar / Abesh Ahmad / Ghalekandi
City
Kaleybar / Abesh Ahmad / Ghalekandi
5
Recruitment center
Name of recruitment center
Amir Abad Health Home
Full name of responsible person
Parvin Alizadeh Sabeg
Street address
Kaleybar / Abesh Ahmad / Amir Abad
City
Kaleybar / Abesh Ahmad /Amir Abad
6
Recruitment center
Name of recruitment center
Kalantar Health Home
Full name of responsible person
Parvin Alizadeh Sabeg
Street address
Kaleybar / Abesh Ahmad /Kalantar
City
Kaleybar / Abesh Ahmad / Kalantar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice President of Research, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Alizadeh Sabeg
Position
MSc of Counseling in Midwifery
Other areas of specialty/work
Street address
Azadi Street / Golgasht (South Shariati Ave/School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
parvinalizadeh15@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences (Faculty of Nursing and Midwifery)
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
PhD in reproductive health
Other areas of specialty/work
Street address
Azadi Street / Golgasht (South Shariati Ave/Faculty of Nursing and Midwifery)
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
nourizadehr@tbzmed.ac.ir /rnourizadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences (Faculty of Nursing and Midwifery)
Full name of responsible person
Parvin Alizadeh Sabeg
Position
MSc of Counseling in Midwifery
Other areas of specialty/work
Street address
Azadi Street / Golgasht (South Shariati Ave)/ Faculty of Nursing and Midwifery
City
Tabrize
Postal code
Phone
+98 41 3479 6770
Fax
Email
parvinalizadeh15@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)