Determining the effect of Peer Education on Cluster Symptoms and Self-Efficacy in Patients with Breast Cancer
Design
A randomized clinical trial with two groups of test and control , with 100 subjects as sample size, a purpose-based sampling method and dividing subjects into two groups of test and control
Settings and conduct
his clinical trial study was conducted on 100 breast cancer patient. The location of the study was the Omid Medical Education Research Center in Isfahan city.
Participants/Inclusion and exclusion criteria
Patients diagnosed with breast cancer .patients with ability to read and write.
Intervention groups
In the test group, in addition to the current education by healthcare personnel, eight sessions were conducted per week and each session lasted for 60 minutes. The control group received to the current education by healthcare personnel.
Main outcome variables
Cluster Symptoms؛ Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190627044033N1
Registration date:2019-07-08, 1398/04/17
Registration timing:retrospective
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Farzaneh Kamaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3681 5611
Email address
it_shahreza@phc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
2018-06-26, 1397/04/05
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-03-06, 1397/12/15
Scientific title
The Effect of Peer Education on Cluster Symptoms and Self-Efficacy in Patients with Breast Cancer
Public title
Peer Education on Cluster Symptoms and Self-Efficacy in Breast Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with breast cancer
patients with ability to read and write
patients aged 35 and over
Exclusion criteria:
Patients with physical and mental disabilities
Patients with known psychiatric disorders
Age
From 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of this study is simple randomization. One hundred Patients with diagnosed of breast cancer who had inclusion criteria and tend to participate in this study. A code was assigned to each person. they were divided into intervention and control groups by applying the Random number table.
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
thics Committee of Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Islamic Azad University Isfahan (Khorasgan) Branch., University Blvd., Jey St., Isfahan town
City
Eefahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.084
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
Cluster Symptoms
Timepoint
The measurement of mean of the cluster symptoms before the intervention and one month after the end of the intervention.
The measurement of mean of the self efficacy before the intervention and one month after the end of the intervention.
Method of measurement
Sherer General Self-Efficacy Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group held 8 peer education sessions in the field of physical, psychological, social and behavioral issues per week, and each session was 60 minutes.
Category
Lifestyle
2
Description
Control group: receives only current education by healthcare personnel.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Medical Education Research Center
Full name of responsible person
Farzane Kamaee
Street address
Omid Medical Education Center., Khayyam St., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3236 8005
Fax
+98 31 3236 8005
Email
fkamaee@yahoo.com
Web page address
http://omid.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Navid Nasirizade
Street address
Deputy of research and technology., Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
research@iauyazd.ac.ir
Web page address
http://www.iauyazd.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Masoumeh Barkhordari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
barkhordary_m@yahoo.com
Web page address
https://www.iauyazd.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Barkhordari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
barkhordary_m@yahoo.com
Web page address
http://www.iauyazd.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzane Kamaee
Position
Master degree in Medical Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
fkamaee@yahoo.com
Web page address
http://www.iauyazd.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available