Determination of the impact of a health literacy improvement program on health literacy and death anxiety in women with breast cancer
Design
This randomized clinical trial has two group, control and intervention. The sample size is 66 persons with parallel and non-blind design
Settings and conduct
This study was conducted in Isfahan's Seyed al-Shohada Hospital on women with breast cancer referring to this hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Had breast cancer with doctor's approval
Being in treated as an outpatient or hospitalized
Awareness of the diagnosis
The duration of the diagnosis of the disease is up to six months
Age over 18 years
Have reading and writing skills
Tendency to cooperate
Didn't have any related health promotion training
Didn't have any disease in metastatic stage
Exclusion criteria:
Not to cooperate
Incompleted questionnaire
Death
Don't attending for more than 2 sessions in the training program
Intervention groups
The training program consists of 4 sessions, twice a week. The time of each session is 45-60 minutes. After the end of the workshops, a one-day group workshop will be held. The feedback-based approach, the statement sheet and pictures used to patient's training . The intervention's end is on a month after the follow up times.
The control group persons have had a training session by giveing them an educational pamphlet.
The questionnaires will be completed in 3 stages: before the intervention, the end of the intervention and a month after the end of the intervention
Main outcome variables
Health literacy; Death Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180506039541N1
Registration date:2018-06-22, 1397/04/01
Registration timing:registered_while_recruiting
Last update:2018-06-22, 1397/04/01
Update count:0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
Marjan Aboudzadeh Behbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3670 2463
Email address
m.aboudzadeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey on the effect of a health literacy promotion program on health literacy and death anxiety in women with breast cancer
Public title
Improving health literacy on health literacy and death anxiety in breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Had breast cancer with doctor's approval
Being in treated as an outpatient or hospitalized
Awareness of the diagnosis
The duration of the diagnosis of the disease is up to six months
Age over 18 years
Have reading and writing skills
Tendency to cooperate
Didn't have any related health promotion training
Didn't have any disease in metastatic stage
Exclusion criteria:
Not to cooperate
Incompleted questionnaire
Death
Don't attending for more than 2 sessions in the training program
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
66
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We using cards on which letters A and B are written. The researcher selects one of the packets containing letters A or B randomly for each of the patients who are eligible to enter the study.Card A is for the intervention group and B to allocate to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
The patients do not know their allocation in the intervention or control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib St., Faculty of Nursing and Midwifery., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.MUI.REC.1396.3.705
Health conditions studied
1
Description of health condition studied
Health literacy
ICD-10 code
Z55
ICD-10 code description
Problems related to education and literacy
2
Description of health condition studied
Death anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Health literacy Level
Timepoint
At the beginning of the study, the end of the intervention, a month after the end of the intervention
Method of measurement
Health literacy questionnaire in Iranian women with breast cancer
2
Description
Death anxiety
Timepoint
At the beginning of the study, the end of the intervention, a month after the end of the intervention
Method of measurement
Templar death anxiety scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The education program consists of 4 sessions, twice a week, which is held in the hospital in the morning shift for each patient. The duration of each session is 60-45 minutes. After that, a group session will be held in the presence of a specialist physician. In addition, the researcher also uses a telenursing program, to improve health literacy.
Category
Rehabilitation
2
Description
Control group: There are no interventions in this group. The questionnaires will be completed in 3 stages: before the intervention, the end of the intervention and a month after the end of the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Al-Shahada Hospital, Isfahan
Full name of responsible person
Masoud Bahrami
Street address
Hezar Jerib St., Department of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Fax
+98 31 3669 9398
Email
bahrami@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Department of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Fax
+98 31 3669 9398
Email
m.aboudzadeh@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Marjan Aboudzadeh Behbahani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
m.aboudzadeh@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Bahrami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar Jerib St., Department of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Bahrami@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marjan Aboudzadeh Behbahani
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezar Jerib St., Department of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
m.aboudzadeh@nm.mui.ac.ir
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
The results of the study will be published in the form of a paper
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The final report of the study is being prepared and the final paper will be published
When the data will become available and for how long
6 Months after the end of study
To whom data/document is available
Researchers and faculty members
Under which criteria data/document could be used
Using the results of the study can be used for future research
From where data/document is obtainable
Masoud Bahrami: Bahrami@nm.mui.ac.ir
Marjan Aboudzadeh: mabodzadeh@yahoo.com
What processes are involved for a request to access data/document
Submitting a request for a master of RCT, approving a research committee at a university, receiving a proposal for a research project, accept or declining demand