The Effect of Education based on Pender Health Promotion Model on Self-Efficacy and Quality of Life in Patients with leukemia referred to Shiraz medical sciences clinic 2018
Determining the effect of educational intervention based on the Pender Health Promotion Model on self-efficacy and quality of life in patients with leukemia who referred to the clinics of Shiraz University of Medical Sciences in 2018
Design
A clinical trial with a control group, with a parallel group, blind, randomized assignment, a total of 60 qualified candidates entered the study, in which the target population, patients with a history of cancer, aged 18 years and older, between November 2018 and January 2018
Settings and conduct
The study site is an Amir hospital located in the Farhangshahr.The educational program is conducted in four sessions by the researcher and lectures on providing a booklet on leukemia and methods for increasing self-efficacy and quality of life in patients with leukemia based on the components of the Health Promotion Model. The questionnaires will be provided to the samples of both intervention and control groups after the last training session and one month later.
Participants/Inclusion and exclusion criteria
Adult patients (18 years and older) who have leukemia.
Entry Requirements:
o Adult patients (18 years and older) who have leukemia.
o tend to participate in the study.
o Six months from the definitive diagnosis of the disease.
Exit terms:
o Have a history of attending classes on self-efficacy and quality of life.
o Classes have more than one absentee session.
o Patients discontinue the study.
Intervention groups
The training is based on the health promotion model and its impact on the self-efficacy and quality of life of patients with leukemia referred to clinics affiliated to Shiraz University of Medical Sciences is reviewed. Then, the pamphlet control group and educational pamphlets are given.
Main outcome variables
Quality of life and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121208011691N7
Registration date:2018-12-15, 1397/09/24
Registration timing:registered_while_recruiting
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
Fariba Ghodsbin Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
ghodsbin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-21, 1397/07/29
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education based on Pender Health Promotion Model on Self-Efficacy and Quality of Life in Patients with leukemia referred to Shiraz medical sciences clinic 2018
Public title
The Effect of Education based on Pender Health Promotion Model on Self-Efficacy and Quality of Life in Patients with leukemia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (18 years and older) who have leukemia
tend to participate in the study
Six months from the definitive diagnosis of the disease.
Exclusion criteria:
Have a history of attending classes on self-efficacy and quality of life.
Classes have more than one absentee session.
Patients discontinue the study.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to group the samples according to simple random assignment method, 2 cards (A, B) are assigned to each test and control group. Patients, without knowing each group card, can choose one of their two cards And then enter one of the test or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Questionnaires will be collected by a researcher who does not know which intervention group and which one is a controller. Data analysis will be done by the statistics professor who is unfamiliar with both control and intervention groups until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-10-01, 1397/07/09
Ethics committee reference number
IR.SUMS.REC.1397.647
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukaemia
2
Description of health condition studied
leukemia
ICD-10 code
C90
ICD-10 code description
Multiple myeloma and malignant plasma cell neoplasms
3
Description of health condition studied
leukemia
ICD-10 code
C92
ICD-10 code description
Myeloid leukaemia
Primary outcomes
1
Description
Quality of life and self-efficacy
Timepoint
Immediately and a month later
Method of measurement
Quality of life questionnaire and self-efficacy
Secondary outcomes
1
Description
Knowledge
Timepoint
Immediately and 1 months later
Method of measurement
Pender Model Questionnaire
Intervention groups
1
Description
"Intervention group": The intervention group participates in 4 sessions of 2 hours (weekly one session), which is provided by the researcher in lecture, question and answer, and providing a booklet on leukemia and ways to increase self-efficacy and quality of life. In patients with leukemia, it is based on components of the Pender Health Promotion Model. The contents of each training session will be given to the intervention group on the same day and the lesson will be briefed at the beginning of the class. The questionnaires will be provided to the intervention group after the completion of the last training session. One month later, the questionnaires are again filled in to evaluate the educational longevity.
Category
Lifestyle
2
Description
"Control group": The questionnaires will be provided to the control group before the intervention and immediately after the end of the intervention as well as one month after the end of the intervention. In order to observe ethical points after the end of the intervention, the content of the training will be provided to the control group as a training manual.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Seyed Omid Reza Zakavat
Street address
Farhang shahr-Amir Oncology Hospital
City
Shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3732
Fax
+98 71 3632 5655
Email
amirhosp@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Unes Ghasemi
Street address
Zand street, Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 0050
Fax
+98 71 3233 6853
Email
www@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
PhD / faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz, Zand Avenue, Namazi Square, Faculty of Nursing and Midwifery, Hazrat Fatemeh (S)
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
ghodsbin@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
PhD / faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz, Zand street, Namazi Square, Faculty of Nursing and Midwifery, Hazrat Fatemeh (S
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
ghodsbin@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Zeydani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz, Zand street, Namazi Square, Faculty of Nursing and Midwifery, Hazrat Fatemeh (S)
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
maryamzeydani2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD