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The effectiveness of mindfulness-based cognitive therapy on post-traumatic growth, self-management and functional disability among patients with breast cancer.

Protocol summary

Summary
The aim of the study is the effectiveness of mindfulness-based cognitive therapy on post-traumatic growth, autonomy and functional disability in patients with breast cancer. Study design: Randomized, two experimental and control groups, single-center. The study population included 30 patients with breast cancer were selected, 15 were randomly assigned to an experimental group that received mindfulness-based cognitive therapy and 15 others are randomly placed in the control group. Inclusion criteria: age between 20 and 45 years, with the diagnosis of breast cancer by cancer specialists, lack of psychiatric disorders such as psychotic disorders and personality disorders, higher education cycle. Exclusion criteria: age younger than 20 and older than 45 years, multiple detection of breast cancer by cancer specialists, medical diagnosis at the same time, having psychotic disorders. Intervention and main outcome measures: Patients were randomly assigned to two experimental and control groups are substituted. During each session, mindfulness-based cognitive therapy is performed for 60 minutes. At its first meeting the required measures are taken to determine the base lines. Mindfulness-based cognitive therapy will be one session per week. The treatment protocol operations are provided. In the third session, fifth and once at the end of treatment and within one month and after a period of two months after the end of treatment, re-measurements are made. In order to comply with ethical principles, first obtaining the patient's informed consent.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080825732N7
Registration date: 2016-09-15, 1395/06/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-15, 1395/06/25
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University, Faculty of Psychology and Educational Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based cognitive therapy on post-traumatic growth, self-management and functional disability among patients with breast cancer.
Public title
The effectiveness of mindfulness-based cognitive therapy on post-traumatic growth, self-management and functional disability among patients with breast cancer.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having age between 20 and 45 years; with the diagnosis of breast cancer by cancer specialist; not having psychiatric disorders such as psychotic disorders and personality disorders; having a higher education cycle. Exclusion criteria: Having a lower age than 20 or older than 45 years; multiple detection of breast cancer by cancer specialists; medical Sickness diagnosis at the same time; having psychotic disorders.
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: 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
Ethics Committee, Semnan University
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
98/94/1285

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified

Primary outcomes

1

Description
Mindfulness-based cognitive therapy
Timepoint
Each week a session
Method of measurement
The proposed protocols - a standard questionnaire

2

Description
Illness severity
Timepoint
During treatment
Method of measurement
Control of confounding variables

Secondary outcomes

1

Description
Self-management evaluation
Timepoint
Before running the norms of the target population
Method of measurement
Activation patient questionnaire

2

Description
Evaluation of functional disability in patients with chronic pain
Timepoint
The questionnaire implemented before the target population of the norm.
Method of measurement
The World Health Organization Disability Assessment Questionnaire

Intervention groups

1

Description
In the control group, no intervention, was performed to compare the two study groups are just.
Category
Behavior

2

Description
The experimental group during each session mindfulness-based cognitive therapy is performed for 60 minutes. At its first meeting the required measures are taken to determine the base lines. Mindfulness-based cognitive therapy will be one session per week. The treatment protocol operations are provided. In the third session, fifth and once at the end of treatment and within one month and after a period of two months after the end of treatment, re-measurements are made.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Haft-e-Tir Hospital
Full name of responsible person
Dr Ehsagh Rahimian
Street address
Shahid Rajaei Street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Eshagh Rahimian
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University
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
Semnan University
Full name of responsible person
Dr Eshagh Rahimian
Position
Health Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
Hassan.norouzi@semnan.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Dr Eshagh Rahimian
Position
PhD in health Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
Hassan.norouzi@semnan.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Dr Eshagh Rahimian
Position
PhD in health Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
Hassan.norouzi@semnan.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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