Mind -fullness therapy (based on cognitive therapy) on irrational beliefs and social appraisal of cancer patients with appearance change: Effectiveness study
Objectives: Objectives: This study aims at the effects of mind -fullness therapy (based on cognitive therapy) on cancer patients with appearance change (such as changing in face, cutting body, sever alopecia) and studying the efficacy of this treatment on the irrational beliefs and social appraisal 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 cancer patients with appearance change. From the above-mentioned population, 40 subjects have been selected through available non-random sampling. Execution: Subjects are divided into two experimental and control groups in a random manner. Then, subjects in the experimental group are being trained for “mind -fullness therapy” in 8 sessions. Subjects in control group will not receive any training. Criteria for Entrance to and Exit from the Study: Diagnosis of breast cancer in the subjects, visible physical appearance change during cancer treatment (such as changing in face, cutting body, sever alopecia) and their high education are of criteria for entering into the study.
accompanied diseases (such as diabetes), 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 irrational beliefs and social appraisal. Then, subjects in the experimental group are being trained for “mind -fullness therapy” and will be post-tested for the extent of change in irrational beliefs and social appraisal (elementary consequent variable) and compared to those in control group
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040815590N2
Registration date:2014-04-21, 1393/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-21, 1393/02/01
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
Hematology and Oncology Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mind -fullness therapy (based on cognitive therapy) on irrational beliefs and social appraisal of cancer patients with appearance change: Effectiveness study
Public title
Mind-fullness therapy on cancer patients with appearance change: Effectiveness study
Purpose
Health service research
Inclusion/Exclusion criteria
Diagnosis of breast cancer in the subjects, visible physical appearance change during cancer treatment (such as changing in face, cutting body, sever alopecia) and their high education are of the criteria for entering into the study.
Exclusion criteria: accompanied diseases (such as diabetes); lack of knowledge regarding the disease and lack of inclination of patients for attending at intervention sessions.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Tabriz University of Medical Sciences
Street address
2th office, First Floor, Ghazi Hospital, Tabriz University, Golghasht Street
City
Tabriz
Postal code
Approval date
2014-04-19, 1393/01/30
Ethics committee reference number
9310
Health conditions studied
1
Description of health condition studied
Amputation leg
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Alopecia
ICD-10 code
L64.0
ICD-10 code description
Drug-induced androgenic alopecia
3
Description of health condition studied
Amputation of hand
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Social appraisal
Timepoint
before and after treatment
Method of measurement
Self talk Scale
2
Description
Irrational beliefs
Timepoint
before and after treatment
Method of measurement
Irrational Beliefs Scale
Secondary outcomes
empty
Intervention groups
1
Description
Experiment group will intervened with mind-fullness program in 8 sessions. The component of intervention is: Knowing about cancer , Relaxation, coping with irrational beliefs and replacing Positive thoughts.
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
Street address
1rth office, First Floor, Ghazi Hospital, Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hematology and Oncology Research , Tabriz University of Medical Scienc
Full name of responsible person
Jamal Eyvazi
Street address
3rth office, First Floor, Ghazi Hospital, Tabriz University of Medical Sciences, Golghasht Street
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, Hematology and Oncology Research , Tabriz University of Medical Scienc
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
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Zeinali
Position
PhD Student
Other areas of specialty/work
Street address
3rd Floor, Faculty of Psychology, Tabriz University, Emam Street
City
Tabriz
Postal code
51868434
Phone
+98 41 1281 4815
Fax
Email
Shirinzeinali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Zeinali
Position
PhD Student
Other areas of specialty/work
Street address
3rd Floor, Faculty of Psychology, Tabriz University, Emam Street
City
Tabriz
Postal code
51868434
Phone
+98 41 1281 4815
Fax
Email
Shirinzeinali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Zeinali
Position
PhD student
Other areas of specialty/work
Street address
3rd Floor, Faculty of Psychology, Tabriz University, Emam Street
City
Tabriz
Postal code
51868434
Phone
+98 41 1281 4815
Fax
Email
Shirinzeinali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)