Effectiveness of internet-based Acceptance And Commitment Therapy on Acceptance of Illness, Emotional Regulation and Reduction of Symptom Interference with Function in Patients with Breast Cancer
Determining the Effectiveness of internet-based Acceptance And Commitment Therapy on Acceptance of Illness, Emotional Regulation and Reduction of Symptom Interference with Function in Patients with Breast Cancer
Design
Randomized clinical trial, control group and random assignment by a person who is not aware of the research and treatment process, on 36 patients with breast cancer
Settings and conduct
At first, the eligible patients referred to Isfahan Macsa Center will be provided with informed consent and checklists and related questionnaires (basic evaluation), then patients are randomly assigned to one of the two control or experimental groups and The experimental group will receive acceptance and commitment therapy in the form of group video call during 10 sessions of 45 minutes, the control group will receive the education and support program in the form of group video call. Finally, after the sessions, using the tool The desired post-test and follow-up are performed 12 weeks later in both groups. The lead researcher and outcome assessors are unaware of the allocation of study groups.
Google Meet space will be used to form group meetings and WhatsApp will be used to follow and coordinate meetings and evaluations.
Participants/Inclusion and exclusion criteria
Inclusion:first and second stages of breast cancer،Age group under 55،At least 2 months and at most 6 months have passed from their active treatment
Exclusion:Unwillingness to continue the treatment process،The occurrence of major and severe physical problems ،Failure to complete the questionnaires
Intervention groups
The experimental group includes patients with breast cancer who receive Acceptance and commitment therapy.
The control group includes patients with breast cancer who receive Education and Support programs.
Main outcome variables
Emotional Regulation، Acceptance of Illness and Symptom Interference with Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211107052984N1
Registration date:2022-02-02, 1400/11/13
Registration timing:registered_while_recruiting
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Sara Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 9313
Email address
bagherian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of internet-based Acceptance And Commitment Therapy on Acceptance of Illness, Emotional Regulation and Reduction of Symptom Interference with Function in Patients with Breast Cancer
Public title
Effect of internet-based Act in breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the first and second stages of breast cancer
Age group under 55 years
At least 2 months and at most 6 months have passed from their active treatment
Lack of major psychiatric disorders such as schizophrenia and bipolar
Lack of other severe and chronic physical illnesses
Not receiving hospital care at the time of registration
Lack of severe inability to perform activities
Having motivation and desire to participate in psychotherapy sessions
Internet access
Exclusion criteria:
Unwillingness to continue the treatment process
Absence for more than 2 consecutive sessions and 3 sessions in general
The occurrence of major and severe physical problems
Hospitalization
Failure to complete the questionnaires
Age
To 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size consists of 36 women. There are currently three models of random allocation, and since this study is in two groups, the first generation prototyping model is used, each sample is placed in a treatment group and is done through the site https : // www. .randomize.net / which means that the assignment of samples to each of the two groups does not occur in the order of A and B, respectively, in the order in which the software output is placed.
Groups A and B enter the treatment groups section through the blocks on the site, The samples are then entered in the number of people in the treatment blocks, where the software randomly assigns each of the samples to one of the two groups A and B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine-Isfahan University of Medical Sciences
Street address
Department of Health Psychologyّ،Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-06, 1400/07/14
Ethics committee reference number
IR.MUI.MED.REC.1400.550
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Emotional Regulation
Timepoint
Before the intervention (Pre-test),After the intervention (Post-test),12 weeks after the intervention
Method of measurement
Difficulties in Emotion Regulation Scale
2
Description
Acceptance of Illness
Timepoint
Before the intervention (Pre-test) ,After the intervention (Post-test),12 weeks after the intervention
Method of measurement
acceptance of illness scale questionnaire
3
Description
Symptom Interference with Function
Timepoint
Before the intervention (Pre-test),After the intervention (Post-test),12 weeks after the intervention
Method of measurement
The MD Anderson Symptom Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Internet-based Acceptance And Commitment Therapy *Session 1: Housekeeping, Group Culture, Conceptualization, Creative Hopelessness *Session 2: Control as the Problem/Willingness *Session 3: Willingness/Defusion *Session 4: Deliteralization /Defusion *Session 5: Contacting the Present *Session 6: Self-as-Context *Session 7: Values Clarification *Session 8: Committed Action *Session 9: Pulling it all together *Session 10:Conclusion and Ask about useful aspects of therapy ,Ask about areas that client will struggle with going forward and Say goodbye.
Category
Treatment - Other
2
Description
Control group(Education/Support): *Session 1: *Session 2: Overview of quality of life issues *Session 3:Discussion of physical quality of life *Session 4:Discussion of social quality of life and referral to resources *Session 5:Discussion of emotional quality of life and referral to resources *Session 6:Discussion of Cognitive and spiritual quality of life quality of life and referral to resources *Session 7: Discussion of quality of financial life and referral to resources *Session 8 :Tips for evaluating health information in books,magazines, and websites *Session 9 : Review of prior sessions and referral to websites with cancer-related information *Session 10 :Conclusion and Ask about useful aspects of therapy ,Ask about areas that client will struggle with going forward and Say goodbye.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ala Cancer Prevention and Control Center (Macsa))
Full name of responsible person
Mohamadreza Sharbafchi
Street address
No. 29, Amin al-Dawle Dead End, 35th Alley, after Shiri Bridge,Motahhari St.
City
Esfahan
Province
Isfehan
Postal code
8184933473
Phone
+98 31 3233 3029
Fax
+98 31 3233 1051
Email
info@macsa.ir
Web page address
https://macsa.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh haghjooye javanmard
Street address
Isfahan University of Medical Sciences,,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Email
saramirzaeiii997@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sara mirzaei
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Health Psychologyّ،Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Email
saramirzaeiii997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara mirzaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Health Psychologyّ،Isfahan University of Medical Sciences
City
Student
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Email
saramirzaeiii997@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara mirzaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Health Psychologyّ،Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Email
saramirzaeiii997@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
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 are potentially shareable after patients are unidentifiable.
When the data will become available and for how long
After completing the process and publishing the article.
To whom data/document is available
It will be accessible to researchers, students, medical staff and patients.
Under which criteria data/document could be used
If it is for the purpose of scientific advancement and therapeutic progress of patients as well as the expansion of the present research, sending the request is unrestricted.