The Effects of Education Based on Planned Behavioral Model on Perceived Self-efficacy and Social Support on Hematologic Malignancy Patients After Hematopoietic Stem Cell Transplantation
The Effect of Education Based on the Planned Behavioral Model on Self-efficacy and Perceived Social Support of Cancer Patients with Hematopoietic Stem Cell Transplant Referred to Motahari Clinic in Shiraz, 1397
Design
In this research, 66 cancer patients are selected after hematopoietic stem cell transplantation with inclusion criteria. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This is a one-blind clinical trial that will be carried out At Motahhari clinic in Shiraz ,In this way, for the intervention group, 2 face-to-face and individual face-to-face training sessions will be held and will not be conducted for the intervention group.
Participants/Inclusion and exclusion criteria
The conditions for entering this study are over 18 years of age, Iranian nationality, and the ability to speak Persian or read Persian and understand it. Is not part of the health team personnel, they have not completed the program and classroom on post-transplantation hematopoietic stem cell transplantation, and the conditions of non-attendance of the participant are not auditory, visual or speech problems, have no known mental disorders, complete questionnaires They are not completed and they are not suffering from any other chronic illness, except for cancer.
Intervention groups
For the intervention group, 2 face-to-face and individual face-to-face training sessions will be held. There will be no interventional intervention for the intervention group.
Main outcome variables
Health knoweledge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180806040715N1
Registration date:2018-11-03, 1397/08/12
Registration timing:registered_while_recruiting
Last update:2018-11-03, 1397/08/12
Update count:0
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
zahra keshtkaran
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5233 7546
Email address
zkeshtkar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Education Based on Planned Behavioral Model on Perceived Self-efficacy and Social Support on Hematologic Malignancy Patients After Hematopoietic Stem Cell Transplantation
Public title
The Effects of Education Based on Planned Behavioral Model on Hematologic Malignancy Patients After Hematopoietic stem cell transplant
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Iranian nationality
Be able to speak Persian and read Persian and understand it
Not a member of the health team staff
The program and the training course for post-bone marrow transplantation have not been completed
Exclusion criteria:
Have hearing, visual or verbal problems
Have known psychiatric disorders
Absolutely incomplete questionnaires will be deleted
Have other chronic conditions other than cancer
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning samples to the test and control groups is based on the randomized block method using a randomized table, which is a group with the letter A and the other group with the letters B (in this study, group A Control and intervention group B).
In this way, our blocks are two-dimensional and we consider the different patches of these two letters, which include AB and BA. We assign one to the crash of 1 and the other to 2, and each time a random number is selected, and the corresponding pattern of that number determines the order of placing individuals in the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the questionnaire is given to all participants, no one is aware of being in the control and intervention group. An individual analyzing information is also unaware of who controls and intervenes.
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 Blvd, Central Building of Shiraz University of Medical Sciences, Shirazs University
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-12-28, 1397/10/07
Ethics committee reference number
IR.SUMS.REC.1397.602
Health conditions studied
1
Description of health condition studied
Evaluating the effectiveness of education based on planned behavior model on cancer patients
ICD-10 code
Z55
ICD-10 code description
Problems related to education and literacy
Primary outcomes
1
Description
Self-efficacy and perceived social support and health knowledge
Timepoint
Before intervention ,immediately after intervention, one month after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group: the implementation of 2 sessions of the face-to-face and individual face-to-face class
Category
Other
2
Description
In the control group there is no intervention and at the end of the work the materials will be provided as a booklet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari clinic
Full name of responsible person
mahboobeh kazempour
Street address
Namazi square, Nursing and midwifery, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4258
Email
mahboobk60@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
seyed basir hashemi
Street address
Zand Blvd, Central building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
Vcrdep@sums.ac.ir
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
mahboobeh kazempour
Position
Bachelore
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square, Nursing and Midwifery school, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4258
Email
mahboobk60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra keshtkaran
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazah Square, Nursing and Midwifery school, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4258
Email
zkeshtkar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mahboobeh kazempour
Position
Bachelor of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazah Square, Nursing and Midwifery school, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4258
Email
mahboobk60@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
Due to the confidentiality of the data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Publish in various domestic and foreign publications and present at valid seminars
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
research team members
Under which criteria data/document could be used
As statistical information in research such as meta-analysis, which requires these data.
From where data/document is obtainable
mahboobeh kazempour
What processes are involved for a request to access data/document