This study examined the effect of group education to partners on the social adaptation of women with breast cancer undergoing chemotherapy. In this study, 56 women with breast cancer undergoing chemotherapy were included. This study was designed as pretest-posttest with a control group. Patients eligible to participate in the study were randomly assigned into two intervention (28 = n) and control (28 = n) groups. For spouses of patients in the intervention group, six 2-hour sessions were held. Spouses of patients in the control group didn't receive any intervention. Social Adjustment Scale (SAS-m) was completed by patients before and after intervention. Social adjustment in both groups are compared before and after the intervention and with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111420778N7
Registration date:2016-06-16, 1395/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-16, 1395/03/27
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
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2016-01-15, 1394/10/25
Expected recruitment end date
2016-04-13, 1395/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Group education to the partners on social adaptation of women with breast cancer undergoing chemotherapy
Public title
The effect of group education to the partners on social adaptation
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: aged 20-60 years, understanding Persian language, afflicting with breast cancer, not affected by another cancer, not experienced stressful events in previous 6 months. Exclusion criteria included any stressful event for the patient or the patient's first-degree family and being absent in more than two training sessions.
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:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Postal code
571478334
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.UMSU.REC.1394.299
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
c50.9
ICD-10 code description
z60.0
Primary outcomes
1
Description
Social adjustment
Timepoint
Before and after the intervention.
Method of measurement
Social Adjustment Scale (SAS-M)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
In the intervention group educational sessions for partners of women with breast cancer are held as 2-hour sessions once a week for six weeks (six 2-hour sessions)
Category
N/A
2
Description
The control group received no intervention whatsoever.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Support Community of Saba in Bukan
Full name of responsible person
Hesam Soltany
Street address
Farhang Town, Uromia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Doctor Fatemeh Moghadam Tabrizi
Street address
Urmia University of Medical Sciences, next to the emergency center, Resalat bolvar
City
Urmia
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, 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
F. Moghaddam Tabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Midwifery and Nursing, Nazloo
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4963
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
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Midwifery and Nursing, Nazloo
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4963
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
F Moghadam Tabrizi doctor
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Midwifery and Nursing, Nazloo
City
urmia
Postal code
5714783734
Phone
+98 44 3275 4963
Fax
Email
fmtabrizi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)