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The effect of nursing counseling through video call on the quality of life of patients with breast cancer

Protocol summary

Study aim
Determining the effect of nursing consultation through video call on the quality of life of patients with breast cancer
Design
A controlled clinical trial, with a control group, without blinding, non-random, the sample size included 80 patients who were selected if they met the entry criteria.
Settings and conduct
At the Hassan Mojtabi Radiotherapy Oncology Center, after selecting the samples according to the entry criteria and obtaining informed consent, the study begins. Before the intervention, the demographic information and quality of life QLQ-C30 questionnaire is filled by the samples. Patients receive nursing counseling for 4 weeks, 2 sessions for 10-15 minutes each week. A week after the end of the sessions, the QLQ-C30 quality of life questionnaire is completed again by the patients. Finally, the data is analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
Entry criteria: having breast cancer, age range of 30 to 65 years, having mental stability and informed consent, not having participated in educational and counseling programs in the last month, and having a mobile phone and internet access. Non-entry criteria: Lack of consent to participate in research, lack of mobile phone and internet access.
Intervention groups
The research is conducted in 4 weeks, and the test group receives 2 sessions per week and a total of 8 nursing counseling sessions for 10-15 minutes by the researchers. The control group includes breast cancer patients who do not receive nursing advice from the researchers, and will not participate in other educational programs during our research.
Main outcome variables
People's scores in QLQ-C30 quality of life questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170607034381N9
Registration date: 2024-04-12, 1403/01/24
Registration timing: prospective

Last update: 2024-04-12, 1403/01/24
Update count: 0
Registration date
2024-04-12, 1403/01/24
Registrant information
Name
Ferdos Pelarak
Name of organization / entity
Dezful Azad University
Country
Iran (Islamic Republic of)
Phone
+98 916 941 7091
Email address
pelarak.f@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing counseling through video call on the quality of life of patients with breast cancer
Public title
The effect of nursing counseling through video call on the quality of life of patients with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having breast cancer Patients aged 30 to 65 years Having mental stability and conscious satisfaction Not participating in educational and counseling programs in the last month
Exclusion criteria:
Lack of mobile phone and internet access Lack of consent to participate in the research
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not 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
Research ethics committee of Islamic Azad University, Dezful branch
Street address
University Blvd, Azadegan
City
Dezful
Province
Khouzestan
Postal code
6461645169
Approval date
2023-04-24, 1402/02/04
Ethics committee reference number
IR.IAU.D.REC.1402.034

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
People's scores in QLQ-C30 quality of life questionnaire
Timepoint
Checking the quality of life of the participants before the start of the intervention and one week after the end of the intervention
Method of measurement
QLQ-C30 quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After completing the quality of life questionnaire and demographic information by the test group, the counseling sessions will begin. In this way, during 4 weeks (2 sessions per week), nursing counseling for 10-15 minutes will be given by the researchers to the test group. Based on the quality of life questionnaire, the test group receives counseling related to various items of this questionnaire (including physical, emotional, fatigue, nausea, pain, sleep disorder, loss of appetite, constipation and diarrhea, etc.). One week after the end of the intervention, the quality of life questionnaire will be completed by the test group.
Category
Other

2

Description
Control group: It includes patients with breast cancer who do not receive nursing advice from the researchers and will not participate in other educational programs during our research. Questionnaires are also completed by this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Radiotherapy and oncology center of Imam Hassan Mojtabi, Dezful city
Full name of responsible person
Mohammadreza Ismail Chegeni
Street address
Baath Boulevard, Baharestan Alley, Dezful
City
Dezful
Province
Khouzestan
Postal code
6461945386
Phone
+98 61 4243 0000
Email
imandustmobina@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vice Chancellor for Research, Islamic Azad University of Dezful
Street address
Azadegan Street, University Blvd., Islamic Azad University
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0606
Email
info@iaud.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina Imandust
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azadegan Street, University Boulevard, Islamic Azad University
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0606
Email
imandustmobina@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina Imandust
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azadegan Street, University Boulevard, Islamic Azad University
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0606
Email
imandustmobina@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina Imandust
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azadegan Street, University Boulevard, Islamic Azad University
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0606
Email
imandustmobina@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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