1)Objective: To determine the effect of training exercise and nutrition on the severity of fatigue caused by cancer in adolescents who are undergoing chemotherapy in the oncology department of Amir hospital in shiraz , Iran between2015/16. 2)Design: This randomized clinical trial is not blind. 3) Methodology: 110 adolescents' patients between the age of 10 to 18 years are eligible for inclusion in this study and are randomly divided into groups of control and test. The control group filled out a questionnaire before the study about fatigue, but does not receive any training. In the test group they filled out a questionnaire before the study on the subject of fatigue but they received 6 weeks of training and diet. They are told to exercise at home for 20 minutes daily. A week after the end of training both groups filled out the questionnaire of fatigue once again. 4) Study samples : the study samples includes cancer patients who are undergoing chemotherapy. The main condition for entry and withdrawal of participants are; The main criteria for inclusion: Age between 10 to 18 years of age, at least a month has pased from the onset of diagnosis, have not history of heart disease, diabetes, underlying or congenital disease; The main exclusion criteria: lack of desire to continue cooperation, patients who have an amputee, patients who are neurologically impaired due to disease or treatment complications. 5) Intervention: in both groups before the study they completed a questionnaire and the test group is given exercise and nutrition training for six weeks, both groups filled out the questionnaire and fatigue severity is checked. 6) The main outcomes: Fatigue severity caused by cancer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406168124N3
Registration date:2016-04-08, 1395/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Zahra Molazem
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
molazem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-02-13, 1394/11/24
Expected recruitment end date
2016-05-14, 1395/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise and nutrition educational program on severity of fatigue in adolescents' cancer patients undergoing chemotherapy
Public title
The effect of exercise and nutrition educational program on severity of fatigue in adolescents' cancer patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who are undergoing chemotherapy؛ in age range of 10 to 18 years old؛ Duration of illness is at least a month from the onset of diagnosis؛ Willingness to participate؛ physical ability؛ Havinge not participated in similar study؛ having no history of heart failure, diabetes, Underlying and congenital disease. Exclusion criteria: Lack of willingness to cooperate in the research؛ not being present in a meeting of the pre-test and or post-test؛ Lack of participatione in a theoretical or practical training sessions؛ patients who have a physical amputation؛ patients who are ill or the effects of treatment creates a neurological disorders.
Age
From 10 years old to 18 years old
Gender
Both
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
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 Street, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.179
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.0
ICD-10 code description
Malignant neoplasm without specification of site
Primary outcomes
1
Description
fatigue
Timepoint
Before and after the intervention
Method of measurement
Fatigue severity scale questionnaire MFI
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group they are given exercise and diet training.
Category
Other
2
Description
In the control group no training is given.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Hospital Amir
Full name of responsible person
Zahra Keshtkar
Street address
Station 11, Culture City, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Sayed Basir Hashemi
Street address
Zand Street, Shiraz
City
Shiraz
Grant name
94/484203
Grant code / Reference number
94-7643
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
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
School of Nursing Hazrat Fatima(sa), Shiraz University of Medical Sciences