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Effect of Problem Solving Skills Training on Self Efficacy and Self-Concept of Adolescent with Cancer

Protocol summary

Study aim
The purpose of this study is to improve the self-efficacy and self-concept of adolescents through teaching problem solving skills, which will lead to increased adaptability and quality of life.
Design
Clinical trial with control group based on adolescents with cancer, with parallel groups, without blindness, randomized by blocking, and a sample size of 60 patients who needed one month after the start of time and then one month later follow up be
Settings and conduct
The field of this research is a way to deal with problems, thus promoting self-efficacy and self-concept, which, as a result, promotes mental health. The place is Dr. Sheikh Hospital in Mashhad. The study is also done in seven individual sessions per hour.
Participants/Inclusion and exclusion criteria
Entry requirements: All adolescents with cancer who are between the ages of 15 and 12 are resident in Mashhad Non-arrival conditions: If the teenager has entered a big stress within six months If admitted to the ICU. Not educated
Intervention groups
The intervention used in this study is teaching problem solving method to adolescents with cancer, which is one of the cognitive-behavioral methods. So far, this method has been used for anxiety and depression in cancer patients. In the control group, routine care provided by the family or hospital is considered, and no interventions are performed.
Main outcome variables
Improve self-efficacy and self-concept Compatible upgrade as a result of having the best deal in dealing with problems Promoting quality of life as a result of promoting compliance Mental health promotion Reducing impulsive or avoidable behaviors in dealing with problems Increase positive orientation towards problems Participation in the community more actively

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180215038739N1
Registration date: 2018-09-08, 1397/06/17
Registration timing: registered_while_recruiting

Last update: 2018-09-08, 1397/06/17
Update count: 0
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Ali Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3251 6545
Email address
asgaria951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-05, 1397/06/14
Expected recruitment end date
2019-01-04, 1397/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Problem Solving Skills Training on Self Efficacy and Self-Concept of Adolescent with Cancer
Public title
Effect of Problem Solving Skills Training on Self Efficacy and Self-Concept of Adolescent with Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Completion of a therapeutic phase (chemotherapy, radiotherapy and surgery). The goal is only to engage the child with cancer and to make the situation more tangible for the adolescent• . Age between 11-15 Lack of cognitive and behavioral disorders caused by treatments (based on questions from adolescents and their parents) Minimum elementary education level Full family (having parents) Not having a stress like the death of one of the loved ones in the past six months Lack of admission to the intensive care unit The desire and motivation to participate in this course and research Resident of Mashhad Inform the teen about his illness (cancer)
Exclusion criteria:
• The unwillingness of the adolescent or his family to continue attending the course•• If the adolescent enters a large stress If you are experienced bad medical condition or complication during the study
Age
From 11 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, adolescents are grouped according to type of cancer, treatment, duration of Getting Cancer and treatments, and then assigned to the intervention or control group by flip the coin
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad- cross of Doctora- Mashhad Nursing Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-07-16, 1397/04/25
Ethics committee reference number
IR.MUMS.REC.1397.105

Health conditions studied

1

Description of health condition studied
Psychological support for teens with cancer
ICD-10 code
F09
ICD-10 code description
Unspecified mental disorder due to known physiological condition

Primary outcomes

1

Description
Self-efficacy score in the muris questionnaire. Self-concept score in Piers-Harris questionnaire.
Timepoint
At the beginning of the study, at the end of the study and one month after the completion of the study
Method of measurement
Self-efficacy in the muris questionnaire. Self-concept in Piers-Harris questionnaire.

Secondary outcomes

1

Description
Score questionnaire for coping with stress (Lazarus and Folk man)
Timepoint
At the beginning and the end of the study and one month after the completion of the study
Method of measurement
Questionnaire on coping strategies with stress (Lazarus and Folk man)

Intervention groups

1

Description
Intervention group: This study has only one intervention group, which is adolescents with cancer, which holds seven individual sessions of a one-hour problem solving session each week for two sessions. All tutorials are based on the problem solving method of D"zurrilla and nezu, In the end, self-efficacy and self-concept variables are also measured.
Category
Behavior

2

Description
Control group: This study has a control group that is also adolescents with cancer, but there is no intervention from the researcher, and only the routine hospital care for them will be carried out and they must be committed within Study activities outside the routine care of the hospital and inform them if they need to leave the study, In the end, self-efficacy and self-concept variables are also measured.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
ِDr Sheikh Hospital
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
School of Nursing, Ebne Sina Str
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3251 6545
Email
asgaria951@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street. Ghoreishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Askari
Position
Ms.C Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing, Ebne Sina Str
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3251 6545
Email
askariali366@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Askari
Position
Ms.C Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nusing, Ebne Sina Str, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3251 6545
Email
askariali366@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Askari
Position
Ms.C Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nusing, Ebne Sina Str
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3251 6545
Email
askariali366@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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