Evaluation of applicability and feasibility and the effectiveness of acceptance and commitment therapy on quality of life and psychological flexibility of adolescent survivors with cancer experience
Investigating the feasibility and effect of ACT treatment on acceptance, psychological flexibility and quality of life of adolescents recovered from cancer.
Design
The clinical trial has a control group and an intervention group, double-blind, randomized block allocation, phase 3 on 42 patients.
Settings and conduct
The community consists of all recovered teenagers from Sartalan who have previously referred to Tehran Cancer Institute. The patients are selected as available, and then the statistician divides the patients into two groups without the knowledge of the patients and the therapist (double-blind), using the block random assignment method. Group therapy will be weekly for three sessions. Finally, according to the wishes of the patients in the control group, they can receive the mentioned treatment after follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 13-18 years
Completion of cancer treatment
Not having psychiatric medicine for reducing anxiety or depression
Not having psychotherapy now or last 3 months
No diagnosis of conduct disorders, confrontational disobedience, ADHD, and psychotic and bipolar spectrum disorders
Exclusion criteria: Dissatisfaction of the adolescent or family with the continuation of treatment
Cancer recurrence
Intervention groups
Intervention: online group therapy based on acceptance and commitment during three 90-minute sessions (one session per week)
Control: They will not receive treatment. If desired, after the follow-up treatment of the intervention group, it will be implemented on them as well.
Main outcome variables
quality of life; acceptability of intervention; acceptance; psychological flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210727052000N3
Registration date:2023-09-25, 1402/07/03
Registration timing:registered_while_recruiting
Last update:2023-09-25, 1402/07/03
Update count:0
Registration date
2023-09-25, 1402/07/03
Registrant information
Name
Fatemeh Hassani alimolk
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3566 1160
Email address
fatima.hassani75@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-21, 1402/05/30
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of applicability and feasibility and the effectiveness of acceptance and commitment therapy on quality of life and psychological flexibility of adolescent survivors with cancer experience
Public title
Acceptance and Commitment Therapy on adolescents with cancer experience
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 13-18 years
Completion of cancer treatment
Not having psychiatric medicine for reducing anxiety or depression
Not having psychotherapy now or last 3 months
No diagnosis of conduct disorders, confrontational disobedience, ADHD, and psychotic and bipolar spectrum disorders
Exclusion criteria:
Dissatisfaction of the adolescent or family with the continuation of treatment
Cancer recurrence
Age
From 13 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be available, but random allocation will be done by the professor of biostatistics without the knowledge of the patients and the therapist using the block method with the size of blocks of 3 and using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the initial sampling, patients and therapists are unaware that the patients will be in the control or intervention group. The statistical consultant professor performs block randomization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Cancer Institute of Tehran university of the medical sciences
Street address
Iran cancer institute/ East door of Imam Khomeini Hospital (RA)/ End of Keshavarz Blvd/ Tehran/ Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.223
Health conditions studied
1
Description of health condition studied
Adolescents survivors of cancer
ICD-10 code
COO-D48
ICD-10 code description
adolescent with cancer
Primary outcomes
1
Description
Quality of life
Timepoint
pre-test, post-test, 3 months follow-up
Method of measurement
The score of a person from the Adolescent Quality of Life Questionnaire (13-18 years old).
2
Description
Experimental avoidance
Timepoint
pre-test, post-test, follow-up
Method of measurement
Person's score from the Acceptance Avoidance subscale of the Acceptance and Action Questionnaire (AAQ-II).
3
Description
Psychological flexibility
Timepoint
pre-test, post-test, follow-up
Method of measurement
Person's score from the Acceptance and Practice Questionnaire (AAQ-II).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, survival adolescents from cancer receive 3 sessions that each session lasts 90-minute based on acceptance and commitment therapy that is compatible to their illness's conditions. Acceptance and commitment therapy is a type of contextual and experimental behavioral therapy and based on mindfulness that was developed by Dr. Steven Hayes in 1982, mentioned therapy is one of the third wave of psychological therapies. It consists of six basic processes: acceptance, cognitive defusion, being in the present moment, self as context, values and commitment. In fact, acceptance and commitment therapy means: accepting what is out of your control and committing to something that you can change and improves your living conditions.
Category
Other
2
Description
Control group: They donot recieve a psychotherapy. After the 3-months follow-up, they can recieve it if they want.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital of Tehran
Full name of responsible person
Fatemeh Hassani Alimolk
Street address
Anistitue cancer of Emam khomeini of Tehran, street of Dr. Gharib
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 1444
Email
fatima.hassani75@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zhaleh Karimimoghaddam
Street address
Zanjan University of Medical Sciences, Mhadavi street
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 0201
Email
zhkarimi@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be presented in the form of tables and graphs in the article. If requested by the judges or the editor, it will be made available to them after de-identification.
When the data will become available and for how long
The access period starts 6 months after the publication of the article
To whom data/document is available
Only researchers
Under which criteria data/document could be used
In order to use the results, methodology and tools used by researchers, they can send a request.
From where data/document is obtainable
To the responsible author or Fatima Hassani Ali Malek by email: fatima.hassani75@yahoo.com
What processes are involved for a request to access data/document
After receiving the email, the responsible author will be talked to, and if the request is correct, the requested information will be provided to the requester as soon as possible.