Background: Educational intervention can be effective in improvement of quality of life. The present study aimed to investigate the effect of educational intervention based on Pender's theory on quality of life of patients 6 months after mastectomy.
Methods: This randomized pre/posttest clinical trial is conducted in Motahari polyclinic affiliated to Shiraz University of Medical Sciences, Shiraz, Iran. The patients are randomly divided in to an intervention (n=70) and a control group (n=70). Both groups are assessed regarding different aspects of quality of life using EORTC QLQ-C30 questionnaire, which consists of 30 questions, at different phases (pretest and posttest). The interventional group are participated in an educational program for 2 months, while the control group only received the polyclinic's routine care. The interventional group is invited to participate in educational intervention in five group of 10 to 15 persons. Educational intervention consisted of three45t060 miniutes sessions about patients present illness and nutrition , physical activity and methods of stress management.To enhance the effect of intervention the interventional group is asked with self monitoring by using Pender's quastionare in three aspects such as physical activity , nutrition and stress management. They are asked to report their life aspects by using on the above mentioned questions one researcher is responsible to monitor their reports once every two weeks.
General information
Acronym
--
IRCT registration information
IRCT registration number:IRCT138806172432N1
Registration date:2016-06-27, 1395/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Azadeh Amiri
Name of organization / entity
Shiraz University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
amiriea@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellorfor research of Shiraz University of Medical Sciences
Expected recruitment start date
2008-07-20, 1387/04/30
Expected recruitment end date
2008-09-20, 1387/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of an Educational Intervention based on Pender's Theory on Quality of Life of Breast Cancer Patients after Mastectomy Surgery
Public title
The Effect of an Educational Intervention on Quality of Life after Mastectomy Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :aging 25-55 years, passage of 6 months from mastectomy surgery, and not suffering from lymphedema and other malignancies. Exclusion criteria:recurrence of the disease and metastasis to other organs.chemoterapy or radiotrrapy
Age
From 25 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random number table
Secondary Ids
1
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences, Shiraz, Iran
Street address
School of Nursing and Midwifery
City
Shiraz
Postal code
7193613119
Approval date
2008-05-10, 1387/02/21
Ethics committee reference number
87-4018
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
c50.9
ICD-10 code description
Malignant Neoplasm OFBreast -Breast Unspecified Mass
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention and two mounths after intervention
Method of measurement
QLQ-C30 Quastionaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Interventional group:
The interventional program is carried out through 3 training45 to 60 miniutes sessions in three fields of nutrition, physical activity, and stress management. Thus, the intervention group participants take part in the training program in groups of10 to 15, so that group discussion forums become possible. The educational content included information about the disease, its treatment and complications, diet including healthy nutrition for the treatment process, and recovery including healthy food pyramid and foods that are essential for good health. High-risk foods and their low-risk alternatives in the course of treatment are expressed, as well. In addition, healthy cooking method of different food products is emphasized and necessary training is conducted in this area. Also, sports activities, including healthy physical activity pyramid, were emphasized in order to increase mobility at work and home in everyday life. Recommendations are, too, made about performing the activities that the patients can do. Besides, rehabilitation and recovery exercises, including stretching, isotonic, and isometric exercises, are taught to improve shoulder, scapula, and motor muscles movement in the process of treatment and recovery. Moreover, the patients are trained about and are required to do stress reduction and relaxation techniques, such as diaphragmatic breathing, imagination, and positive thinking, every day. They are also provided with the necessary supports in different fields of the intervention. Furthermore, an educational booklet is prepared and given to the patients.
During the study period, the researchers followes the patients by phone calls and ensured about their self-monitoring. In case the patients need assistance about other problems, they are trained individually or, if necessary, are referred to a specialist.
Category
Lifestyle
2
Description
Control group: control group just will received the routine care of polyclinic.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari polyclinic affiliated to Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Azade Amiri
Street address
Namazee Square ,Zand Street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research ofShiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Dr Basir Hashemi
Street address
Zand Street, Shiraz University of Medical Sciences, Shiraz
City
Shiraz
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 ofShiraz University of Medical Sciences, Shiraz, Iran
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
School Of Nursing and Midwifery Of Shiraz University of Medical Sciences,
Full name of responsible person
Azadeh Amiri
Position
Master of Science In Nursing -Faculty member of School of Nursing and Midwifery, Shiraz University o
Other areas of specialty/work
Street address
Namazee Square, Zand Street, Hazrate Fateme School Of Nursing and Midwifery, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
amiriea@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Marzieh Moattari
Position
Full Prfessor of Nursing Education
Other areas of specialty/work
Street address
Namazee Square, Zand Street, Hazrate Fateme School Of Nursing and Midwifery, Shiraz
City
Shiraz
Postal code
: 7193613119
Phone
+98 71 3647 4252
Fax
+98 71 3647 4252
Email
moattar@yahoo.commoattari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Azadeh Amiri
Position
Master of Science In Nursing -Faculty member ofSchool of Nursing and Midwifery, Shiraz University of
Other areas of specialty/work
Street address
Namazee Square, Zand Street,Hazrate Fateme School Of Nursing and Midwifery, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
amiriea@sums.ac.irAzadehAmiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)