Major eligibility objectives: The determination of impact of education based on Health Belief Model on promoting Self -care behaviors in first degree relatives of breast cancer patients
Design:clinical trial phase 2-3.
Setting and Conduct: After explaining The purpose of the study to the participants, as the pretest, questionnaires in the context of demographic characteristics, knowledge, beliefs about breast cancer with the use of health belief model and self-care behaviors affecting breast cancer and also perceived stress were filled up by both control and intervention groups. Educational content based on Health Belief Model was presented to intervention group. Eight weeks after education, the same questionnaires were filled up as the post test. At the end of the study, educational booklets were given to both groups.
Participants: 76 females who had the history of breast cancer in first degree relatives and were literate that were willing to participate in the study, were included in the study; And who didn't desire to participate or had suspicious ultrasound or mammogram or were absent in more than one session, were excluded.
Interventions: In the intervention group,four educational sessions, each one lasted 90 seconds,were held based on health belief model.The control group participates didn't receive any education.
main outcome: self-care behaviors
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129446N1
Registration date:2017-04-26, 1396/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-26, 1396/02/06
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of education based on Health Belief Model on promoting Self -care behaviors in first degree relatives of breast cancer patients
Public title
The impact of education on self-care behaviors affecting breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having the minimum literacy; Lack of any known cancer; No known mental illness; Having a family history of breast cancer in the first degree relatives (mother, sister, daughter); Willingness to cooperate.
Exclusion criteria: suspicious mass on ultrasound or mammogram; Absence in more than one training session; Not willing to continue cooperation.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods street, Enghelab squer, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
IR.TUMS.VCR.REC.1395.60
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
self - care behaviors
Timepoint
Before and 2 months after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Awareness
Timepoint
Before and 2 months after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
In the intervention group,four educational sessions, each one lasted 90 seconds,were held based on health belief model.The content of education were The anatomy of breast, defining the breast cancer and its types, symptoms and risk factors of breast cancer, complications and consequences of late diagnosis, effective self-care behaviors on prevention and early detection of breast cancer, the expression of incorrect beliefs about breast cancer and self-care. The methods including lecture, group discussion, question and answer, were used. Self-care assessments were done before and two months after intervention.
Category
Prevention
2
Description
The control group participates didn't receive any education. Evaluation of self-care behaviors were done before and two months after intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital
Full name of responsible person
Dr Mahmoudi
Street address
Imam Khomeini Hospital,The end of Keshvarz Blvd,Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences