Protocol summary

Summary
Aim of this study to determine the effect of energy conservation strategies on cancer related fatigue during breast cancer chemotherapy in Urmia in 2014. Inclusion criteria include women with breast cancer undergoing chemotherapy; age 20-60; familiarity with Persian; not having experience stressful events in the last 6 months; not having a mental illness; not having any systemic disease that is known to cause fatigue and exclusion criteria include having another cancer; having Under 20 years of age and over 60 years; unfamiliarity with Persian; having experience stressful events experienced in the last 6 months; having a mental illness; having any systemic disease that is known to cause fatigue. The sample size was 110. Intervention consist of implementation of energy conservation strategies for 6 weeks and determine the effect of this strategies after completion of the intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012520778N1
Registration date: 2015-04-19, 1394/01/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-19, 1394/01/30
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia Medical Science University
Expected recruitment start date
2014-10-21, 1393/07/29
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Energy Conservation Strategies on Cancer-Related Fatigue during breast cancer chemotherapy
Public title
The Effect of Energy Conservation Strategies on Cancer-Related Fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:women with breast cancer undergoing chemotherapy; age 20-60; familiarity with Persian; not having experience stressful events in the last 6 months; not having a mental illness; not having any systemic disease that is known to cause fatigue and exclusion criteria: having another cancer; having Under 20 years of age and over 60 years; unfamiliarity with Persian; having experience stressful events experienced in the last 6 months; having a mental illness; having any systemic disease that is known to cause fatigue
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: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Uromia Medical University
Street address
Uromia Medical University, Setad Markazi, Jahad Ave, Resalat Bolvar
City
Uromia
Postal code
57147734
Approval date
2014-12-01, 1393/09/10
Ethics committee reference number
113685/4/93/6ب

2

Ethics committee
Name of ethics committee
Uromia medical university
Street address
Uromia- resalat bolvar- jahad Ave-
City
Uromia
Postal code
Approval date
2014-12-01, 1393/09/10
Ethics committee reference number
113685/4/93/ب

3

Ethics committee
Name of ethics committee
uromia medical university
Street address
Uromia- resalat bolvar- jahad Ave.- setad markazi - uromia medical university
City
Uromia
Postal code
Approval date
2014-11-05, 1393/08/14
Ethics committee reference number
113685/4/93/ب

Health conditions studied

1

Description of health condition studied
breast cancer patients undergoing chemotherapy
ICD-10 code
C50.0, C50
ICD-10 code description
C50.0 Nipple and areola- C50.1 Central portion of breast -C50.2 Upper-inner quadrant of breast - C50.3 Lower-inner quadrant of breast- C50.4 Upper-outer quadrant of breast - C50.5 Lower-outer quadrant of breast - C50.6 Axillary tail of breast -C50.8 Overl

Primary outcomes

1

Description
fatigue
Timepoint
before and after intervention
Method of measurement
CFS quessionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The control group will not be Individual and group intervention sessions and sending SMS is energy conservation strategies. Energy conewrvation strategies to trains to do the work, consume less energy and use the energy efficiently and store it for important and higher priority affairs. Energy conewrvation strategies to trains to avoid unnecessary work. energy conservation Strategies will be presented in 6 session and the duration of each session will be 1.5 hours. Each group will consist of 10 persons.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational and Therapeutic Center of Omid of Urmia
Full name of responsible person
Atefe Madani
Street address
Farhang Town, Uromia
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia Medical Sience University
Full name of responsible person
Mrs Ghaffarzade
Street address
Urmia; Setad markazi; Jahad Ave; Resalat Bolvar;
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia Medical Sience University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Urmia Medical Sience University
Full name of responsible person
Dr. Fatemeh Moghaddam Tabrizi
Position
Professor of Midwifery
Other areas of specialty/work
Street address
Urmia Medical Sience University, Sero, School of Nursing and Midwifery
City
Urmia
Postal code
Phone
+98 43 3275 4921
Fax
Email
moghaddam.f@umsu.ac.irfmtabrizi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia Medical Sience University
Full name of responsible person
Dr. Fatemeh Moghaddam Tabrizi
Position
Professor of Midwifery
Other areas of specialty/work
Street address
Urmia, Seroo, School of Nursing and Midwifery
City
Urmia
Postal code
Phone
+98 43 3275 4921
Fax
Email
fmtabrizi@gmail.commoghaddam.f@umsu.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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