Group Acceptance and Commitment Therapy (ACT) on pain related anxiety and Cognitive Emotion Regulation in Breast cancer patients and comparing with control group
Objectives: This study is the effects of group acceptance and Commitment therapy on pain related anxiety and cognitive emotion regulation in breast cancer patients and comparing the results to those of control group. Design: This study is a semi-experimental research based on pre-test and post-test with a control group. Research population consists of all breast cancer patients. From the above-mentioned population, 30 subjects have been selected through available non-random sampling. Setting and conduct: Subjects are divided into two experimental and control groups in a random manner. Then, subjects in the experimental group are being trained for logo therapy in 8 sessions. Subjects in control group will not receive any training. Major Inclusion and Exclusion criteria: Diagnosis of breast cancer in the subjects, Self awareness from cancer, high education are of criteria for entering into the study. Accompanied diseases (such as other cancer), lack of knowledge regarding the disease and lack of inclination of patients for attending at intervention sessions are of criteria for exiting from the study. Interventions: Subjects in both experimental and control groups will be initially tested using measuring tools for pain related anxiety and cognitive emotion regulation .Then, subjects in the experimental group are being trained for “acceptance and Commitment therapy” and will be post-tested for the extent of change pain related anxiety and cognitive emotion regulation and compared to those in control group. Main outcome measures: coping strategies, hope and adjustment are elementary consequent variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100615590N5
Registration date:2017-10-16, 1396/07/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
Mansoor Beyrami
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 313 4470
Email address
m.bayrami@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Group Acceptance and Commitment Therapy (ACT) on pain related anxiety and Cognitive Emotion Regulation in Breast cancer patients and comparing with control group
Public title
Acceptance and commitment therapy on cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of breast cancer; Self awareness from cancer; high education in patients Exclusion criteria: Have other disease (for example: other kind of cancer); Lack of knowledge regarding the disease; lack of inclination of patients for attending at intervention sessions
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee for Ethics in biomedical research of Tabriz University of Medical Science
Street address
4tth office, First Floor, Ghazi Hospital, Tabriz University of Medical Science, Golghasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
TBZMED.REC.1396.625
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Cognitive emotion regulation
Timepoint
Before treatment and 1 week after
Method of measurement
Cognitive emotion regulation Questionnaire
2
Description
Pain related anxiety
Timepoint
Before treatment and 1 week after
Method of measurement
Pain related anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Experiment group will intervened with acceptance and commitment therapy in 8 sessions. The component of intervention is: Knowing about the breast cancer, coping with stress, Relaxation, having relationship with body, accept pain and suffer.
Category
Behavior
2
Description
Control group do not receipt any treatment program.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Pari Ghaem
Street address
2th office, First Floor, Ghazi Hospital, Tabriz University of Medical Science, Golghasht Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Zohreh Sanat
Street address
3rth office, First Floor, Ghazi Hospital, Tabriz University of Medical Sciences, Golghasht Street, Tabriz
City
Tabriz
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,Tabriz 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
Islamic Azad University Of Ahahr
Full name of responsible person
Shirin Zeinali
Position
PhD
Other areas of specialty/work
Street address
Child Psychology Office, Fourth Floor, Milad building, Corner of Mlli Bank, 17 Shahrivar Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3557 5849
Fax
Email
shirinzeinali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Ahar
Full name of responsible person
Roghaye Keyani
Position
PhD
Other areas of specialty/work
Street address
Faculty of Psychology, Islamic Azad University of Ahar University, Ahar
City
Ahar
Postal code
Phone
+98 414324432
Fax
Email
Ps.mkiyani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Ahar
Full name of responsible person
Shirin Zeinali
Position
PhD
Other areas of specialty/work
Street address
Faculty of Psychology, Tabriz University, Emam Street, Tabriz Tabriz
City
Tabriz
Postal code
Phone
+98 41 3557 5849
Fax
Email
shirinzeinali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)