Protocol summary

Summary
Objective: Determining the effect of education on applying coping strategies and quality of life among women with breast cancer. Inclusion criteria: Age less than 60 years old, Literate, Is living in Shiraz, Patients’ agreement to participate in the study, Having been in the stages 1, 2 and 3 of the illness, Surgery and adjuvant therapy is completed, Has not participated in an educational program applying coping strategies previously. Exclusion criteria: Unwillingness of the patient to continue cooperating in the study, Metastasis to other organs or recurrence, Lymph edema is caused by the inability of the patient, Stressful events in a period close to the time of completing the questionnaire, Incidence to during the study of mental disease - psychological, Chronic disease or other malignancies during the study. Method: Randomized clinical trial with intervention and control. Groups population: Patients with breast cancer referred to Mottahari clinic shiraz university of medical sciences. Sample: 105 Patients (50 of Patients in intervention group and 55 Patients in control group). Intervention: Educational programs of quality of life and coping strategieswere held as four sessions as group discussion and lecture for experiment group and questionnaire coping strategies and quality of life (before, one month and two months after intervention) were used at three different periods. Study outcome: Primary outcome was quality of life and coping strategies of the Patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091610844N1
Registration date: 2014-05-28, 1393/03/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-28, 1393/03/07
Registrant information
Name
Somayeh Ramezanli
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
ramezanli@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy Shiraz University of Medical Sciences
Expected recruitment start date
2012-08-25, 1391/06/04
Expected recruitment end date
2013-03-10, 1391/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of education on application of coping strategies and quality of life in women with breast cancer
Public title
The impact of education on application of coping strategies and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age less than 60 years old; Literate; Is living in Shiraz; Patients’ agreement to participate in the study; Having been in the stages 1, 2 and 3 of the illness; Surgery and adjuvant therapy is completed; Has not participated in an educational program applying coping strategies previously. Exclusion criteria: Unwillingness of the patient to continue cooperating in the study; Metastasis to other organs or recurrence; Lymph edema is caused by the inability of the patient; Stressful events in a period close to the time of completing the questionnaire; Incidence to during the study of mental disease - psychological; Chronic disease or other malignancies during the study (according to specialist physician).
Age
To 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 105
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

1

Registry name
00
Secondary trial Id
00
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Seventh floor, Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Postal code
71345-1978
Approval date
2012-08-12, 1391/05/22
Ethics committee reference number
CT-91-6270

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
Quality Of Life
Timepoint
Before, one month and two months after intervention
Method of measurement
Questionnaire EORTC QLQ-C30

Secondary outcomes

1

Description
Coping Strategies
Timepoint
Before, one month and two months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Education program on quality of life and coping strategies was conducted in 5 groups weekly for one month as group discussion and lecture for patients with breast cancer then one month or 2 after educational sessions in order to determine the effectiveness of this intervention, questionnaires were completed.
Category
Lifestyle

2

Description
Routine Care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Clinic Shiraz
Full name of responsible person
Fatemeh Hashemi
Street address
Namazi sq.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Seventh floor, Shiraz University of Medical Sciences and Health Services, Zand blvd
City
Shiraz
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 of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
MS in nursing
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraze
Postal code
Phone
+98 71 1646 6560
Fax
Email
hashemif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
MS in nursing
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Phone
00
Fax
Email
hashemif@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Ramezanli
Position
MS in nursing
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Phone
00
Fax
Email
ramezanli1362@gmail.com
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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