Protocol summary

Study aim
determining the effect of Mindfulness-Based Stress Reduction (MBSR) group consultation with or with out partner on psychological reaction and some inflamatory tests of women with breast cancer refered to physicians offices and medical settings of Kerman University of Medical Sciences, 2018
Design
Clinical clinical trial with a control group with parallel, randomized groups
Settings and conduct
Eight weekly sessions Group counseling of stress-based mindfulness in two intervention groups with and without spouse's, and comparison of stress, anxiety and depression before and after intervention using a questionnaire, as well as the level of cortisol and CRP before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Women with married breast cancer who have been between 3 months and 5 years of age since diagnosis began. 2- Not using any psychological treatment before and during the period during which the subjects undergo intervention. 3. Non-addiction to any drug 4. Non-acute psychiatric disorders (psychosis, severe mood disorder, etc.) based on self-report 5. Not having mental disorders 6. Non-use of anti-anxiety and anti-depressant drugs 7. Have at least one course of chemotherapy or surgery 8- The age of 18-70 years 9. Breast cancer without metastasis 10-No use of corticosteroids, psychedelic and hormonal drugs Exit criteria: 1- Absence (the patient or his wife) in more than 3 sessions of the MBSR sessions 2. Unwillingness to attend the study 3. Physical inability due to illness and treatment 4- Start taking corticosteroids, fluorescent and hormonal drugs 5- In the event of a major crisis during or about three months before intervention, such as the death of loved ones 6. Co-infection with autoimmune diseases 7. History of participation in mindfulness groups 8. Endocrine diseases like Cushing
Intervention groups
In the intervention group, eight weekly sessions of mindfulnes are counseling for a Interventions group, with the difference that in a group women with breast cancer are involved in the presence of a spouse, and in another group, women with breast cancer are absent from their husbands.
Main outcome variables
Stress, anxiety, depression, cortisol and CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180113038333N1
Registration date: 2018-02-15, 1396/11/26
Registration timing: registered_while_recruiting

Last update: 2018-02-15, 1396/11/26
Update count: 0
Registration date
2018-02-15, 1396/11/26
Registrant information
Name
Motahare Mirmahmoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3285 0744
Email address
m.mirmahmodi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mindfulness-Based Stress Reduction (MBSR) group consultation with or with out partner on psychological reaction and some inflammatory tests of women with breast cancer referred to physicians offices and medical settings of Kerman University of Medical Sciences, 2018
Public title
The effect of Mindfulness-Based Stress Reduction (MBSR) group consultation with or with out partner on psychological reaction and some inflammatory tests of women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with breast cancer without metastases Age between 18 and 70 years Married
Exclusion criteria:
acute psychiatric disorders (psychosis, severe mood disorder, etc.) based on self-report take corticosteroid, psychedelic and hormonal drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignments will be used by blocking. In this way, in each block, two of the intervention group in the presence of the spouse, two of the intervention group will enter the intervention group without the presence of the spouse and two participant of control group
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
Deputy of Research and Technology of Kerman University of Medical Sciences
Street address
tahmasebabad
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.KMU.REC.1396.440

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50.11
ICD-10 code description
Malignant neoplasm of central portion of breast, female

Primary outcomes

1

Description
depression
Timepoint
Before and after intervention
Method of measurement
Beck Depression Inventory

2

Description
anxiety
Timepoint
Before and after intervention
Method of measurement
Beck anxiety inventory

3

Description
stress
Timepoint
Before and after intervention
Method of measurement
Perceived Stress Scale

4

Description
cortizol
Timepoint
Before and after intervention
Method of measurement
blood test

5

Description
C-reactive protein (CRP)
Timepoint
Before and after intervention
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Eight weekly sessions A group mindfulness- based stress redaction for women with cancer at the presence of spouse
Category
Lifestyle

2

Description
Intervention group: Eight weekly sessions A group mindfulness- based stress redaction for women with cancer without spouse presence
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Sedighe Iranmanesh
Street address
Haftbagh
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.mirmahmodi@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abas Pardakhti
Street address
Haftbagh
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mirmahmoodi95@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Sedighe Iranmanesh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haftbagh of Kerman University of Medical Sciences. Razi Nursing and Midwifery Faculty
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mirmahmoodi95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sedighe Iranmanesh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haftbagh of Kerman University of Medical Sciences. Razi Nursing and Midwifery Faculty
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mirmahmoodi95@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Motahare Mirmahmoodi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
11, bostanmahdi ave.,havanirooz blv
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3285 0744
Fax
Email
mirmahmoodi95@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 main consequence of the data is publishable
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
individuals in academic institutions
Under which criteria data/document could be used
The personal data of the participants is not available
From where data/document is obtainable
Motahare Mirmahmoodi . mirmahmoodi95@gmail.com
What processes are involved for a request to access data/document
Six months after the publication of the article 2019
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