Objectives: the aim of this study is to assess the effect of psycho-educational intervention through mobile technologies on self-esteem and anxiety in women with non-metastatic breast cancer. Design:in this randomized control trial, at least 60 women aged 20-60 years old with non-metastatic breast cancer will be chosen by simple random allocation method then they will be randomly divided into control and intervention groups by block randomization by a research assistant. To avoid bias, double blinding method will be used for statistical analyst and the researcher. Setting: breast cancer clinics of Shiraz, Iran. Intervention: this 4 weeks program has 2 parts, first psycho-educational interventions will be done through mobile application for the experimental group and then discussion in online chat rooms of social networks will be performed at the end of each weeks. Main outcome: level of self-esteem and anxiety will be assessed before and immediately one week after the intervention using Spielberger state trait anxiety inventory and Rosenberg self-esteem questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072123279N2
Registration date:2016-07-08, 1395/04/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-08, 1395/04/18
Registrant information
Name
Shahrzad Yektatalab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
yektash@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Shiraz 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 Effect Of Psycho-Educational Interventions Through Mobile Technologies On Self-Esteem And Anxiety In Women With Breast Cancer
Public title
The Effect Of Psycho-educational Interventions On Self-esteem And Anxiety In Women With Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 20-60 years old ; willingness to participate in the research ; suffering from non-metastatic cancer ; being able to read and write ; having access and being able to use a smart phone and internet and social network.
Exclusion criteria: irregular participation in the treatment sessions ; suffering from any serious diseases other than breast cancer ; a history of chronic mental disease or use of psychiatric drugs ; a history of participation in the psycho-education courses similar to the application's content.
Age
From 20 years old to 59 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Of Medical Sciences
Street address
Zand street, Shiraz University Of Medical Sciences
City
Shiraz
Postal code
71348-14336
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.SUMS.REC.1395.20
Health conditions studied
1
Description of health condition studied
Organic anxiety disorder
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
2
Description of health condition studied
Self-esteem
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Anxiety
Timepoint
before the intervention, 1 week after the intervention
Method of measurement
Spielberger State Trait Anxiety Inventory
2
Description
Self-esteem
Timepoint
before the intervention, 1 week after the intervention
Method of measurement
Rosenberg Self-Esteem Scale
Secondary outcomes
empty
Intervention groups
1
Description
No intervention considered for the control group.
Category
N/A
2
Description
Psycho_educational interventions will be done for the experimental group through smartphone application, members can interact with each other and the researcher via social network for 1 month. Their activity will be assessed during the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari polyclinic
Full name of responsible person
Dr hossein jamali
Street address
Namazi square
City
Shiraz
2
Recruitment center
Name of recruitment center
Emam Reza polyclinic
Full name of responsible person
Dr hossein jamali
Street address
Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Zand street, Shiraz University of Medical Sciences;Vice President of Research
City
Shiraz
Grant name
Grant code / Reference number
10534
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shiraz 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
Fatemeh School of Nursing and Midwifery
Full name of responsible person
Elaheh Ghanbari
Position
Master of Nursing Student
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Namazi square
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
stud2280422123@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
Assistant professore
Other areas of specialty/work
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
yektash@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
Assistant professore
Other areas of specialty/work
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
yektash@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)