The aim of current study is to determine the effect of implementing a care program on quality of life and uncertainty of adolescents with cancer in Isfahan city and is a kind of clinical trials with random allocation in two groups ( experiment and control) and before-after test. Inclusion criteria are age between 15-20, cancer diagnosis, and exclusion criteria are unwillingness to participation and obvious psychological disorder. Sample size is 60 ( 30 in experiment group and 30 in control group). In this study designed program based on adolescents need include self-care education, psychological consult and nutrition consult will implement for one month in experiment group and its effect will be assessed on quality of life and uncertainty. Control group will receive routine care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053128185N1
Registration date:2016-07-01, 1395/04/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Parastoo Oujian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3773 3771
Email address
p_oujian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Current study is funded by Isfahan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing care program on quality of life and uncertainty of adolescents with cancer aged 15-20 years of old
Public title
The effect of implementing care program on adolescent with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: adolescents with cancer age between 15-20 years of old; at least one time hospitalized for diagnostic and treatment procedures in Seid-o-Shohada center
Exclusion criteria: unwillingness to participate in any time and for any reason;confirmed psychological disorder by physician; failure to complete questionnaire
Age
From 1 year old to 96 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
Isfahan University Of Medical Sciences
Street address
Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8174643446
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
393502
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
EORTC QLQ-C30-Version 3.0 Quality of life Scale
Timepoint
before-after intervention
Method of measurement
questionaire
2
Description
Conner–Davidson Resilience Scale
Timepoint
before-after intervention
Method of measurement
questionaire
Secondary outcomes
empty
Intervention groups
1
Description
First step of intervention is self-care education provided by a nurse including personal hygiene, side-effects control and disease course education at least for 3 one-to-one sessions during adolescent hospitalization.
Category
Other
2
Description
Second part of intervention is psychological consult , coping strategies education at least for 1 one-to-one session by a psychologist during adolescent hospitalization.
Category
Other
3
Description
Third part of study is nutrition consult and providing nutrition regime during adolescent hospitalization.
Category
Other
4
Description
Control group will receive routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seid-o-Shohada Education and Treatment Centre
Full name of responsible person
Parastoo Oujian
Street address
Isfahan, Khayam Highway, Koye Nahre Farshadi
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Mahdi Nematbakhsh
Street address
Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Parastoo Oujian
Position
Phd Student
Other areas of specialty/work
Street address
Nursing and Midwifery school, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7516
Fax
Email
p_oujian@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Masoud Bahrami
Position
Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery school, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7516
Fax
Email
bahrami@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences, Nursing and Midwifery school
Full name of responsible person
Parastoo Oujian
Position
PhD student
Other areas of specialty/work
Street address
Nursing and Midwifery school, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
Fax
Email
p_oujian@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)