Protocol summary

Summary
Objectives: Determine the effect of Peer-based support on health-promoting behaviors in breast cancer survivors in academi hospitals and research centers in Urmia. Setting and conduct:This study will be performed on 140 breast cancer survivors in academi hospitals and research centers in Urmia in 2015-16. Data collection tool will be individual information form, Health-promoting life style profile inventory. Inclusion criteria: age between 20 and 60; definitive diagnosis of breast cancer etc. Exclusion criteria : absence of more than two sessions of meetings ,have any stressful event for the patient or the immediate family of the patient. Intervention: Those women will be randomly entered into the study groups (70 Person in each group). The intervention group in six peer-led group discussions, participated once a week, and interventional control group will not receive. Main outcome measures:Improve health-promoting behaviors.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080720778N17
Registration date: 2016-09-06, 1395/06/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-06, 1395/06/16
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-11, 1395/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Peer-based support on health-promoting behaviors in breast cancer survivors in academi hospitals and research centers in Urmia in 2015-16
Public title
The Effect of Peer-based support on health-promoting behaviors in breast cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 60; definitive diagnosis of breast cancer; not having other cancer; patients Mastectomy undergoing chemotherapy or radiotherapy; grade 1, 2 and a 3 breast cancer; not having severe depression Exclusion criteria: absence of more than two sessions of meeting ; have any stressful event for the patient or the immediate family of the patient
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
urmia university of medical sciences
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Postal code
5714783734
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.UMSU.rec.1394238

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50.8
ICD-10 code description
Overlapping lesion of breast

Primary outcomes

1

Description
Health-promoting behaviors
Timepoint
Before and 2 month after Intervention
Method of measurement
Health-promoting lifestyle profile

Secondary outcomes

empty

Intervention groups

1

Description
Interventional control group did not receive.
Category
Treatment - Drugs

2

Description
Peer-led group discussions
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Medical Research Center
Full name of responsible person
Javad Khashabi
Street address
Farhangian,
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Lila Najafi
Street address
Azadeghan Street
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Position
PHD/Assistant Professor
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Nazloo, Uromia
City
Urmia
Postal code
Phone
+44 32754964
Fax
Email
fmtabrizi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Position
phd
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Nazloo, Uromia
City
Urmia
Postal code
Phone
+98 44 3385 0004
Fax
Email
fmtabrizi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Position
PHD/Assistant Professor
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Nazloo, Urmia
City
Urmia
Postal code
Phone
+98 44 3385 0004
Fax
Email
fmtabrizi@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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