Comparison the impact of informing about the management of chemotherapy side effects with the help of an artificial intelligence tool with phone support in breast cancer patients
1- Comparison of the changes of cancer patients self-efficacy about chemotherapy side effects in 3 study groups
2-Comparison of the side effects severity of patients during the chemotherapy in 3 study groups
3- Comparison of the level of anxiety of patients in 3 study groups
Design
The trial will be randomized and blinded on 60 breast cancer patients with 3 parallel groups. Allocation of people to each group will be done randomly using a table of random numbers.
Settings and conduct
After optimizing the online smart nurse system, the number of breast cancer patients referring to Seyed al-Shohda Hospital in Isfahan, Iran, aged 18 to 75 years, who have received chemotherapy, are randomly selected. Then, patients will be randomly allocated to three groups; smart nurse, telephone support, and control. Additionally, each group will not know the type of intervention of the other groups. Finally, after 6 months, using the checklist will be made by the researcher, the three groups are compared in terms of awareness and self-efficacy in managing side effects, severity of side effects and intensity of anxiety. Data analysis of 3 groups is done with the help of SPSS software.
Participants/Inclusion and exclusion criteria
1-Breast cancer patients who have received chemotherapy
2-Breast cancer patients who have a high school education or higher literacy level
3-Breast cancer patients who want to enter the study
4-Breast cancer patients who have the ability to work with computers and the Internet
Intervention groups
1- The group using the smart nurse
2-The group using telephone support
3- The control group
Main outcome variables
Self-efficacy of patients in managing the side effects of chemotherapy drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240206060919N1
Registration date:2024-04-18, 1403/01/30
Registration timing:prospective
Last update:2024-04-18, 1403/01/30
Update count:0
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
shiva shirani-bidabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 3705
Email address
shivashirani@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the impact of informing about the management of chemotherapy side effects with the help of an artificial intelligence tool with phone support in breast cancer patients
Public title
Investigating the effect of informing about the management of the chemotherapy side effects with the help of artificial intelligence tool
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
breast cancer patients who have received chemotherapy
breast cancer patients who have a high school education or higher literacy level
breast cancer patients who want to enter the study
breast cancer patients who have the ability to work with computer and the Internet
Exclusion criteria:
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
People are randomly assigned to 3 groups using the random number table method, one group to use the smart nurse, the second group to use telephone support, and the third group as a control group that includes receiving the usual previous care and referral. They will visit the doctor. 60 numbers will be prepared according to the random number table according to the number of samples. After eligible patients visit the hospital and in the order of their visit, each patient will be assigned a number, according to the random placement of the numbers, one patient will be in the smart nurse group, the next patient will be in the telephone support group, and the next patient will be in the control group.
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 Committees of Research Ethics Committee of the "Alzahra Research Centers"
Street address
University Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hezar Jrib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-02-03, 1402/11/14
Ethics committee reference number
IR.ARI.MUI.REC.1402.284
Health conditions studied
1
Description of health condition studied
side effects of chemotherapy drugs in patients with breast cancer
ICD-10 code
Y43.3
ICD-10 code description
Cancer chemotherapy drug regimen, adverse effect in therapeutic use
Primary outcomes
1
Description
The percentage of self-efficacy of breast cancer patients in managing the side effects of chemotherapy drugs
Timepoint
6 months after the beginning of the intervention
Method of measurement
symptom-management’s self-efficacy scale-breast cancer (SMSES-BC) questionnaire
Secondary outcomes
1
Description
The level of anxiety about the side effects of chemotherapy drugs
Timepoint
6 months after the intervention
Method of measurement
A global measure of perceived stress by Cohen
Intervention groups
1
Description
First intervention group: Smart nurse users group for getting information about chemotherapy side effects management, The collected information about how to manage the side effects of chemotherapy drugs, collected from reliable sources such as cancer research UK, will be used to train and optimize an intelligent online system to answer questions with patients about side effects management. respond to chemotherapy drugs.
Category
Other
2
Description
The second intervention group: the group using the telephone support, which will be answered by a nurse skilled in the field of chemotherapy with the help of a telephone conversation, answering to the patients' questions about how to manage the side effects of chemotherapy drugs.
Category
Other
3
Description
Control group: They do not receive intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al-shohada (Omid) Hospital
Full name of responsible person
Abdollah Asgari
Street address
Seyed al-shohada (Omid) Hospital, Farshadi Alley, Khayam St., Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3235 0210
Email
shivashirani@res.mui.ac.ir
Web page address
https://omid.mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research and Technology Vice-Chancellor of Isfahan University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jrib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Shiva Shirani bidabadi
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Cancer Prevention Research Center, Seyed al-shohada Educational and Therapeutic Center, Motahari St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3237 1103
Email
shivashirani@res.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Rahmanian
Position
Research Associate
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Cancer Prevention Research Center, Seyed al-shohada Educational and Therapeutic Center, Motahari St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3237 1103
Email
narges.rahmanian@res.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shiva Shirani bidabadi
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Cancer Prevention Research Center, Seyed al-shohada Educational and Therapeutic Center, Motahari St., Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3237 1103
Email
shivashirani@res.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We share the questionnaires completed by the patients without mentioning their names with a unique code for each person
When the data will become available and for how long
from 2026
To whom data/document is available
It will be available only to researchers working in scientific institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
The main researchers of the project: Shiva Shirani Bidabadi, Narges Rahmanian
shivashirani@res.mui.ac.ir
narges.rahmanian@res.mui.ac.ir
What processes are involved for a request to access data/document
Applicants can request documents or data files by sending an email to the main researchers of the project