To determine the effect of Peer Support-Based Online Education Program on the Burden of Care and Quality of Life of Patient's Family with Leukemia
Design
A none randomized clinical trial in two groups of intervention and control 80 participants divided into 40 people for each group will be done on family caregiver's of patient's with leukemia over a month
Settings and conduct
The study will be done in Shariati hospital where is one of the most significant center for hematology malignancy in Iran. successful peer families will be selected by the help of hematology and oncology head nurses and general self-efficacy questionnaire. The peer families will be educated in two sessions on an online platform. Afterward, a group will be established on social media to discuss and share the experience with other patient's leukemia caregivers. The researcher will educate caregivers to take care of patients through this group
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient's primary caregiver
The caregiver should be at age of 18 or over
The caregiver should be literate
Have an access to social media and smartphone
Consent participation in research
Exclusion criteria:
Caregiver addiction
Having a distinct mental disorder of the caregiver
Taking sedative medicine by caregiver
Intervention groups
The following research is about peer support-based online education programs on patient's families with Leukemia. The intervention group will receive online support from other families who have the same experience of caring for a leukemia patient. In addition, caregivers will be educated through social media platforms by researcher.
The control group will receive ward care routines by nurses and doctors
Main outcome variables
Leukemia, burden of care, quality of life, online, peer, peer support, family of patient's with leukemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210507051209N1
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Mehrnaz Keramatikerman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3322 9951
Email address
me.keramati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Peer Support-Based Online Education Program on the Burden of Care and Quality of Life of Patient's Family with Leukemia
Public title
Effect of Peer Support-based online education on family patients with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's primary caregiver
The caregiver should be at age of 18 or over
The caregiver should be literate
Have an access to social media and smart phone
Consent participation in reaserch
Exclusion criteria:
Age
From 18 years old to 60 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
Ethics committee of Tehran University of Medical Sciences
Street address
4th floor, No 19, Ataei alley,1st street, D block, Valfajr, Afsariyeh
City
Tehran
Province
Tehran
Postal code
1786956635
Approval date
2021-06-20, 1400/03/30
Ethics committee reference number
IR.TUMS.FNM.REC.1400.049
Health conditions studied
1
Description of health condition studied
Plasma cell Leukemia
ICD-10 code
C90.1
ICD-10 code description
Plasma cell leukemia
Primary outcomes
1
Description
The proportion of caregivers emotional of burden is less than 20% in zarit questionnaire
Timepoint
Before initiating the study and a month later of intervention
Method of measurement
Zarit Burden questionnaire
2
Description
The proportion of caregivers quality of life is at most 140 in CQOLC-P questionnaire
Timepoint
Before initiating the study and a month later of intervention
Method of measurement
The Caregiver Quality of Life Index–Cancer
Secondary outcomes
1
Description
Score of care burden
Timepoint
Before initiating and a month later intervention
Method of measurement
Zarit Burden Interview
2
Description
Score of quality of life
Timepoint
Before initiating and a month later intervention
Method of measurement
CQOLC-P
Intervention groups
1
Description
Intervention group: The caregivers will received peer support-based online education program by 5 peer supports who are educated by researcher. The education study will be continued for a month and the sessions will be held 4 days a week in 2 hours. The researcher will answer caregivers questions and peer supports share their common experiences in the social media platforms. Peer supports will be chosen among 2 men and 3 women
Category
Rehabilitation
2
Description
Control group: The caregivers only will be received routine care by nurses in the wards