Studying Effect of Cognitive-Behavioural Stress Management(CBSM) program on occupational performance and adjustment women with breast cancer, attending to MRI center and Hamadan Theraputic Facilities, 2015
Breast cancer is the most common cancer among women. Short recovery times and the best possible functioning of patients after breast cancer operations should be the key interests of rehabilitation. Most studies in the field of breast cancer rehabilitation still have a major concern with impairments, although a shift of interest is gradually taking place towards broader conceptualization of the aspects of health. The International Classification of Functioning, Disability and Health (ICF), published by WHO . Many studies have reported flaws in upper limb function in these patients, however a little is known about activity limitations and participation restrictions. Diagnosis and treatment of primary breast cancer in women present a series of challenges often resulting in stress, emotional distress, difficulty in adjustment and decreased social interactions.Studies have shown effectiveness cognitive behavioral therapy in hard and chronic medical conditions due to the long-term effects of this treatment on depression, anxiety and quality of life, especially in patients with breast cancer respectively. According to the findings, the aim of this study evaluate the effect of cognitive-behavioral stress management on occupational performance and adjustment in women with breast cancer referred to medical centers in Hamedan
General information
Acronym
Cognitive-Behavioural Stress Management(CBSM)
IRCT registration information
IRCT registration number:IRCT2016051224468N1
Registration date:2016-05-29, 1395/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Farkhondeh Jamshidi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
f.jamshidi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-05-06, 1395/02/17
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying Effect of Cognitive-Behavioural Stress Management(CBSM) program on occupational performance and adjustment women with breast cancer, attending to MRI center and Hamadan Theraputic Facilities, 2015
Public title
Studying Effect of Cognitive-Behavioural Stress Management(CBSM) program on occupational performance and adjustment women with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age range between 20-60 years old; 2) Being married; 3) Women with breast cancer Grade 3 or lower after surgery (regardless of the type of surgery); 4) Level of Education: High School to the top; 5) Willing to participate in research and cooperate in all phases of evaluations.
Exclusion criteria: 1) History of chronic physical and mental illnesses such as psychotic disorders such as schizophrenia, severe depression and ...; 2) Participate in more than one educational session; 3) The occurrence of stressful events (death of someone close, divorce, etc.) while studying; 4) The existence of mental retardation; 5) Drug abuse.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Pajohesh Intersection, Shahid Fahmideh Blvd., Opposite the Mardom Park
City
Hamadan
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.UMSHA.REC.1395.32
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
Adjustment
Timepoint
Before and one week after intervention
Method of measurement
Bell adjustment questionnaire
2
Description
Occupational performance
Timepoint
Before and one week after intervention
Method of measurement
Canadian occupational performance questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: intervention does not take place.
Category
N/A
2
Description
The intervention group counseling, stress management, 4 sessions of 60 minutes each, for 4 weeks.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Imam Khomeini Clinic
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Pajohesh Intersection, Shahid Fahmideh Blvd., Opposite the Mardom Park
City
Hamadan
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 and Technology 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
Hamadan University of Medical Sciences
Full name of responsible person
Farkhondeh Jamshidi
Position
Faculty member
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Pajohesh Intersection, Shahid Fahmideh Blvd., Opposite the Mardom Park
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
farkhondeh.jamshidi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farkhondeh Jamshidi
Position
Master of sciences(MSc)
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Pajohesh Intersection, Shahid Fahmideh Blvd., Opposite the Mardom Park
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
farkhondeh.jamshidi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farkhondeh Jamshidi
Position
Faculty member
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Pajohesh Intersection, Shahid Fahmideh Blvd., Opposite the Mardom Park
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
farkhondeh.jamshidi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)