The effect of energy saving strategies education on fatigue and selfcare efficacy of women with breast cancer receiving chemotherapy in hospitals of the Zahedan University medical sciences in 2019
Determine of effect of Energy Storage Strategies on Fatigue and Career Self-efficacy in Women with Breast Cancer Under Chemotherapy
Design
Type of study is controlled randomized clinical trial, and after explaining the objective of the project and taking the written consent from the qualified patients, the people are selected in accessible manner. The sample volume of this study is 40 people per group. By referring and gradually selecting individuals, a card will assign to them, which will determine the individual group.
Settings and conduct
The target population includes all patient diagnosed with Breast Cancer, who referred to Khatam-al-anbia and Ali-ebn Abi taleb Hospitals of Zahedan in 2019 for chemotherapy, having the entry conditions.
Participants/Inclusion and exclusion criteria
The conditions to enter:
The Age between 20-60
At cancer stage 1 or 2 or 3
Receiving at least a chemotherapy session
Being able to establish relationship or Cooperation
Lack of cardio-pulmonary disease
Lock of known neuropsychiatric disorder and consuming relevant medicines.
Being able to read and write.
The conditions not to enter:
An absent during the training sessions
Lock of executing the training plan for one ongoing week
patient metastasis
Death of patient
Intervention groups
Intervention Group: the strategies of energy saving, which will be conducted in the experimental group within 3 individual session, one per week. After Full filling the 3 training session, they will be followed for 6 weeks. The above-mentioned interval, the questions are distributed to control and intervention group, while the post- test will be taken.
The control group receives no special cars, except rut in cares.
Main outcome variables
Training Energy saving strategies is a methods needs no cost and executable doting daily activities to reduce fatigue and increasing core efficiency of patient.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036675N4
Registration date:2019-01-27, 1397/11/07
Registration timing:prospective
Last update:2019-01-27, 1397/11/07
Update count:0
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Fatemeh Kiani
Name of organization / entity
Faculty member, Zahedan University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
f.kiani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-04-08, 1398/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of energy saving strategies education on fatigue and selfcare efficacy of women with breast cancer receiving chemotherapy in hospitals of the Zahedan University medical sciences in 2019
Public title
Effect of energy saving strategies education on fatigue and selfcare efficacy of women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The Age between 20-60
being at 1 or 2 or 3 cancer stage
Receiving at least one session chemotherapy
Being able to establish relationship or cooperation.
Lack of cardio-pulmonary disease.
Lock of known neuropsychiatric disorder and consuming relevant medicines.
Being able to read and write
Exclusion criteria:
An absent during the training sessions
Lock of executing the training plan for one ongoing week
patient metastasis
Death of patient
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will refer to the chemotherapy wards of Ali ibn Abi Talib (PBUH) and Khatam al-Anbia (PBUH) hospitals after approving the proposal and obtaining university permissions and performing the necessary coordination. Then, intervention and control groups will be gradually selected. After explaining the purpose of the project and obtaining written consent from eligible patients, individuals are selected in a non-random and accessible manner. To allocate randomness, first, the total number of envelopes containing the groups arranged and randomly sorted. By referring and gradually selecting individuals, one of these cards will be assigned, which will determine the individual group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.ZAUMS.REC.1397.392
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Fatigue of breast cancer patient
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Multidimensional Fatigue Inventory
2
Description
Self-efficacy of breast cancer patient
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Strategies Used By People to Promote Health Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: the strategies of energy saving, which will be conducted in the experimental group within 3 individual sessions, one per week. After Full filling the sessions, they will be followed for 6 weeks.
Category
Behavior
2
Description
Control group: The control group, except for routine care, does not receive special care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Fatemeh Kiani
Street address
Zahedan, Jam-e-jam Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 6269
Fax
Email
khatamhospital-zah@yahoo.com
Web page address
http://zaums.ac.ir
2
Recruitment center
Name of recruitment center
Ali ibn abi taleb hospital
Full name of responsible person
Fatemeh Kiani
Street address
Persian gulf highway, Salamat Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
drkazemmomeni@gmail.com
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Deputy of Research and Technology, Medical Sciences Campus, Dr.Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Kiani
Position
Instructor, faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Factulty of nursing and midwifery, Mashahir sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
f.kiani@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Kiani
Position
Instructor, faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mashahir sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
f.kiani@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Kiani
Position
Instructor, faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
faculty of nursing and midwifery, Mashahir sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
f.kiani@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
only the main outcome data will be available
When the data will become available and for how long
After publishing the article in 2019
To whom data/document is available
all people
Under which criteria data/document could be used
Improve treatment conditions
From where data/document is obtainable
Zahedan University of Medical Sciences
What processes are involved for a request to access data/document