The effect of exercise program on depression and fatigue in women with breast cancer undergoing chemotherapy
Design
In this study, 60 patients with breast cancer who are eligible to enter the study will be selected conveniently. Participants will be divided into two groups and each participant will be given a code.
Settings and conduct
This study will be carried out double blinded in the blood section of Imam Reza and Taleghani hospital in Kermanshah city. In this study, the Principal researcher and patients will be kept blinded to place in the intervention and control group.Patients participating in the study are aware, however, than that in the control group or the intervention group were kept blind. Sports exercises will be provided in conjunction with sports physiologists and sports physiotherapists tailored to patients' physical condition, along with slow rhythmic music in the form of film and educational brochures.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gain depression scores less than 20, based on the Beck depression inventory
Exclusion criteria: No history of cancer;Under chemotherapy based on treatment protocols
Intervention groups
The intervention group, observing the film and brochure at home, 72 hours after each chemotherapy session, the exercise will be performd 3 days a week for 30 minutes for 6 weeks.
The control group will not receive any sport intervention
Main outcome variables
Fatigue, Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N86
Registration date:2018-02-17, 1396/11/28
Registration timing:registered_while_recruiting
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness of sport program on depression and fatigue in women with breast cancer under chemotherapy
Public title
Investigation the effectiveness of sport program on depression and fatigue in women with breast cancer under chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of breast cancer at stage 0, 1, 2, 3
Have read and write literacy
Gain depression scores less than 20, based on the Beck depression inventory
Exclusion criteria:
history of cancer
Absence of mental disorders and dementia
Age
From 18 years old to 54 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 consecutive number will be written individually on the sheet and will be placed in a container. The coupled numbers will be assigned to group A (control) and the individual numbers will be assigned into group B (intervention).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the Principal researcher and patients will be kept blinded to place in the intervention and control group.Patients participating in the study are aware, however, than that in the control group or the intervention group were kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
kums.rec.1396.508
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
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
Based on Fatigue Severity Questionnaire (FSS)
2
Description
Depression
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
Beck Depression Inventory (BDI-II)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, observing the film and brochure at home, 72 hours after each chemotherapy session, the exercise will be performd 3 days a week for 30 minutes for 6 weeks.
Category
Behavior
2
Description
The control group will not receive any sport intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Fatemeh Mostafaei
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
fatemeh.mostafaei1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Mostafaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+0988338279899
Email
fatemeh.mostafaei1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Faculty Member of Medical University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+0988338279899
Email
p_abasi2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Mostafaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+0988338279899
Email
fatemeh.mostafaei1369@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Result and main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail