Protocol summary

Summary
Objectives : The aim of this study is to determine the effect of cognitive therapy based on mind-awareness on the quality of life of women with breast cancer. Design and method: In this study, 30 breast cancer patients were randomly divided into control and intervention groups based on entry and exit criteria and after explaining the study and obtaining written consent. Inclusion Criteria: Women with breast cancer in the age-group 18 and older; reading and writing literacy; not being affected by another cancer; not being treated with psychiatric medications. Inclusion criteria: Not attending sessions for more than one session; Using neurological drugs; not being at the relapse of the disease. After obtaining written and verbal consent, they are randomly divided into two intervention and control groups by lot. Both patients are matched in double blocks (one patient in the intervention group and another one in the control group). The questionnaires are available to both groups at the beginning of the study. The intervention-based cognitive therapy based on the mindfulness of consciousness, according to the protocol, is held 8 sessions of 40 minutes and twice a week (only for the intervention group) in the Cancer division The hospital (classroom). After accomplishing the intervention, immediately the post-test of the groups is performed. After one month, the questionnaires will be returned to both groups and the quality of life will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072235227N1
Registration date: 2017-09-19, 1396/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Kolsoum Abdollahi Far
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9770
Email address
k.abdollahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2017-06-25, 1396/04/04
Expected recruitment end date
2017-07-26, 1396/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cognitive Therapy Based on Knowledge on Quality of Life in Women with Breast Cancer.
Public title
The Effect of Mindfulness on the Quality of Life of Women with Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women with breast cancer in the age- group 18 and older who have been diagnosed the disease in their medical records; patients should be able to write, read and answer the questions; they should not have another cancer; they should have completed stages of surgical and chemotherapy treatment; They should not have drug abuse; they should be able to attend group therapy sessions; they should not be treated with psychiatric medications while conducting research. Exclusion criteria: Being absent from the intervention sessions for more than one time; Using nerve drugs to reduce symptoms of anxiety and depression; Not being at the onset of relapse of the disease.
Age
From 18 years old to 54 years old
Gender
Female
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)
Single 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 Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
19839-63113
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SBMU.PHNM.1395.695

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
D24
ICD-10 code description
Benign neoplasm of breast

Primary outcomes

1

Description
Quality of Public Life
Timepoint
Before and Immediately After the Intervention and One Month After The Intervention
Method of measurement
Questionnaire

2

Description
Quality of Private Life
Timepoint
Before and Immediately After the Intervention and One Month After The Intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive awareness-based cognitive therapy for one month (8 sessions)
Category
Behavior

2

Description
Control group: The control group does not receive intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
kolsoum Abdollahi Far
Street address
End of Keshavarz Blv, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Private
Full name of responsible person
Kolsoum Abdollahi Far
Street address
End of Keshavarz Blv, Tehran, Iran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Camelia Rohani
Position
Ph.D. Nursing
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
19839- 63113
Phone
+98 21 2243 9770
Fax
-
Email
camellia.rohani@sbmu.ac.ir
Web page address
sbnmf@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayyebeh Jamshidi
Position
Masters
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
19839- 63113
Phone
+98 21 2243 9770
Fax
-
Email
tjamshidi62@gmail.com
Web page address
sbnmf@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
kolsoum Abdollahi Far
Position
Master's Student Psychiatric Nursing
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
19839- 63113
Phone
+98 21 2243 9770
Fax
-
Email
k.abdollahi@sbmu.ac.ir; abdollahi_1393@yahoo.com
Web page address
sbnmf@sbmu.ac.ir

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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