The main goal :
Determination the effect of a Partnership Care Model on Quality of Life and Anxiety in Patients with Hematological Cancer.
Sub-goals:
1) Comparison of Quality of Life and its different domains in Patients with Leukemia in the "intervention" group before and after intervention.
2) Comparison of Quality of Life and its different domains in Patients with Leukemia in the "control" group before and after intervention.
3-4) Comparison of Quality of Life and its different domains in Patients with leukemia; Between the Intervention and Control groups before and after intervention.
5) Comparison of anxiety in Patients with Leukemia in the intervention group before and after intervention.
6) Comparison of anxiety in Patients with Leukemia in the control group before and after the intervention.
7-8) Comparison of anxiety in Patients with Leukemia in between intervention and control group before and after intervention.
Design
Clinical trial with control group ;paralleled, unblinking, randomized groups with a sample size of 60 persons.
Settings and conduct
Intervention in Oncology Ward of Firouzgar and Rasoul Hospitals of Tehran was carried out. With coin throwing and randomly, the Oncology Ward of the Firouzgar Hospital was investigated an intervention group and Oncology Ward of Rasoul Hospital was investigated as a control group.
Participants/Inclusion and exclusion criteria
The population of the study included all Adults patients with Leukemia admitted in the oncology departments of Rasoul-e-Akhram and Firoozghar hospitals affiliated to Iran University of Medical Sciences.
Intervention groups
Intervention group: Patients in the Oncology ward of the Firouzgar Hospital, and the intervention method is a Participatory Care Model.
Control group: Patients in the Oncology ward of Hazrat Rasoul Hospital.
Main outcome variables
Quality of life; Anxiety
General information
Reason for update
Acronym
PQAH
IRCT registration information
IRCT registration number:IRCT20181019041381N1
Registration date:2018-12-06, 1397/09/15
Registration timing:retrospective
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
shaqayeq sediq
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5502 1516
Email address
sediq92m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2018-02-21, 1396/12/02
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
2018-07-23, 1397/05/01
Scientific title
The effect of a Partnership Care Model on Quality of Life and Anxiety in Patients with Hematological Cancer.
Public title
The effect of a Partnership Care Model on Quality of Life and Anxiety in Patients with Hematological Cancer.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of hematological cancer in a patient's medical records by a doctor
Ability of communication
Ability of seeing and listening
Ability to reading and writing
Ability to come back to hospital after Intervention
Do Not having a known psychological disorder
The presence of a family member of the patient in all participatory-educational sessions
Exclusion criteria:
Patient’s death
Failure of the client or his family to attend to even 1 section of intervention
Another illness that leads to hospitalization.
Cases of malignant diseases and other chronic diseases after entering the study.
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:
60
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
With the coin throwing method between Rasoul Akram Hospital and Tehran Firouzgar Hospital ; A hospital was selected as the control hospital and the other as an intervention hospital.
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 Iran University of Medical Sciences
Street address
Nursing and Midwifery Faculty of Iran University of Medical Science ,Rashid Yasemi Alley,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1883973843
Approval date
2018-01-22, 1396/11/02
Ethics committee reference number
.ir.iums.fmdrec.1396.9411686008
Health conditions studied
1
Description of health condition studied
Hematological Cancer
ICD-10 code
C95.9
ICD-10 code description
Leukemia, unspecified
Primary outcomes
1
Description
Measurement of Quality of Life in patients with "Quality of Life questionnaire in Patients with cancer" or in brief QLQ-C30 and Measurement of Anxiety in patients with "Beck Anxiety Inventory Questionnaire".
Timepoint
Measurement of quality of life and anxiety in patients before intervention and one and three months after intervention.
Method of measurement
Cancer Quality of Life Questionnaire and Beck Anxiety Inventory questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 30 patients were randomly selected and a Partnership Care Model was performed on them. Then, The Quality of life of cancer patients questionnaire and Beck anxiety inventory questionnaire were filled before intervention and one and three months after the intervention by patients.
Category
Lifestyle
2
Description
Control group: 30 Patients were randomly selected in this group. Then, the Quality of life of patients with cancer and Beck anxiety inventory questionnaires were completed before and one and three months later by patients.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Shaqayeq sediq
Street address
Firuzgar hospital, Behafarin St, Valiasr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
sediq92m@yahoo.com
2
Recruitment center
Name of recruitment center
Hazrat Rasool hospital
Full name of responsible person
Sediq Shaghayegh
Street address
Rasul-e-akram Hospital , Mansuri St , Satarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
sediq92m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alice khachian
Street address
Nursing and Midwifery Faculty of Iran University of Medical Science ,Rashid Yasemi Alley,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
sediq92m@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
shaqayeq sediq
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Iran University of Medical Science ,Rashid Yasemi Alley,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1883973843
Phone
+98 21 4365 1000
Email
sediq92m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shaqayeq Sediq
Position
Mater Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Iran University of Medical Science ,Rashid Yasemi Alley,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1883973843
Phone
+98 21 4365 1000
Email
sediq92m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shaqayeq Sediq
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Iran University of Medical Science ,Rashid Yasemi Alley,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1883973843
Phone
+98 21 4365 1000
Email
sediq92m@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data is available in the Library of the Faculty of Nursing, in Iran University of Medical Sciences after completion of the dissertation.
When the data will become available and for how long
Data is always available in the Library of the Faculty of Nursing,in Iran University of Medical Sciences after completion of the dissertation.
To whom data/document is available
Data is always available to the public in the Library of the Faculty of Nursing,in Iran University of Medical Sciences after completion of the dissertation.
Under which criteria data/document could be used
Data is always available in the Library of the Faculty of Nursing,In Iran University of Medical Sciences after completion of the dissertation.It is possible to use by mention the source of the data.
From where data/document is obtainable
Data is always available in the Library of the Faculty of Nursing,in Iran University of Medical Sciences after completion of the dissertation.
What processes are involved for a request to access data/document
Data is always available in the Library of the Faculty of Nursing,in Iran University of Medical Sciences after completion of the dissertation.