The purpose of the study: determine the effect of education and telephone counseling on the self-efficacy of women with breast cancer undergoing radiotherapy. Design of the study: clinical trial. The study Population: All women with breast cancer referring to the radiotherapy of cancer institute of Imam Khomeini. Inclusion criteria: Aged of 18 to 64 years, the definitive diagnosis of breast cancer, the first ever radiation therapy experience, at the same time you do not receive chemotherapy, Having a landline and cell phone, Proficiency in Persian. Exclusion criteria: Unwillingness to continue cooperation, Disconnect the phone for 2 weeks in the first month of intervention and for 3 weeks in the second and third months of intervention, Hospitalization during the period of the research. Sample size: 32 patients in the experimental group and 32 patients in the control group. Interventions studied and intervention time: The intervention method in the intervention group is through training via SMS and consultation through a telephone call for 3 months, A training short message sent for patients daily, Telephone counseling will be done by making 2 calls per week in the first month and one call per week in the second and third months. Chronic Disease Self-Efficacy Scale Before, one month and three months after the intervention will be completed for both groups. Primary outcome or study outcome : If the impact of education and telephone counseling on the self-efficacy of women with breast cancer undergoing radiotherapy is identified, telephone counseling centers in radiation therapy centers can be established.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082835955N1
Registration date:2017-10-03, 1396/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Asma Satiyarvand
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3226 6174
Email address
a-satiyarvand@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Education And Telephone Counseling On The Self- Efficacy Of Women With Breast Cancer Undergoing Radiotherapy
Public title
Effect Of Education And Telephone Counseling On The Self-Efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: aged of 18 to 64 years , definitive diagnosis of breast cancer, first radiation therapy experience, lack of simultaneous chemotherapy, fixed and mobile phone numbers, fluency in Farsi, lack of familial communication with other participants in the study, lack of speech and hearing problems , Lack of dementia and cognitive impairment. Exclusion criteria: reluctance to continue cooperation, disconnect for 2 weeks in the first month of intervention and for 3 weeks in the second and third month of intervention, hospitalization during the study period, metastasis And died
Age
From 18 years old to 64 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the random allocation of binary blocks is used
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Myrkhani Street, Towhid Square, Tehran
City
Tehran
Postal code
1419733171
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1655
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
Self-efficacy score
Timepoint
Before, one month and three months after educaion and telephone counseling
Method of measurement
- Chronic Disease Self-Efficacy Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: The intervention method in the intervention group is through training via SMS service and consultation by phone call for 3 months. Daily an educational short message sent to patients about radiotherapy, skin changes, laryngeal disorders, nausea and vomiting, diarrhea, fatigue, psychosocial issues, immune deficiency, fertility and lactation, lymphedema, and cardiovascular and pulmonary complications. Telephone counseling is also done by making 2 calls per week in the first month and 1 call per week in the second and third months. The content of the first 12 conversations that took place during 2 months included radiation therapy, skin changes, laryngeal disorders , nausea and vomiting, diarrhea, fatigue, psychosocial issues, immune deficiency , fertility and lactation, lymphatic edema, and cardiovascular and pulmonary complications of radiation therapy. And the last 4 conversations that take place in the third month to follow the patients' status and respond to patient questions.
Category
Behavior
2
Description
The control group receives routine training at Imam Khomeini Cancer Center, which includes a one-on-one training session with the presentation of the pamphlet, but will not receive any training from the researcher.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Imam Khomeini Cancer Institute
Full name of responsible person
Asma Satiyarvand
Street address
Tehran Faculty of Nursing and Midwifery, Mirkhani Street, Towhid Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Asma Satiyarvand
Street address
Tehran Faculty of Nursing and Midwifery, Mirkhani Street, Towhid Square, Tehran
City
Tehran
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,Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Asma Satiyarvand
Position
MSc student of Medical-Surgical Nursing
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
a-satiyarvand@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asama Satiyarvand
Position
MSc student of Medical-Surgical Nursing
Other areas of specialty/work
Street address
Tehran Faculty of Nursing and Midwifery, Mirkhani Street, Towhid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
a-satiyarvand@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asma Satiyarvand
Position
MSc student of Medical-Surgical Nursing
Other areas of specialty/work
Street address
Tehran Faculty of Nursing and Midwifery, Mirkhani Street, Towhid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
a-satiyarvand@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)