Protocol summary

Study aim
The aim of this study was to investigate the effectiveness of two methods of intervention, cognitive rehabilitation and memory and attention adaptation, and compare their effectiveness on working memory, processing speed, attention and executive functions in children Survived from cancer.
Design
Clinical trials have two experimental groups and one control group, with parallel, randomized groups, on 60 subjects. To assign subjects, a random matching method is used. Subjects are individually matched and paired by age and gender. Each of the two was assigned with a number and then with simple random method, one of the numbers assigned to experimental group and the other number assigned to control group.
Settings and conduct
The interventions were performed individually by a child and adolescent psychologist in َAban psychological clinic; Located in Shiraz; Fars province.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 6 to 16 years old; suffering from Acute lymphoblastic leukemia with the history of chemotherapy; passing at least 2 months from the end of medical treatment; Weakness with at least one standard deviation in research variables; Conscious satisfaction to participate in research. Non-inclusion criteria: suffering from other kinds of cancer; with the history of other kinds of medical treatment.
Intervention groups
This study include 3 groups. First experimental group receive cognitive rehabilitation training. The second experimental group receive memory and attention adaptation training; and the 3th group, as the control group, do not receive any intervention during the study.
Main outcome variables
Scores of memory; attention; processing speed and executive functions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200516047463N1
Registration date: 2020-06-14, 1399/03/25
Registration timing: prospective

Last update: 2020-06-14, 1399/03/25
Update count: 0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Nafiseh Damreihani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 71 3833 4383
Email address
nfsh.reyhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Cognitive Rehabilitation Training and Memory and Attention Adaptation Training on Working memory, Attention, Processing Speed and Executive Function in Children Survived from Cancer
Public title
Effectiveness of Rehabilitation on Memory in Children Survived from Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 to 16 years old Having a diagnosis of acute lymphoblastic leukemia With the history of chemotherapy Weakness with at least one standard deviation in research variables Satisfaction with participating in research
Exclusion criteria:
Suffering from other kinds of cancer Using of combined medical treatment methods (chemotherapy along with radiation therapy) Other chronic physical illnesses
Age
From 6 years old to 16 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
To assign subjects, a random matching method is used. Subjects are personally matched and paired by age and gender. Each of the two was assigned with a number and then with simple random method, one of the numbers assigned to experimental group and the other number assigned to control group.
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
Ethics committe of Islamic Azad University- Shiraz Branch
Street address
No.7, Karen building, 64/1 lane, Pasdaran boulevard
City
Shiraz
Province
Fars
Postal code
718467773
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1399.002

Health conditions studied

1

Description of health condition studied
Acute lymphoblastic leukemia with a history of chemotherapy
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]

Primary outcomes

1

Description
Score of working memory in Wechsler Intelligence Scale for Children- Fourth Edition
Timepoint
Before the intervention, after the intervention, 2 months after the end of the intervention
Method of measurement
Wechsler Intelligence Scale for Children- Fourth Edition

2

Description
Score of processing speed in Wechsler Intelligence Scale for Children- Fourth Edition
Timepoint
Before the intervention, after the intervention, 2 months after the end of the intervention
Method of measurement
Wechsler Intelligence Scale for Children- Fourth Edition

3

Description
Score of attention in Stroop test
Timepoint
Before the intervention, after the intervention, 2 months after the end of the intervention
Method of measurement
Stroop test

4

Description
Score of executive functions in Behavior Rating Inventory of Executive Function
Timepoint
Before the intervention, after the intervention, 2 months after the end of the intervention
Method of measurement
Behavior Rating Inventory of Executive Function

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: first group, Cognitive Rehabilitation Training, This training method includes 12 50-minute sessions that are held once a week. The first 20 minutes of the session are devoted to practical cognitive rehabilitation exercises. Exercises such as: time-reducing techniques, content memorization techniques, increasing the field of view using the card, measuring reading speed, visual memory exercises using the card, finding differences and similarities in images with time recording, Memory games such as recalling spoken words or naming objects seen in the picture, auditory memory exercises, etc. Then in the last 30 minutes of the session, the subject will use memory and concentration software to perform visual and auditory memory exercises. In this research, the Persian version of Cogmed software will be used. During each session, the subject should first perform forward visual and auditory exercises and then reverse visual and auditory exercises.
Category
Rehabilitation

2

Description
Intervention group: second group, Memory and Attention Adaptation, This training method includes 4 one-hour face-to-face sessions that are held once every 2 weeks, and 3 phone calls at intervals of each face-to-face session, to follow up on homework and troubleshooting. In the fourth session, relapse prevention methods will be taught to the person and after a few months, a face-to-face session can be requested to review the treatment process. Specific techniques used in this method are drawn from the cognitive-behavior therapy(CBT). Memory and Attention Adaptation Training is organized into four components: (1) education (on chemotherapy related cognitive problems and other influences on attention and memory such as stress); (2) self-awareness training (self-monitoring to identify “at risk” situations or conditions associated with cognitive failure); (3) compensatory cognitive skills training; and (4) applied relaxation training for arousal reduction.
Category
Rehabilitation

3

Description
Control group: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Professional Clinic
Full name of responsible person
Mohammad Reza Bordbar
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7000
Email
bordbarm@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sareh Behzadipour
Street address
No.7, Karen building, 64/1 lane, Pasdaran boulevard
City
Shiraz
Province
Fars
Postal code
718497773
Phone
+98 71 3833 4383
Email
nfsh.reyhani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Nafiseh Damreihani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.7, Mahan building, 64/1 lane, Pasdaran boulevard
City
Shiraz
Province
Fars
Postal code
7184967773
Phone
+98 71 3833 4383
Fax
Email
nfsh.reyhani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nafiseh Damreihani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.7, Mahan building, 64/1 lane, Pasdaran boulevard
City
Shiraz
Province
Fars
Postal code
7184967773
Phone
+98 71 3833 4383
Fax
Email
nfsh.reyhani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nafiseh Damreihani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.7, Mahan building, 64/1 lane, Pasdaran boulevard
City
Shiraz
Province
Fars
Postal code
7184967773
Phone
+98 71 3833 4383
Fax
Email
nfsh.reyhani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Questionnaires completed in the pre-test, post-test and follow-up stages can be provided
When the data will become available and for how long
access period after printing the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
In order to verify the results
From where data/document is obtainable
nfsh.reyhani@gmail.com
What processes are involved for a request to access data/document
The proposal of the research project should be sent along with the request for access to the data
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