The aim of this study is determination the effects of humor therapy on fatigue in breast cancer patients undergoing external radiation therapy.
This is a clinical trial study in which 56 breast cancer patients receiving radiation 5 weeks during the treatment will participate. Patients randomly will be assigned into humor therapy and control groups. allocation randomization by bloked randomization will be done. Patients in the experimental group will attend in humor therapy sessions twice a week for a month (a total of 8 sessions). sessions will be held with the three methods; comedy clip, jokes and the fun games. Fatigue questionnaires will be completed each week. The control group will be received routine care.If this study is significant, laughter therapy is a useful step in reducing fatigue and improving the quality of life of cancer patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052313441N1
Registration date:2014-01-09, 1392/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-09, 1392/10/19
Registrant information
Name
Fateme Borzoee
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 571446070
Email address
borzoee75026@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-03-30, 1393/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of humor therapy on fatigue in breast cancer patients undergoing external radiation therapy
Public title
effect of humor therapy on fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included female gender; radiation dose during treatment; 60-50 Gy (6000-5000 rad), cancer stage 0-III; aged 70-18 years; breast surgery history; compeletion of chemotherapy over at least two weeks; treatment administered during radiation therapy for at least 5 weeks and within a week of radiation therapy; hemoglobin greater than 8.
Exclusion criteria included patients with a mental disorder or disease characterized by fatigue(multiple sclerosis; fibromyalgia; AIDS; rheumatoid arthritis).
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Sabzevar University of Medical Sciences
Street address
next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
medsab.Rec.92.5
Health conditions studied
1
Description of health condition studied
breast cancer patients with fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
Primary outcomes
1
Description
fatigue
Timepoint
every week for 5 weeks
Method of measurement
FSI questionnarie
Secondary outcomes
empty
Intervention groups
1
Description
The control group will receive usual care.
Category
N/A
2
Description
humor therapy is a type of Complementary and alternative treatments. Three methods of treatment in the intervention group are comedy clips, fun games with awards and jokes, each session will be lasted 60 minutes twice a week for 4 weeks. Sessions led by researcher and runs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiation and Oncology Center of Reza (AS)
Full name of responsible person
Dr Fateme varshooyi
Street address
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Tadayonfar
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Scinces
Full name of responsible person
Fateme Borzoee
Position
Senior nursing student
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 1523 8420
Fax
Email
borzoee75026@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty member of Sabzevar University
Full name of responsible person
Mostafa Rad
Position
PhD Student of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 571446070
Fax
Email
mostafarad633@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)