The effect of group counselling on health promoting lifestyle and quality of life in women who have undergone mastectomy: a randomized controlled clinical trial
Objectives: To determine the effect of group counselling on health promoting lifestyle and quality of life in women who have undergone mastectomy.
Design: Randomized controlled trial.
Conduct: This study will be conducted on 76 women under the age of 60 years old who have undergone mastectomy during the last five years in state and private hospitals of Tabriz. The researcher will refer to hospital and will select eligible women through convenience sampling method and the questionnaires of HPLP-2 will be completed and the women who obtain score lower than 3 will be included in study and written consent will be obtained and also Quality of Life Questionnaire-Cancer 30 will be completed. Participants will be randomly assigned into two groups of counseling and control through block randomization.
Participants: 76 women who have undergone mastectomy during the last five years.
Intervention: For the intervention group (n= 38), six 60 to 90 minute group counseling once a week will be provided. The control group (n= 38) will receive routine cares.
The main outcome variables include health promoting lifestyle and quality of life that will be assessed before intervention, four and eight weeks after the intervention through HPLP-2 and Quality of Life Questionnaire-Cancer 30.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062510324N40
Registration date:2017-08-16, 1396/05/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-23, 1396/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counselling on health promoting lifestyle and quality of life in women who have undergone mastectomy: a randomized controlled clinical trial
Public title
The effect of group counselling on health promoting lifestyle and quality of life in women who have undergone mastectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age less than 60 years old; Passing of at least 1 year and a maximum of 5 years from mastectomy; Obtaining HPLP-2 score less than 3.
Exclusion criteria: History of severe mental illness (such as depression, bipolar, schizophrenia) according to woman’s expression; Taking psychiatric drugs or psychotropic substances; Having other cancers; Recent occurrence of tragic events; Previous participation in counseling classes for prompting lifestyle.
Age
To 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Ethics committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Postal code
Approval date
2017-08-07, 1396/05/16
Ethics committee reference number
IR.TBZMED.REC.1396.376
Health conditions studied
1
Description of health condition studied
Lifestyle
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Health promoting lifestyle
Timepoint
Before intervention, four and eight weeks after the intervention
Method of measurement
HPLP-2 questionnaire
2
Description
Quality of life
Timepoint
Before intervention, four and eight weeks after the intervention
Method of measurement
Quality of Life Questionnaire-Cancer 30
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, six 60 to 90 minute group counseling once a week will be provided.
Category
Lifestyle
2
Description
The control group will receive routine cares.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz state and private hospitals
Full name of responsible person
Manirah Hamed Biyabani
Street address
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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 Tabriz 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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Monireh Hamed Biyabani
Position
MSc student of conseling in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Iran
Phone
+98 41 3479 6770
Fax
Email
m_hamed64@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Iran
Phone
+98 41 3479 6770
Fax
Email
mirghafourvandm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Manirah Hamed Biyabani
Position
MSc student of conseling in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Iran
Phone
+98 41 3479 6770
Fax
Email
m_hamed64@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)