Determining the effect of Covid-19 self-care education through virtual social networks on quality of life and anxiety in cancer patients
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on 70 patients. The quadruple block method was used for randomization.
Settings and conduct
The research is carried out in Shafa specialized hospital in Ahvaz.
The first questionnaire is completed. Individuals are then randomly divided into two groups of intervention and control. Educational intervention is performed for the intervention group. The second round of the questionnaire is completed immediately after the intervention and the third round is completed one month after the end of the intervention.
Participants/Inclusion and exclusion criteria
All cancer patients
Intervention groups
In this study, the intervention group of Covid-19 self-care training through WhatsApp software in the form of educational text messages, related images and video training (related videos) daily (8 am to 8 pm) with 2 to 3 messages for two They receive the week. There is no intervention for the control group during this period.
Main outcome variables
quality of life and coronavirus disease are dependent variables.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211025052863N1
Registration date:2021-12-06, 1400/09/15
Registration timing:prospective
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Hanie Amirifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4263 5121
Email address
amirifar7575@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care education for Covid-19 through virtual networks on quality of life and anxiety of patients with cancer
Public title
Effect of self-care education on quality of life and anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
At least 6 months have passed since the diagnosis of cancer
Ability to read and write
Having a smart phone
Access and ability to use social media
Patient willingness to participate in the study
No known mental illness
No drug addiction
Lack of underlying disease that impairs quality of life
Exclusion criteria:
Unwillingness to continue participating in the study
Lack of access to participants during the study for any reason (including death)
History of Covid-19 disease and experience of grief and illness of family members in the last 6 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 70 patients with various types of cancer (diagnosed by a physician) were included in the study by available sampling method and by applying inclusion criteria. Then the samples were randomly divided into two groups of 35 with random allocation in the intervention (A) and control (B) groups. First, the four blocks were defined as follows: ABAB, BBAA, BABA, BAAB, AABB, ABBA, etc., and then these blocks were numbered and the blocks were determined using a table of random numbers, and the individuals were ranked A and B. They were divided into intervention and control groups. Patient A was in the intervention group of education through WhatsApp virtual social network and patient B was in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is done as a control case. Sample individuals are divided into case and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
No23 ,Hekmat ave.
City
andimeshk
Province
Khouzestan
Postal code
6481866455
Approval date
2021-05-09, 1400/02/19
Ethics committee reference number
IR.ARAKMU.REC.1400.022
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
quality of lie in cancer patients
Timepoint
Before the intervention, immediately after the end of the intervention, one month after the end of the intervention.
Method of measurement
QLQ-C30 Quality of Life Questionnaire
2
Description
Corona Disease Anxiety
Timepoint
Before the intervention, immediately after the end of the intervention, one month after the end of the intervention.
Method of measurement
Corona Disease Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention group of Covid-19 self-care training through WhatsApp software in the form of educational text messages, related images and video training (related videos) daily (8 am to 8 pm) with 2 to 3 messages for two They receive the week.
Category
Prevention
2
Description
Control group: During the training, the control group did not receive any training messages.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Hanie Amirifar
Street address
No23, Hekmat Ave
City
Andimeshk
Province
Khouzestan
Postal code
6481866455
Phone
+98 61 4263 5121
Email
amirifar7575@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyedmohammad Jamalian
Street address
Sardasht, Arak university of medical science
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
nursing.school@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hanie Amirifar
Position
Student Research Committee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 23, Hekmat Ave
City
Andimeshk
Province
Khouzestan
Postal code
6481866455
Phone
+98 61 4263 5121
Fax
Email
amirifar7575@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanie Amirifar
Position
Student Research Committee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 23, Hekmat Ave
City
Andimeshk
Province
Khouzestan
Postal code
6481866455
Phone
+98 61 4263 5121
Fax
Email
amirifar7575@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hanie Amirifar
Position
Student Research Committee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 23, Hekmat Ave
City
Andimeshk
Province
Khouzestan
Postal code
6481866455
Phone
+98 61 4263 5121
Fax
Email
amirifar7575@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