The present study aims to determine the impact of planned social support on the resilience of informal caregivers of cancer patients.
Design
The clinical trial study has a control group, two groups, and in each group 46 people (96 people in total) are allocated by simple random method.
Settings and conduct
In this study, family caregivers of cancer patients referred to the oncology departments of Shariati Hospital in Tehran will be included in two intervention and control groups. In the intervention group, the social support program is conducted face-to-face and virtually in 4 areas: informational, emotional, instrumental and evaluation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Over 18 years of care
At least three months have passed since the diagnosis of cancer by the doctor
The average duration of care is 31 hours per week, for a minimum of three months
Being literate in reading and writing in Persian language
Smartphone access
Willingness to participate in the intervention
Physical ability to participate in the face-to-face program
A resident of Tehran
Access to smart mobile and internet and the ability to use it
Non-abuse of psychoactive substances and narcotics through self-report
Non-inclusion criteria:
Abuse of psychoactive substances and narcotics through self-report
Participate in similar programs
Intervention groups
In this study, in the intervention group, face-to-face and virtual training will be conducted under the title of social support program. In the control group, there is no intervention for people caring for cancer patients (routine procedure).
Main outcome variables
Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221120056560N1
Registration date:2023-01-26, 1401/11/06
Registration timing:registered_while_recruiting
Last update:2023-01-26, 1401/11/06
Update count:0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
masoomeh yousefvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 866 3065
Email address
masoomyousefvand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of social support Program on resiliency of informal caregivers among patients suffering from cancer
Public title
The effect of social support Program on resiliency of caregivers of cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of care
At least three months have passed since the diagnosis of cancer by the doctor
The average duration of care is 31 hours per week, for a minimum of three months
Being literate in reading and writing in Persian language
Smartphone access
Willingness to participate in the intervention
Physical ability to participate in the face-to-face program
A resident of Tehran
Access to smart mobile and internet and the ability to use it
Non-abuse of psychoactive substances and narcotics through self-report
Exclusion criteria:
Abuse of psychoactive substances and narcotics through self-report
Participate in similar programs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the allocation of people into two groups is done in a simple random way, using even and odd methods. In this way, people with an odd number are placed in the intervention group and with an even number in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Oncology, Hematology and Tuberculosis Research Institute, Tehran University of M
Street address
North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1401.018
Health conditions studied
1
Description of health condition studied
Resiliency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resilience
Timepoint
Before the study, immediately and 6 weeks after the end of the intervention
Method of measurement
Connor and Davidson Resilience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Integrated face-to-face and virtual training under the title of social support program is carried out in 4 areas: informational, emotional, instrumental and evaluation.
Category
Other
2
Description
Control group: There is no intervention for people caring for cancer patients (routine procedure).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, Tehran
Full name of responsible person
Ahmad Reza Jamshidi
Street address
North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Vaezi
Street address
North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8490 2635
Email
horcbmt@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seryeh pourtaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6105 4209
Email
s-poortaghi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seryeh pourtaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6105 4209
Email
s-poortaghi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Yousefvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Amirabad, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6105 4209
Fax
Email
masoomyousefvand@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