Objectives: To assess the effect of family-oriented care versus no care on quality of life in children with cancer.
Design: a randomized clinical trial.
Setting and conduct: The eligible children with cancer who may hospitalized in Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age of 2 to 15 years; having cancer; at least one month past from the diagnosis of the cancer; receiving at least two courses of chemotherapy.
Exclusion criteria: Physical or mental disorder; absence from educational sessions more than one session.
Intervention group: Routine treatment plus educational session of family-oriented care 40 minutes sessions daily for 4 days.
Control group: Just routine treatment.
Primary outcome: Assessing the quality of life before intervention and one month after that using standard questionnaire.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610039014N119
Registration date:2016-10-22, 1395/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-09-17, 1395/06/27
Expected recruitment end date
2017-09-18, 1396/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-oriented care versus no care on quality of life in children with cancer: a randomized clinical trial
Public title
The effect of family-oriented care versus no care on quality of life in children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 2 to 15 years; having cancer; at least one month past from the diagnosis of the cancer; receiving at least two courses of chemotherapy.
Exclusion criteria: Physical or mental disorder; absence from educational sessions more than one session.
Age
From 2 years old to 15 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2006-09-18, 1385/06/27
Ethics committee reference number
IR.UMSHA.REC.1395.303
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, unspecified
Primary outcomes
1
Description
Assessing the quality of life
Timepoint
before intervention and one month after that
Method of measurement
using standard questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus educational session of family-oriented care 40 minutes sessions daily for 4 days.
Category
Treatment - Other
2
Description
Control group: Just routine treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Zari Ravandi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
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
School of Nursing and Midwifery
Full name of responsible person
Zari Ravandi
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
zariravandi51@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Zari Ravandi
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
zariravandi51@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)