Protocol summary

Summary
Present study will aim to determine the effectiveness of life skills training on various aspects of mental health and academic achievement in adolescents with cancer in 2016. This study will be a before and after with control group that will perform on 120 teenagers with cancer in Iran. The samples will randomly divided into two groups; experimental group (n = 60) and control group (n = 60). Inclusion criteria include; age 9 through 18 years, being student, a definitive diagnosis of cancer, the same grade of cancer, spent at least 6 months after definitive diagnosis, failure to participate in similar training programs, lack of other chronic diseases. Absence from meeting of training (even once), any learning disability and mental retardation will consider as exclusion criteria. In this project, researchers were responsible for the training. For this purpose two methods of training were used: 1. Direct methods include lectures, face to face training, group discussion and the use of clips in training. 2. Indirect methods include educational pamphlets and leaflets. The experimental group received training in 13 educational sessions and term of each educational session was 45 min. During the 13 sessions, the trainer who was an expert woman in clinical psychology performed life skills training in the best way possible. In order to provide comfort for adolescents with cancer, the sessions were held simply and with break time.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050727779N1
Registration date: 2017-01-25, 1395/11/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Mohammad Mehdi Mohammadi
Name of organization / entity
Kermanshah University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 1129
Email address
mm.mohammadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey on Effectiveness of Life Skills Training on Mental Health and educational Achievement of Adolescents with Cancer
Public title
Effectiveness of Life Skills Training on Mental Health and educational Achievement
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included; age 9 through 18 years, being student, a definitive diagnosis of cancer, the same grade of cancer (Partially), spent at least 6 months after definitive diagnosis, failure to participate in similar training programs, lack of other chronic diseases. Absence from meeting of training (even once), any learning disability and mental retardation were considered as exclusion criteria.
Age
From 9 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti street, Building No. 2
City
Kermanshah
Postal code
6719967775
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
KUMS.REC.1395.441

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C79.9
ICD-10 code description
Generalized (secondary)

Primary outcomes

1

Description
Mental health
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
General Health Questionnaire

Secondary outcomes

1

Description
Academic progress
Timepoint
Before the intervention, three months after the intervention.
Method of measurement
Grade point average

Intervention groups

1

Description
Intervention is life skills training. This training will include techniques and life skills, that it will be held for the experimental group in 13 sessions and within 45 minutes.
Category
Lifestyle

2

Description
The control group received no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohammad Kermanshahi hospital
Full name of responsible person
Mohammad Hadi Salahshoor
Street address
Shirin Park, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Mohammadi
Position
MSc in Nursing
Other areas of specialty/work
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
Postal code
6719967775
Phone
+98 918 721 2470
Fax
Email
mehdi20.mohamadi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Soheila Astanegi
Position
MSc in nursing
Other areas of specialty/work
Street address
Building No. 2, Shahid Beheshti street, Kermanshah
City
Kermanshah
Postal code
6719967775
Phone
+98 83 3836 1129
Fax
Email
shima23.parandin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mohammad Mehdi Mohammadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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