Couple therapy adaptation on the life quality and mental health of patients with breast cancer and their spouses and comparing the results to those of control group : Effectiveness study
Objectives: Objectives: This study aims at investigating the effects of couple therapy adaptation on patients with breast cancer and their spouses and studying the efficacy of this adaptive treatment on the life quality and mental health of those spouses and comparing the results to those of control group.
Design: This study is a semi-experimental research based on pre-test and post-test with a control group. Research population consists of all patients with breast cancer, having come to Shahid Ghazi Hospital for Chemotherapy. From the above-mentioned population, 40 subjects have been selected through available non-random sampling
Execution: Subjects are divided into two experimental and control groups in a random manner. Then, subjects in the experimental group are being trained for “breast cancer adaptation” in 6 sessions. Subjects in control group will not receive any training.
Criteria for Entrance to and Exit from the Study: Diagnosis of breast cancer in the subjects and their high education are of criteria for entering into the study. Lack of knowledge regarding the disease and lack of inclination of patients’ spouses for attending at intervention sessions are of criteria for exiting from the study.
Interventions: Subjects in both experimental and control groups will be initially tested using measuring tools for mental health and life quality. Then, subjects in the experimental group are being trained for “breast cancer adaptation” and will be post-tested for the extent of change in life quality (elementary consequent variable) and mental health (secondary consequent variable) and compared to those in control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013113015590N1
Registration date:2014-01-27, 1392/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Mansoor Beyrami
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 313 4470
Email address
m.bayrami@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Expected recruitment start date
2013-12-23, 1392/10/02
Expected recruitment end date
2014-02-21, 1392/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Couple therapy adaptation on the life quality and mental health of patients with breast cancer and their spouses and comparing the results to those of control group : Effectiveness study
Public title
Couple therapy adaptation on patients with breast cancer and their spouses=Effectiveness study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of breast cancer, Self awareness from cancer, high education in patients, education in patients in their partner,Chemotherapy
Exclusion criteria: Have other disease (for example: other kind of cancer), Lack of knowledge regarding the disease, lack of inclination of patients’ spouses for attending at intervention sessions
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
4tth office,First Floor, Ghazi Hospital, Tabriz University, Golghasht Street
City
Tabriz
Postal code
2356
Approval date
2013-11-22, 1392/09/01
Ethics committee reference number
92159
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Quality of life
Timepoint
Before treatment and 1 week after treatment
Method of measurement
Quality of life Scale
2
Description
General health
Timepoint
before treatment and 1 week after treatment
Method of measurement
GHQ Scale
Secondary outcomes
empty
Intervention groups
1
Description
Experiment group will intervened with adaptation program in 6 sessions. The component of intervention is: Knowing about cancer and breast cancer, Stress control, Relaxation, Positive relationship with partner, Identifying partner sense and emotions.
Category
Behavior
2
Description
Control group do not receipt any treatment program.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Pari Ghaem
Street address
2th office, First Floor, Ghazi Hospital, Tabriz University, Golghasht Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hematology and Oncology Research , Tabriz University of Medical Scienc
Full name of responsible person
Jamal Eyvazi
Street address
3rth office,First Floor, Ghazi Hospital, Tabriz University of Medical Sciences, Golghasht Street
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, Hematology and Oncology Research , Tabriz University of Medical Scienc
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
Tabriz University
Full name of responsible person
Shirin Zeinali
Position
PhD student in Tabriz University
Other areas of specialty/work
Street address
Child Psychology Office, Fifth Floor, Milad building, Corner of MlliBank,17 Shahrivar Street
City
Tabriz
Postal code
Phone
+98 41 1557 5849
Fax
Email
shirinzeinali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Shirin Zeinali
Position
PhD student in Tabriz university
Other areas of specialty/work
Street address
Child Psychology Office, Fifth Floor, Milad building, Corner of MlliBank,17 Shahrivar Street
City
Tabriz
Postal code
Phone
+98 41 1557 5849
Fax
Email
shirinzeinali@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)