Determining the Effect of Combined Learning on the ability of caregivers of Cancer Patients Under Chemotherapy Referring to Clinics
Design
Participants are randomly divided into intervention and control groups and each participant is assigned a code
Settings and conduct
This clinical trial is blinded and conducted in Shiraz chemotherapy centers in such a way that six sessions of the training class will be held for the intervention group and will not be conducted for interventional control group.
Participants/Inclusion and exclusion criteria
The conditions for entry into this study are not personnel of the health team and the program and the training class have not passed the care of the cancer patient and the conditions for withdrawal from this study are excluded from the questionnaire that are not completely completed and the reluctance to continue cooperation during the study They have the right to leave
Intervention groups
For the intervention group, six sessions of the class will be held and will not intervene for the intervention group
Main outcome variables
Health Knowledge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160404027216N9
Registration date:2019-01-26, 1397/11/06
Registration timing:retrospective
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Fatemeh Vizeshfar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4258
Email address
vizeshfarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-01-04, 1397/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using combination learning on the empowerment of caretakers of cancer patient under chemotherapy referred to clinics
Public title
Use Combination Learning
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years.
Nationality is Iranian
Be able to speak Persian or read Persian and understand it
Do not hurt the health personnel
The program and the training course on caring for a cancer patient have not been passed
Do not have hearing, vision or speech problems.
Exclusion criteria:
Questionnaires that are not completely completed are deleted.
Unwillingness to continue working during the study
If you have more than one absentee session, you will be dropped out of the classroom
If a person's psychological disorders develop, he or she will be excluded from the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The centers of chemotherapy are randomly assigned to the centers. Subsequently, the samples are determined individually
Blinding (investigator's opinion)
Double blinded
Blinding description
En Since the questionnaire is given to all participants, no one is aware of being in the control and intervention group. The person who analyzes the information is also unaware of who is in the intervention and 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences,opposite Phalestine Street, Zand Blvd,
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.SUMS.REC.1397.703
Health conditions studied
1
Description of health condition studied
The ability of caregivers of cancer patients
ICD-10 code
Z55.8
ICD-10 code description
Other problems related to education and literacy
Primary outcomes
1
Description
The ability of carers for cancer patients
Timepoint
Pre- intervention, post- intervention and one month after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group: training materials on the common side effects of chemotherapy and how to deal with them are given face-to-face training, and at the end of the training CD containing the same The materials are for home use.
Category
Other
2
Description
The intervention group is two: The training about the common complications of chemotherapy and how to deal with them is only done in the form of a training CD and not face-to-face training.
Category
Other
3
Description
Control group: There is no training in the control group and, at the end, to comply with the ethical requirements of the CD Is given to people.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chemotherapy centers
Full name of responsible person
Nahid Karimi
Street address
School of Nursing and Midwifery,Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4252
Email
nahid.karimiii72@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
School of Nursing and Midwifery,Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
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
Nahid Karimi
Position
Bachelore
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery,Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
nahid.karimiii72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Vizeshfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery,Shiraz,Iran
City
shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
vizeshfarf@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nahid Karimi
Position
Bachelor of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery,Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
nahid.karimiii72@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
Not applicable
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 domestic and foreign publications and present in credible 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
Nahid Karimi
What processes are involved for a request to access data/document