It is known that childhood cancer has a great effect on primary caregiver's quality of life. This randomized controlled trial study will examine the effectiveness of a Brief Psychosocial Intervention (BPI) on quality of life of Primary Caregivers of Children with Cancer (PCCCs). BPI including 5 counseling sessions and 5 phone calls follow up will be conducted by trained social workers. Data will be collected using the Caregiver Quality of Life Index, Cancer, Persian version (CQOLCP) prior to intervention and post intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031521487N1
Registration date:2015-06-07, 1394/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-07, 1394/03/17
Registrant information
Name
Atefeh Safarabadi Farahani
Name of organization / entity
University of social welfare and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 5455
Email address
atefeh_farahani@ymail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Brief Psychosocial Intervention (BPI) effectiveness on quality of life of primary caregivers of children with cancer
Public title
Study of Brief Psychosocial Intervention (BPI) effectiveness on quality of life of primary caregivers of children with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: be primary caregivers of children with cancer, be present at hospital at least one day per week, aged 18 or over; exclusion criteria: absence in more than 2 intervention sessions, the child's death
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomaized: blocked randomization method
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation sciences of Tehran
Street address
Kodakyar Ave, Daneshjo Blvd, Evin, Tehran
City
Tehran
Postal code
1985713834
Approval date
2014-09-15, 1393/06/24
Ethics committee reference number
911693011
Health conditions studied
1
Description of health condition studied
quality of life
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
The caregiver quality of life, cancer: CQOLCP
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: they will receive usual hospital intervention plus BPI. The BPI is a brief intervention designed to help improve the quality of life for PCCCs during all phases of the child illness. It will be accomplished by providing PCCCs with information and support through individual counseling sessions conducted by trained social worker. Several core components will be covered in a five session, 60 minute individual counseling and five phone call follow ups after each session. While the program has core components, each session will be tailored to fit the needs of PCCCs in the particular phase of child illness. The sessions will address individual psychosocial concerns.The first session will aim to engage and motivate PCCCs to participate and open communication. Second session will focus on optimistic attitude and include encourage optimistic thinking, sharing fears and negative thoughts and identify family strengths and weaknesses. Providing information about treatments and medication and help PCCCs live with uncertainty are aims of the third session. Fourth session will help PCCCs cope with stress and emphasize techniques to reduce stress, active coping strategies, and healthy lifestyle behaviors. In the fifth session self care strategies will be educated. PCCCs will be given homework assignments at each session and the assignment tasks will be reviewed at the start of the next session. Five phone calls follow up will be performed for all PCCCs.
Category
Lifestyle
2
Description
Control group: they will receive usual hospital intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
MAHAK highly specialized pediatric cancer hospital and research center
Full name of responsible person
Atefeh Safarabadi Farahani
Street address
Kodakyar Ave, Daneshjo Blvd, Evin, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Atefeh Safarabai Farahani
Street address
Kodakyar Ave, Daneshjo Blvd, Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences