Determining the effect of virtual education on the burden of caregivers of breast cancer patients
Design
Clinical trial has a community-based control group, with parallel groups, a blind, randomized strain
Settings and conduct
In the intervention group, after an attendance meeting, the training package will be implemented within two months through virtual social networks. The intervention group will not receive intervention. Before, immediately and one month after the end of the intervention, caregiver burden will be compared in the two groups.
Participants/Inclusion and exclusion criteria
Entry requirements:
Literacy for reading and writing.
Not having disorders such as anxiety and depression.
Access and ability to use virtual social networks.
Passes at least 3 months of diagnosis.
Not participating in training courses in the last three months.
Exit Conditions:
Unwillingness to continue to study.
Attending a similar training program.
No full use of educational content.
Intervention groups
In the intervention group after an introduction, educational package will be implemented using cyberspace. Training will be implemented within two months through their social networks, whatsapp. The intervention group will not receive intervention.
Main outcome variables
Supply of basic knowledge and scientific evidence for organizations and institutions responsible for implementing preventive programs.
Helping community health workers about the design of future cyberspace interventions.
Improving the level of health and reducing cares in carers in patients with breast cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210930052640N1
Registration date:2021-11-08, 1400/08/17
Registration timing:registered_while_recruiting
Last update:2021-11-08, 1400/08/17
Update count:0
Registration date
2021-11-08, 1400/08/17
Registrant information
Name
Maryam Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 9584
Email address
Nouri.maryam98@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual education on the burden of care in caregivers of breast cancer patients
Public title
The effect of virtual education on the caregiver burden
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing .
Not having disorders such as anxiety and depression
Access and ability to use virtual social networks.
Passes at least 3 months of diagnosis.
Not participating in training courses in the last three months.
Exclusion criteria:
Unwillingness to continue to study.
Attending a similar training program.
No full use of educational content.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by randomized block design with quadruple blocks. The letter A is for the intervention group and the letter B is for the control group. Then we write all the permutation compounds, which are 6 different compounds, on 6 cards as follows: 1. AABB, 2. ABBA, 3. ABAB, 4. BAAB, 5. BABA, 6. BBAA, Then we will choose a digit from numbers 1 to 6 by drawing. For example, if the number 2 is selected, it means that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention 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
Ethics committee of Zanjan University of Medical Sciences
Street address
No. 99,Ghamat Bayat Alley, Airport St ,Zanjan city, Iran
City
Zanjan
Province
Zanjan
Postal code
4518959385
Approval date
2021-09-30, 1400/07/08
Ethics committee reference number
IR.ZUMS.REC.1400.284
Health conditions studied
1
Description of health condition studied
The effect of virtual education on the burden of caregivers of breast cancer patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Care load score less than 20
Timepoint
Caregivers whose patients have passed three months after diagnosis's three stages before and one month after the intervention
Method of measurement
Zarit Care burden Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After a face-to-face session to familiarize the training program the written training will be implemented using cyberspace.The general content of the training will be based on a review of texts related to the problems and educational needs of caregivers regarding the reduction of the care burden.But in compiling educational content after pre-test analysis,focus on the problems that had the most frequency and are in fact the educational needs of our target group.More time will be given and emphasized.These tutorials will be provided in the form of audio and video files.The training will take place over two months through the social networks they use WhatsApp.
Category
Behavior
2
Description
Control group: The control group will not receive any intervention.Before, immediately and one month after the intervention,the care burden of the two groups will be measured in person by completing questionnaires and the two groups will be compared in terms of the care load.If the intervention is effective,the control group will receive the intervention after the study.