Protocol summary

Summary
Current research intended to study The efficacy of cognitive rehabilitation of executive function on quality of life and hope in adolescent survivors of Leukemia .This is a quasi-experimental design with a pretest؛ post-test؛ follow up and control group. So؛ adolescent survivors of Leukemia who have medical records in Mofid Children Hospital will be identified and if there is an inclusion and exclusion criteria؛ they will be invited to participate in the research. After obtaining informed consent from participants. The assessment of executive functioning was tested to measuring impairment in executive functions؛ quality of life and hope was tested with the behavioral problem check list in order to recognize the effective issues on executive functions and determining inclusion and exclusion criteria with 4 subtest of Wechsler؛ to control the intelligence of participants are performing. Then individuals will be allocated in two groups of 15 survivor in experimental and 15 survivor in control randomly with table of random. And the experimental group will receive 12 sessions of progressive cognitive executive functioning rehabilitation with cognitive rehabilitation software. The group control will not receive any treatment in this period of time. Before and after intervention and one month after the intervention both group will be assessed with cognitive and quality of life and hope tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051122224N1
Registration date: 2015-10-18, 1394/07/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-18, 1394/07/26
Registrant information
Name
Omid Amani
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 937 289 7485
Email address
o.amani@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences and Health Services
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cognitive rehabilitation of executive function on quality of life and hope in adolescent survivors of Leukemia
Public title
The efficacy of cognitive rehabilitation of executive function on adolescent survivors of Leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children of age-range 12-16 year؛ being diagnosed with Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia with at least 6 months after completion of therapy with no other chronic health conditions during the intervention؛ not having any psychiatric problems or disorders affecting on cognitive functioning؛ the ability to read and write؛ having at least one weakness in cognitive functioning with standard deviation؛ filling out the informed consent of research. Exclusion criteria: having any psychiatric problem or disorder؛ having a history of cancer in first degree relatives؛ lack of consent to participate in the research.
Age
From 12 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
individuals will be allocated in two groups of 15 survivor in experimental and 15 survivor in control randomly with table of random.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences and Health Services
Street address
Ayatalaah Taleghani Hospital؛ Arabi avenue؛ Chamran Highway؛ Tehran
City
Tehran
Postal code
1985717443
Approval date
2015-09-06, 1394/06/15
Ethics committee reference number
SBMU.RAM.REC.1394.165.IR

Health conditions studied

1

Description of health condition studied
Leukemia
ICD-10 code
C91.0, C92
ICD-10 code description
This code should only be used for T-cell and B-cell precursor leukeamia

Primary outcomes

1

Description
Quality of life
Timepoint
pretest؛ post test؛ follow up
Method of measurement
self report Questionnaire

2

Description
hope
Timepoint
pretest؛ post test؛ follow up
Method of measurement
self report Questionnaire

Secondary outcomes

1

Description
executive function
Timepoint
pretest؛ post test؛ follow up
Method of measurement
Camputer Software

Intervention groups

1

Description
Intervention group: Rehabilitation of executive functions will be performed with cognitive rehabilitation program Neurocognitive Joyfull Attentive Training Implement(NJATI). Nejati's program is designed in order to improving executive functioning in patients with brain injury؛ aphasia؛ and dyslexia by Nejati(2013) and it has a good effect on executive functions؛ this program is containing a group of hierarchical organized assignment which is improving all dimensions of attention(selective؛ sustained؛ alternating؛ dividing). In this program experimental group will receive 12 session of 45 minutes.
Category
Treatment - Other

2

Description
control group: will not receive any therapy.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid children's Hospital
Full name of responsible person
Omid Amani
Street address
Mofid children's Hospital؛ Shariati Street؛ Tehran؛ Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Rezaee Tavirani
Street address
Department of Pediatric Radiology؛ Mofid Children's Hospital؛ Ershad masque؛ Shariaty street؛ Tehran
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 of Shahid Beheshti 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
Shahid Beheshti University
Full name of responsible person
Omid Amani
Position
Master Student
Other areas of specialty/work
Street address
Shahid Beheshti University؛ Evin؛ Iran
City
Tehran
Postal code
1983963113
Phone
+98 21 2990 5309
Fax
Email
o.amani@Mail.sbu.ac.ir
Web page address
sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Omid Amani
Position
Master student
Other areas of specialty/work
Street address
Shahid Beheshti University؛ Evin؛ Tehran؛ Iran
City
Tehran
Postal code
1983963113
Phone
00219829905309
Fax
Email
o.amani@Mail.sbu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Omid Amani
Position
Master Student
Other areas of specialty/work
Street address
Shahid Beheshti Univercity؛ Evin؛ Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2990 5309
Fax
Email
o.amani@Mail.sbu.ac.ir
Web page address
sbu.ac.ir

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
Loading...