The effectiveness of the intervention of using a mobile educational application on the burden of complications caused by chemotherapy and the care burden of elderly caregivers with gastrointestinal cancer compared to the conventional method.
Determining the effect of mobile-based educational program on the complications of chemotherapy in the elderly undergoing chemotherapy and the care burden of caregivers
Design
The clinical trial has a control and intervention group with parallel groups and is not blinded and randomized and has a sample size of 90 patients and spss software was used for randomization.
Settings and conduct
This research was conducted in Omid and Imam Reza Hospital and Reza Medical Center of Mashhad, and the control group and intervention group are from one center and the other two centers. Then they will be given the demographic characteristics and questionnaires of Zarit's care burden and Anderson's burden of complications, and the application will be installed on the patient's caregivers' mobile phones, they will receive the necessary training based on the experienced complication, and the control group will receive only conventional training. And after the completion of the research, this software will be provided to the control group, and the second round of filling the questionnaires will be after the completion of the fourth session of chemotherapy, and the third round will be one month after the completion of the fourth session of chemotherapy.
Participants/Inclusion and exclusion criteria
Diagnosis of chemotherapy;
non-metastatic cancer;
Gastrointestinal cancer;
Age over 60 years;
Starting the second course of chemotherapy;
Exclusion criteria:
Disaffiliation;
The death of an elderly person.
Intervention groups
In the intervention group, in addition to face-to-face training, an educational application is installed on the mobile phones of their caregivers. In the control group, the same educational content will be given through face-to-face teaching method.
Main outcome variables
The amount of care burden of the patient and the amount of complications of chemotherapy for the elderly
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201205049613N1
Registration date:2022-10-02, 1401/07/10
Registration timing:retrospective
Last update:2022-10-02, 1401/07/10
Update count:0
Registration date
2022-10-02, 1401/07/10
Registrant information
Name
Malihe Khalilnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3821 1545
Email address
khalilniam2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
2021-05-05, 1400/02/15
Actual recruitment end date
2021-08-06, 1400/05/15
Trial completion date
2021-08-06, 1400/05/15
Scientific title
The effectiveness of the intervention of using a mobile educational application on the burden of complications caused by chemotherapy and the care burden of elderly caregivers with gastrointestinal cancer compared to the conventional method.
Public title
Investigating the effectiveness of using a mobile phone educational application on the elderly with gastrointestinal cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chemotherapy for the patient
Individual or combination therapy
No history of surgery
Non-metastatic cancer
No vision or hearing problems
Not receiving previous training
Gastrointestinal cancer (stomach, esophagus, colon, which does not have an ostomy)
Age over 60 years
Start of the second course of chemotherapy
Having physical ability and consciousness
Exclusion criteria:
Not having an Android mobile phone available
Lack of literacy
Unwillingness to participate in research
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In a simple way, people are divided into two groups by SPSS software. This sequence is kept in a sealed envelope. After confirming the entry criteria for each of the research units, the researcher will open the door of the envelope and will determine change his group based on this sequence. This procedure will continue until the completion of the people of both research groups.
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
School of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University Street, Khorasan Razavi
City
مشهد
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.090
Health conditions studied
1
Description of health condition studied
Gastrointestinal (stomach) cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
2
Description of health condition studied
Gastrointestinal cancer (esophagus)
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of oesophagus
3
Description of health condition studied
Gastrointestinal cancer (colon)
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Care burden of elderly caregivers undergoing chemotherapy
Timepoint
In three cases, the first time before the start of the second round of chemotherapy, the second time after the end of the fourth course of chemotherapy and the third time one month after the fourth session of chemotherapy, the first and second rounds of primary outcomes are measured and the third round of outcomes Secondary is measured
Method of measurement
Using specific questionnaires
2
Description
The burden of complications in the elderly undergoing chemotherapy
Timepoint
In three cases, the first time before the start of the second round of chemotherapy, the second time after the end of the fourth course of chemotherapy and the third time one month after the fourth session of chemotherapy, the first and second rounds of primary outcomes are measured and the third round of outcomes Secondary is measured
Method of measurement
Using specific questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to face-to-face training, a mobile phone-based training program will be installed and trained on caregivers' mobile phones.
Category
Other
2
Description
Face-to-face training by nurses and educational pamphlets by the researcher
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital (AS) and Omid Hospital and Reza Chemotherapy Center (Qasimabad)
Full name of responsible person
Research assistant of the organization
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University Street, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
NAMResearch@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research assistant of the organization
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University Street, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
NAMResearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Valizadeh Zare
Position
Faculty of Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University Street, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ValizadehN@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Valizadeh Zare
Position
Faculty of Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University Street, Khorasan Razavi
City
MASHHAD
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ValizadehN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Valizadeh Zare
Position
Faculty of Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University Street, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ValizadehN@mums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Can be shared after identifying people
When the data will become available and for how long
Access since 1401
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
najme valizade zare-nvalizade zare@mums.ac.ir
What processes are involved for a request to access data/document
The applicant will send an email to the person in charge of the project and it will be sent after reviewing the information.