The aim of this study is to investigate the effect of combined teaching method on self efficacy of breast cancer patients and their family caregivers strain. This study is a randomized controlled trial. Participants will be selected from patients referring to Ghazi Hospital of Tabriz University of medical sciences. The main inclusion criteria is breast cancer diagnosis and the main exclusion criteria is participating in similar teaching programs. After giving conscious consent, patients will be allocated to either control or intervention groups. Intervention group will receive at least 2 face to face sessions including learning about the disease, pain control methods, nutritional points, managing side effects related to chemotherapy according to patient or caregivers need. Brochures about teaching materials will be given to patients too. Teaching will be conducted by role playing whenever needed. For 4 weeks patients will be followed by telephone in order to answer to patients and families possible questions and guide them if needed. Control group will receive routine care and after finishing the study written material will be given to them. Finally the self efficacy of patients and their family care givers strain will be determined and compared before and after the study in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206196810N2
Registration date:2012-07-03, 1391/04/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-03, 1391/04/13
Registrant information
Name
Alireza Mohajjel Aghdam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mohajjela@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimethod education on self efficacy of patients with breast cancer and their family care givers strain
Public title
The effect of education on self efficacy of patients with breast cancer and their family care givers strain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Breast cancer diagnosis; Undergoing chemotherapy; Existence of a family member; Ability to attend teaching Sessions; Tendency to attend in study; Knowing at least reading and writing; First sessions of treatment; Equal treatment for all participants. Exclusion criteria: Attending in the same educational or research programs; Having somebody with the same disease in family and friends; Inability to attending educational Sessions; Interaction of participants; Being nurse or doctor; History of mental disorder or bad events about the caregiver.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Postal code
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
9142
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Family caregiver strain
ICD-10 code
F99
ICD-10 code description
Unspecified mental disorder
Primary outcomes
1
Description
Self efficacy of breast cancer patients
Timepoint
before the intervention and four weeks after the intervention
Method of measurement
Based on a scale to measure self-efficacy of cancer patients
2
Description
Family caregivers Strain of breast cancer patients
Timepoint
before the intervention and four weeks after the intervention
Method of measurement
Based on a scale to measure caregivers strain index
Secondary outcomes
empty
Intervention groups
1
Description
Patients and family in intervention group will receive 2 sessions of teaching with combining of several teaching methods like verbal teaching, giving written materials and role playing; then, to follow up the patients and their family, phone calls will be made to answer possible questions and giving directions. Content of teaching includes the concept of disease, chemotherapy side effects and their management.
Category
Other
2
Description
Control group receives routine care and after the study brochures of information will be given to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology Oncology research centre (Ghazi hospital)
Full name of responsible person
Zahra Kochaki nejad Eram Sadati
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Sakineh Mohamad Alizadeh
Street address
Faculty of Nursing & Midwifery of Tabriz , Shariety South St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, 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
Tabriz university of medical sciences
Full name of responsible person
Zahra Kochaki nejad Eram Sadati
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Tabriz, Shariety South St.
City
Tabriz
Postal code
Phone
+98 41 1479 7713
Fax
Email
sarasadat70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Alireza Mohajjel Aghdam
Position
Faculty member, Master of nursing, medical surgical nursing
Other areas of specialty/work
Street address
Medical-Surgical nursing group, Faculty of Nursing & Midwifery of Tabriz, Shariety South St.
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
mohajjela@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical sciences
Full name of responsible person
Zahra Kochaki najad Eram Sadati
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Tabriz , Shariety South St.
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
sarasadat70@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)