The purpose of the current trial is to study whether a support intervention based on widely used spiritual intervention could improve the quality of life of breast cancer patients in comparison to the control group or not. The target population is newly diagnosed breast cancer patients under radiation therapy who consents to participate in this study. The participants will be randomly assigned into control group receiving standard management and treatment and also routine education program or intervention group receiving both routine management/education and also an additional 6 sessions (6 weeks) educational program based on spiritual therapy intervention. The spiritual therapy sessions include: introduction, relaxation and meditation, control, identity, relationships with self, others and God, prayer therapy. The quality of life will be assessed by The specific European Organisation for Research and Treatment of Cancer quality of life group for breast cancer (EORTC BR-23 and QLQC30) and the spirituality will be assessed by FACIT-SP12.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904024242N1
Registration date:2011-05-31, 1390/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-31, 1390/03/10
Registrant information
Name
Najmeh Jafari
Name of organization / entity
Isfahan University of Medical Sciences (IUMS)
Country
Iran (Islamic Republic of)
Phone
+98 31 1771 1112
Email address
n_jafari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-09-20, 1389/06/29
Expected recruitment end date
2010-10-30, 1389/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of The effect of Spiritual Therapy for Improving the Quality of life in Women with Breast Cancer
Public title
Assessment of The effect of Spiritual Therapy for Improving the Quality of life in Women with Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Newly diagnosed breast cancer patients, Active participation in educational programs Exclusion criteria: Patients who do not consent to participate, Metastatic Breast cancer patients, Concomitant chronic disease, Major depression disorder
Age
From 18 years old to 70 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
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
The ethics committee of Isfahan University of Medical Sciences research administration
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
Approval date
2010-12-25, 1389/10/04
Ethics committee reference number
389319
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 intervention and after that( six weeks after initiation on intervention)
Method of measurement
EORTCQLQC30 and BR23 questionnaires
Secondary outcomes
1
Description
spirituality
Timepoint
before intervention and after that( six weeks after initiation on intervention)
Method of measurement
FACIT-SP12 questionnaire
Intervention groups
1
Description
Intervention group: both routine management/education and also an additional 6 sessions (6 weeks) educational program based on spiritual therapy intervention. The spiritual therapy sessions include: introduction, relaxation and meditation, control, identity, relationships with self, others and God, prayer therapy
Category
Lifestyle
2
Description
Control group: patients in control group will receive standard management and treatment and also routine education program in 6 weeks period.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Cancer Research Center/St. S. Al-shohada hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Adibi
Street address
Hezarjeryb Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Najmeh Jafari
Position
MD/resident of community medicine
Other areas of specialty/work
Street address
131,Mirzataher Street
City
Isfahan
Postal code
Phone
+98 913 126 8172
Fax
Email
n_jafari@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmadreza Zamani
Position
MD/community medicine specialist
Other areas of specialty/work
Street address
Community Medicine Department
City
Isfahan
Postal code
Phone
+98 31 1792 2452
Fax
Email
zamani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Najmeh Jafari
Position
MD/Resident of Community Medicine
Other areas of specialty/work
Street address
131-Mirzataher Street
City
Isfahan
Postal code
Phone
+98 31 1771 1112
Fax
Email
n_jafari@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)