Increasing the quality of life, self-efficacy and spiritual well-being of women with breast cancer
Design
Individuals are randomly assigned into two groups of control and experiment with a sample size of 70 people.
Settings and conduct
Spiritual care is performed in 6 sessions in selected centers of Qom with control and intervention group. After completing the intervention and follow-up two months, a similar intervention is performed in the control group
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Women with Iranian nationality aged 18-65
2. A definitive diagnosis of breast cancer (at each of stages 1 to 4) with pathological tests
3-Minimum 2 months of receiving diagnosis
4. Not having severe mental illness.
5. There is no other stressful event, such as divorce and death, of a close relative during the past year.
6. Aware of the time and place
7. Reading and writing literacy
8. Ability to speak Persian language.
9. Lack of disability and disability
10. Being Muslim.
Exclusion criteria:
1-Patient dissatisfaction to continue the study
2-foot patient.
3-Lack of more than two sessions of spiritual care sessions
Intervention groups
The intervention group is group of women with breast cancer who have inclusion criteria and are randomly assigned to a intervention group that holds spiritual care for 6 sessions per week for them. This intervention is in relation to God, others, himself and the world of nature.The focus of those topics is prayer, repentance and passing, tendencies, patience, trust and happiness if there is no spiritual care for the control group at this time.
Main outcome variables
Increasing the quality of life
Increased self-efficacy
Increase spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037279N2
Registration date:2018-05-17, 1397/02/27
Registration timing:registered_while_recruiting
Last update:2018-05-17, 1397/02/27
Update count:0
Registration date
2018-05-17, 1397/02/27
Registrant information
Name
farzaneh nasiri
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 453 6915
Email address
farzanehnasiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-13, 1397/01/24
Expected recruitment end date
2018-06-14, 1397/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effect Spiritual Care on Spiritual Health, Quality of Life and Self-efficacy in Women with Breast Cancer
Public title
The effect of spiritual care on spiritual health, quality of life and self-efficacy in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with Iranian nationality
A definitive diagnosis of breast cancer (at each stage 1 to 4) with pathological tests
Passed 2 months after receiving diagnosis
Not having severe mental illness, including psychotic or bipolar disorder
Failure to deal with another tense event, such as the divorce and death of a close relative during the past year
Aware of the time and place
Literacy reading and writing
Ability to speak Persian
Lack of disability and disability
Being Muslim
Exclusion criteria:
Dissatisfaction patients to continue the study
Patient death
Missing more than two sessions of spiritual care sessions
Age
From 18 years old to 64 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done individually and random numbers are used
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Has an intervention and control group that runs after intervention and two months follow up for the control group to observe ethical issues of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Valiasr St., Intersection of Prayer, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
644.1395.PHNM.SBMU.I
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life score in the short form of quality of life of the World Health Organization
Timepoint
Before intervention, immediately after the intervention and two months after the end of the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire Short Form
2
Description
Self-efficacy score of Sherer's general self-efficacy questionnaire
Timepoint
Before intervention, immediately after the intervention and two months after the end of the intervention
Method of measurement
Sherer General Self-efficacy Inventory
3
Description
Spiritual Health Score in Palutzin & Ellison Spiritual Health Questionnaire
Timepoint
Sherer General Self-efficacy Inventory
Method of measurement
Palutzin & Ellison Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention for the experimental group is 6 sessions per week. Intervention sessions are designed based on the review of existing texts and resources. Interventions are related to communication with God, others, themselves and the world of nature, whose focus is on prayer, repentance and passage, altruism, patience, trust.
Category
Other
2
Description
Control group: During the spiritual care intervention for the control group, there is no specific action, but after two months follow up to observe moral issues of spiritual care for them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadra center
Full name of responsible person
Zohreh Keshavarz
Street address
no.19 .Alley10، Street 19 D
City
Qom
Province
Ghoum
Postal code
1985717443
Phone
+98 25 3771 2825
Email
farzanehnasiri100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatyan
Street address
Valiasr St., intersection of prayer, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
farzanehnasiri100@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Keshavarz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr St., intersection of prayer, opposite Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
keshavarzzohre@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farzaneh nasiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 919 453 6915
Fax
Email
farzanehnasiri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farzaneh nasiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 919 453 6915
Fax
Email
farzanehnasiri@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is shareable because people are not identifiable
When the data will become available and for how long
Start the access period 2 months after printing the results
To whom data/document is available
The votes of researchers working in academia and academia will be available
Under which criteria data/document could be used
With the permission of the researcher
From where data/document is obtainable
farzanehnasiri100@gmail.com
What processes are involved for a request to access data/document