Objective: Effectiveness of coping skills training on doughters of mothers who suffers from breast cancer on their quality of life.
Design: Non-random، not blind، controlled phase، double center study.
Study population: Female adolescents (15 :18 years ) of mothers who suffer from breast cancer.
Method: In this study،after obtaining approval from the ethics committee of the university's ethics committee، to collect samples described above. Samples of experimental group have been selected from Imam Khomeini Hospital and samples of the control have been selected from Rasoul Akram Hospital. Teaching materials to experimental group are being thought in 4 session ( 2 hours for each session) while pediatric psychiatrist have been attended in all 4 session.
Control group have not being thought. General Pediatric Quality Of Life questionnaire have been completed before and after intervention in experimental group.
This questionaire have been completed at the base line and 4 weeks later by control group.
Inclusion criteria: they have not chronic disease or cancer، previously unknown as psychological physical and cognitive disorders.
Exclusion criteria: occurrence of stressful events، attendance in specific courses related to subject of our study،not attending in more than one session.
Sample size: 96
Intervention: teaching coping skills during 4 session.
The primary outcome: the effect of coping skills training on quality of life of those girls whose mothers are suffering from breast cancer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102024617N1
Registration date:2015-12-27, 1394/10/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Mina Mianji
Name of organization / entity
Iran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 7536
Email address
mianeji.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coping skills training on quality of life in adolescents daughters of mothers with breast cancer
Public title
The effect of coping skills training on quality of life in adolescents daughters (15 :18 years) of mothers with breast cancer ؛
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: they have not chronic disease or cancer، previously unknown as psychological physical and cognitive disorders.
Exclusion criteria: occurrence of stressful events، attendance in specific courses related to subject of our study،not attending in more than one session.
Age
From 15 years old to 17 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Side of Millad towera، Hemmat highway
City
Tehran
Postal code
Approval date
2015-10-14, 1394/07/22
Ethics committee reference number
IR.IUMS.REC.1394.26577
Health conditions studied
1
Description of health condition studied
pediatric Quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention، 1 month after intervention
Method of measurement
Pediatric Quality of Life Inventory Tm 4.0 Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: coping skills training in 4 session in 2 hours per session
Category
Lifestyle
2
Description
Control group
Not application
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr.Habibolah Mahmoodzadeh
Street address
Imam Khomeini Hospital، End of boulevard Keshavarz، Valiasr Square
City
Tehran
2
Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Dr.Mohamad Jabari
Street address
Niyayesh Street، Shahrara، Satarkhan Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr.Morteza Naserbakht
Street address
Avenue Valiasr، Street Rashid Yasemi، School of Nursing and Midwifery
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Medicine Science University
Full name of responsible person
Mina Mianji
Position
Master of pediatric nursing
Other areas of specialty/work
Street address
Number 6، Hashemi Alley، Monirye Square، Valiasre Street، Tehran
City
Tehran
Postal code
Phone
+98 21 5539 4989
Fax
Email
minamianji88@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of medical Sciences
Full name of responsible person
Dr.Sedighe Khanjari
Position
Phd of nursing
Other areas of specialty/work
Street address
Side of Millad tower،Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
sed.khanjari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of medical sciences
Full name of responsible person
Mina Mianji
Position
Master of pediatric nursing
Other areas of specialty/work
Street address
Number 6، Hashemi Alley، Monirye Square، Valiasre Street، Tehran
City
Tehran
Postal code
Phone
+98 21 5539 4989
Fax
Email
mianeji.m@iums.ac.ir; minamianji88@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)