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Determining the effect of continues care model on health promotion behaviors of breast cancer survivors referring to the Educational, Research, and Therapeutic Centers of Urmia in 2017

Protocol summary

Study aim
Determining the effect of continues care model on health promotion behaviors of breast cancer survivors referring to the Educational, Research, and Therapeutic Centers of Urmia in 2017
Design
Considering the criteria for entering the study, 60 patients and one of the active members of the family to take care of the patient, participate in the study, using the availability method and filling the written consent form. And by using an envelope containing odd or even numbers, the participants will be chosen randomly to be in the control group (N= 30) or in the intervention group (N= 30).
Settings and conduct
Demographic questionnaire, family support questionnaire, and health promotion lifestyle questionnaire are first filled in both groups, and then follow-up care model is provided for intervention group, whereas the control group receives routine care. Classes will be held at one of the private clinics in groups of 5 families in 6 sessions within a week interval.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes: Age range from 20 to 60, familiarity with Persian and Turkish languages, diagnosis of breast cancer, not having other types of cancer, having had mastectomy, completing breast cancer treatment (chemotherapy, radiotherapy, hormone therapy), degrees of 1, 2, 3a of breast cancer based on the pathology sheet, not having another stressful experience in the last 6 months, gaining score below 23 in public health screening (GHQ28 questionnaire), and not attending another training sessions.
Intervention groups
Classes will be held at one of the private clinics in groups of 5 families in 6 sessions, within a week interval. In each session, topics from the items of the life style health questionnaire will be discussed.
Main outcome variables
Health promotion behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150125020778N20
Registration date: 2018-05-20, 1397/02/30
Registration timing: retrospective

Last update: 2018-05-20, 1397/02/30
Update count: 0
Registration date
2018-05-20, 1397/02/30
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
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of continues care model on health promotion behaviors of breast cancer survivors referring to the Educational, Research, and Therapeutic Centers of Urmia in 2017
Public title
The effect of continues care model on health promotion behaviors in breast cancer survivors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria includes: Age range from 20 to 60, familiarity with Persian and Turkish languages, diagnosis of breast cancer, not having other types of cancer, having had mastectomy, completing breast cancer treatment (chemotherapy, radiotherapy, hormone therapy), degrees of 1, 2, 3a of breast cancer based on the pathology sheet, not having another stressful experience in the last 6 months, gaining score below 23 in public health screening (GHQ28 questionnaire), and not attending another training sessions.
Exclusion criteria:
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the criteria for entering the study, and having filled the consent paper, 60 patients and one of the active members of the family to take care of the patient, take part in the study, utilizing the availability method. And by using an envelope containing odd or even numbers, the participants will be chosen randomly to be in the control group (N= 30) or in the intervention group (N=30).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Based on odd or even being randomly 30 patients for control group ,and 30 patients for intervention group will select.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University Of Medical Sciences
Street address
Resalat Blv, next to the emergency center، Urmia University Of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
Ir.umsu.rec1396.278

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
Health promotion behaviors
Timepoint
Before intervention and 6 weeks after the first session
Method of measurement
Health-Promoting Lifestyle Profile questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: counseling program , discussion and following up , consisting of patients and one of the active elements of the family which consist of 6 groups and in each group there are 5 families.it will be held weekly in 6 sessions that will last one or one and a half hour and in each sessions titles will be discussed , from the items of the life style health questionnaire (mental health , physical activity , interpersonal communication , nutrition , stress management health resposibility0in which the patient and his family mention their ongoing challenges to the debate and in order to solve the problems , appropriate solutions depending on the topic will be taken. Using brochures and pamphlets by researchers for more impact will be provided. Notepads will also be provided to the patients so that they can write their daily behaviors at intervals between sessions and report the process of doing behaviors in each sessions so the researchers can evaluate the impact of skills acquired in a person and solve the problems and barriers with the help of the patient and his family and promote the positive hints as much as possible.
Category
Lifestyle

2

Description
Control group: The control group will not receive the any intervention. But due to ethical norms that they were in the control group, after the intervention, one or two sessions will do for them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Dr. Fatemeh Mogaddam Tabrizi
Street address
Ershad street, Ayatollah Modarres blvd, Imam Khomeini hospital
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Fax
+98 44 3346 9935
Email
fmtabrizi@gmail.com
Web page address
http://www.umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj mohebbi
Street address
Resalat Blv, next to the emergency center، Urmia University Of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Phone
+98 44 3223 4897
Email
Irajmohebbi@umsu.ac.ir
Web page address
httpp://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery department, Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44332754963
Email
fmtabrizi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Moghaddam Tabrizi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery department, Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44332754963
Email
fmtabrizi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Moghaddam Tabrizi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery department, Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44332754963
Email
fmtabrizi@gmail.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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
I have not decided yet - its publication plan is still unclear
When the data will become available and for how long
I have not decided yet - its publication plan is still unclear
To whom data/document is available
I have not decided yet - its publication plan is still unclear
Under which criteria data/document could be used
I have not decided yet - its publication plan is still unclear
From where data/document is obtainable
I have not decided yet - its publication plan is still unclear
What processes are involved for a request to access data/document
I have not decided yet - its publication plan is still unclear
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