The purpose of the study is to determine the application Orem's self-care training program on quality of life for breast cancer patients undergoing chemotherapy. 80 eligible patients were selected by sampling from available target based Shiraz oncology centers, and randomly classified into two test (40) and control (40) groups. The main inclusion criteria: women with breast cancer aged 18 to 69 years, spend at least on course of chemotherapy, self-care ability and exclusion criteria: women with breast cancer were older than 69 years, unwillingness to cooperate and death. Breast cancer quality of life questionnaire and demographic information before the intervention was completed by test and control groups. The training needs of patients in the test groups was obtained through completing the Orem's needs assessment form. The 8-session self-care program based on Orem's pattern during two months for educational counseling was conducted .it was 45-minute discussion lecture for the test group on the patient's needs. At the beginning of the intervention the test group received training booklet and checklist of daily activities. Two weeks after the last session, Breast Cancer Quality of Life Questionnaire again was completed by the two groups. The obtained data before and after the implementation of the program were analyzed in test and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042921425N2
Registration date:2016-05-23, 1395/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Shekoofeh Hamzehiekia
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 7251
Email address
sh.hamzhiekia@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Yasuj University of Medical Science
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Orem's Self Care training program on quality of life in breast cancer patients undergoing chemotherapy oncology centers in Shiraz
Public title
The effect of education on life of breast cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women with breast cancer aged 18 to 69 , self-care ability, spend at least on course of chemotherapy, lack of specific mental disorder such as major depression or bipolar disorder and neurological disorder, lack of chronic diseases such as MS, history of other malignancies, Lack of vision and hearing disorders. Exclusion criteria: women with breast cancer were older than 69 years, unwillingness to cooperate and death.
Age
From 18 years old to 69 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Yasuj University of Medical Science
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Approval date
2014-08-27, 1393/06/05
Ethics committee reference number
93061003
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
Quality of life
Timepoint
Before intervention, two weeks after intervention
Method of measurement
QLQ-BR23, QLQ C30 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
8 sessions self care program based on Orem's model is conduct during two months،once a week for 45 minutes . the training counseling is through lectures and discussion for patients in experimental group based on educational needs
Category
Lifestyle
2
Description
The control group will not received intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Shekoofeh Hamzheekia
Street address
Namazi Hospital, Namazi Square, Zand Ave, Shiraz, Fars
City
Yasuj
2
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Shekoofeh Hamzheekia
Street address
Motahari Clinic, Namazi Square, Zand Ave, Shiraz, Fars
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Yasuj University of Medical Science
Full name of responsible person
Mahmood Naraki
Street address
Vice Chancellor for Research of Yasuj University of Medical Science, ground floor, Center Building of Yasuj University of Medical Sience, Setad, Shahid Motahari Boulevard, Yasuj.
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Yasuj University of Medical Science
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
Yasuj university of Medical Science
Full name of responsible person
Shekoofeh Hamzheekia
Position
Master of Medical Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Second floor, Yasuj University of Medical Science, next to Emam Sajad hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 1333 7370
Email
Hamzeieki@yahoo.com
Web page address
www.yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr. Ardashir Afrasyabifar
Position
PHD in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 1333 7370
Email
Afrasiabifar@yahoo.com
Web page address
www.yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Shekoofeh Hamzheekia
Position
Master of Medical Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil Boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 1333 7370
Email
Hamzeieki@yahoo.com
Web page address
www.yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)